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Sample records for on-pump off-pump randomisation

  1. Off-Pump Versus On-Pump Coronary Artery Bypass Grafting

    DEFF Research Database (Denmark)

    Møller, Christian H; Steinbrüchel, Daniel A

    2014-01-01

    Coronary artery bypass grafting (CABG) remains the preferred treatment in patients with complex coronary artery disease. However, whether the procedure should be performed with or without the use of cardiopulmonary bypass, referred to as off-pump and on-pump CABG, is still up for debate....... Intuitively, avoidance of cardiopulmonary bypass seems beneficial as the systemic inflammatory response from extracorporeal circulation is omitted, but no single randomized trial has been able to prove off-pump CABG superior to on-pump CABG as regards the hard outcomes death, stroke or myocardial infarction....... In contrast, off-pump CABG is technically more challenging and may be associated with increased risk of incomplete revascularization. The purpose of the review is to summarize the current literature comparing outcomes of off-pump versus on-pump coronary artery bypass surgery....

  2. Five-Year Outcomes after On-Pump and Off-Pump Coronary-Artery Bypass.

    Science.gov (United States)

    Shroyer, A Laurie; Hattler, Brack; Wagner, Todd H; Collins, Joseph F; Baltz, Janet H; Quin, Jacquelyn A; Almassi, G Hossein; Kozora, Elizabeth; Bakaeen, Faisal; Cleveland, Joseph C; Bishawi, Muath; Grover, Frederick L

    2017-08-17

    Coronary-artery bypass grafting (CABG) surgery may be performed either with cardiopulmonary bypass (on pump) or without cardiopulmonary bypass (off pump). We report the 5-year clinical outcomes in patients who had been included in the Veterans Affairs trial of on-pump versus off-pump CABG. From February 2002 through June 2007, we randomly assigned 2203 patients at 18 medical centers to undergo either on-pump or off-pump CABG, with 1-year assessments completed by May 2008. The two primary 5-year outcomes were death from any cause and a composite outcome of major adverse cardiovascular events, defined as death from any cause, repeat revascularization (CABG or percutaneous coronary intervention), or nonfatal myocardial infarction. Secondary 5-year outcomes included death from cardiac causes, repeat revascularization, and nonfatal myocardial infarction. Primary outcomes were assessed at a P value of 0.05 or less, and secondary outcomes at a P value of 0.01 or less. The rate of death at 5 years was 15.2% in the off-pump group versus 11.9% in the on-pump group (relative risk, 1.28; 95% confidence interval [CI], 1.03 to 1.58; P=0.02). The rate of major adverse cardiovascular events at 5 years was 31.0% in the off-pump group versus 27.1% in the on-pump group (relative risk, 1.14; 95% CI, 1.00 to 1.30; P=0.046). For the 5-year secondary outcomes, no significant differences were observed: for nonfatal myocardial infarction, the rate was 12.1% in the off-pump group and 9.6% in the on-pump group (P=0.05); for death from cardiac causes, the rate was 6.3% and 5.3%, respectively (P=0.29); for repeat revascularization, the rate was 13.1% and 11.9%, respectively (P=0.39); and for repeat CABG, the rate was 1.4% and 0.5%, respectively (P=0.02). In this randomized trial, off-pump CABG led to lower rates of 5-year survival and event-free survival than on-pump CABG. (Funded by the Department of Veterans Affairs Office of Research and Development Cooperative Studies Program and others

  3. Immediate pulmonary dysfunction in ischemic heart disease patients undergoing off-pump versus on-pump CABG

    Directory of Open Access Journals (Sweden)

    Ashraf Helal Abd-Allah

    2016-05-01

    Conclusion: Pulmonary functions deteriorate significantly after coronary artery revascularization with and without CPB, but to a significant greater reduction among those on-pump than among those off-pump surgeries.

  4. Off-pump and on-pump coronary artery bypass surgery:time to move on

    Institute of Scientific and Technical Information of China (English)

    Shahzad G Raja

    2004-01-01

    @@ To the editor: Chen and colleagues,1 and the editorial staff of the Chinese Medical Journal, deserve much credit for carrying out and publishing a prospective comparative study of on-pump and off-pump coronary artery bypass (OPCAB) surgery in 300 patients with triple-vessel coronary artery disease. Although this study is limited by non-randomization and selection bias yet contrary to the previously published prospective, randomized studies by Van Dijk et al,2 and Ascione et al,3 the patient population of this study is more representative of current coronary artery surgery practices. Even more important is the conclusion that OPCAB can be applied to patients with triple-vessel coronary artery disease and "in experienced hands" can achieve similar completeness of revascularization and similar early surgical results.

  5. On-pump versus off-pump coronary artery bypass surgery

    DEFF Research Database (Denmark)

    Houlind, Kim Christian

    2013-01-01

    Off pump coronary artery bypass surgery has been purported to be safer than conventional coronary artery bypass surgery performed using cardiopulmonary bypass. This theory was supported by a number of early series, but failed to be confirmed by a number of small, randomized controlled trials...... . Conversely, it has been suggested that revascularization after off pump surgery is associated with fewer grafts and lower graft patency, potentially leading to a higher risk of cardiovascular morbidity and need for repeated, coronary interventions. Since 2009, three major randomized controlled trials have...

  6. On-Pump Versus Off-Pump Coronary Artery Bypass Surgery in Elderly Patients

    DEFF Research Database (Denmark)

    Holme, Susanne Juel; Houlind, Kim; Kjeldsen, Bo Juul;

    2012-01-01

    Conventional coronary artery bypass grafting performed with the use of cardiopulmonary bypass is a well-validated treatment for patients with ischemic heart disease. Off-pump coronary artery bypass grafting (OPCAB) has been suggested to reduce the number of perioperative complications, especially...... in elderly patients....

  7. On-pump versus off-pump coronary artery bypass surgery

    DEFF Research Database (Denmark)

    Houlind, Kim Christian

    2013-01-01

    Off pump coronary artery bypass surgery has been purported to be safer than conventional coronary artery bypass surgery performed using cardiopulmonary bypass. This theory was supported by a number of early series, but failed to be confirmed by a number of small, randomized controlled trials . Co...

  8. Enhanced intracellular heat shock protein 70 expression of leukocytes and serum interleukins release: comparison of on-pump and off-pump coronary artery surgery.

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    Lin, Chih-Yuan; Yang, Tung-Lin; Hong, Gou-Jieng; Li, Chi-Yuan; Lin, Feng-Yen; Tsai, Chien-Sung

    2010-04-01

    Coronary artery bypass grafting (CABG) employing cardiopulmonary bypass (CPB; "on-pump" technique) is known to induce a systemic inflammatory response and heat-shock protein 70 kDa (HSP70) expression. The objective of the present study was to investigate the perioperative intracellular HSP70 expression of leukocytes and serum interleukin (IL) release in CABG conducted with both on-pump and off-pump techniques. Thirty-seven patients referred for elective CABG were enrolled in this study. These patients were categorized into the following three groups: on-pump cardioplegic arrest (n = 12); on-pump beating heart (n = 13); and off-pump (n = 12). Blood samples were collected at four time points during the perioperative period. Enzyme-linked immunosorbent assay (ELISA) was used to determine the serum level of IL-8, IL-10, IL-12, and HSP70. Flow cytometric analysis of intracellular HSP70 was performed in populations of lymphocytes, monocytes, and granulocytes. The clinical outcomes were comparable among the three groups. Elevated serum IL-8, IL-10, IL-12 were found in all three groups during the perioperative period. Serum HSP70 was elevated in all three groups and was significantly lower in the off-pump group than in the on-pump cardioplegic arrest and on-pump beating-heart groups. Heat shock protein-70 expression was found in leukocytes and showed a faster response in monocytes and granulocytes than in lymphocytes. The inflammatory response in the off-pump group was less than in either of the on-pump groups. During the perioperative period, activation of inflammatory response was associated with enhanced expression of HSP70 within leukocytes in CABG patients.

  9. Health-related quality of life following off-pump versus on-pump coronary artery bypass grafting in elderly moderate to high-risk patients

    DEFF Research Database (Denmark)

    Jensen, Birte Østergaard; Hughes, Pia; Rasmussen, Lars S;

    2006-01-01

    Previous trials comparing coronary artery bypass grafting (CABG) with or without extracorporeal circulation have mainly enrolled selected patients at younger age and low risk. Patient-reported health-related quality of life has not been significantly different. We compared health-related quality...... of life in elderly moderate to high-risk patients randomized to either off-pump or on-pump surgery....

  10. Heat shock proteins 27, 60, 70, 90alpha, and 20S proteasome in on-pump versus off-pump coronary artery bypass graft patients.

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    Szerafin, Tamas; Hoetzenecker, Konrad; Hacker, Stefan; Horvath, Ambrus; Pollreisz, Andreas; Arpád, Péterffy; Mangold, Andreas; Wliszczak, Tina; Dworschak, Martin; Seitelberger, Rainald; Wolner, Ernst; Ankersmit, Hendrik J

    2008-01-01

    The secretion of heat shock protein (HSP) 27, HSP60, HSP70, HSP90alpha, 20S proteasome, and their correlations to proinflammatory cytokine interleukin-6 is unknown in patients undergoing on-pump versus off-pump coronary artery bypass graft (CABG) operation. Forty patients were included in this explorative study (on- versus off-pump CABG, each n = 20). Serum samples were obtained before and 30 minutes, 60 minutes, and 24 hours after CABG operation. Enzyme-linked immunosorbent assay technique was utilized to determine soluble HSP27, 60, 70, and 90alpha, 20S proteasome, and levels of interleukin-6. Serum levels of HSP are increased in patients undergoing on-pump CABG operation as compared with off-pump CABG technique. These differences were highly significant for HSP27, 70, and 90alpha at 60 minutes after initiation of cardiopulmonary bypass (all, p pump CABG patients (p < 0.001) and correlated significantly with the serum content of HSP 27, 70, and 90alpha at 60 minutes after initiation of cardiopulmonary bypass (p < 0.001). No correlation was found when comparing interleukin-6 levels with intravascular leakage of HSP and 20S proteasome after CABG operation. We conclude from our data that the innate immune system is activated owing to spillage of known immune modulatory and apoptosis-associated proteins after CABG operation.

  11. A Multidisciplinary Approach to Unplanned Conversion from Off-Pump to On-Pump Beating Heart Coronary Artery Revascularization in Patients with Compromised Left Ventricular Function

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    Georgia Tsaousi

    2014-01-01

    Full Text Available Aim. To comparably assess the perioperative risk factors that differentiate off-pump coronary artery bypass (OPCAB grafting cases from those sustaining unplanned conversion to on-pump beating heart (ONCAB/BH approach, in patients with left ventricular ejection fraction (LVEF 2 days (P=0.007. Conclusions. Patients with LVEF < 40% undergoing ONCAB/BH are subjected to more preoperative comorbidities and implicated ICU stay than their OPCAB counterparts, which influences adversely short-term morbidity, while operative mortality remains unaffected.

  12. Meta-analysis of randomized trials comparing the effectiveness of on-pump and off-pump coronary artery bypass

    Institute of Scientific and Technical Information of China (English)

    CHEN Yong-bing; SHU Jian; YANG Wen-tao; SHI Li; GUO Xu-feng; WANG Fei-ge; QIAN Yong-yue

    2012-01-01

    Background The growing enthusiasm for coronary artery bypass grafting (CABG) without cardiopulmonary bypass (CPB) is emerging,but the role of off-pump coronary artery bypass (OPCAB) in clinical practice remains controversial.The purpose of this study was to assess differences in the incidences of stroke,atrial fibrillation (AF),and myocardial infarction (MI) between OPCAB and conventional coronary artery bypass grafting (CCABG) by meta-analyses of randomized clinical trials.Methods A literature search for the period before March 2010 supplemented with manual bibliographic review was performed for all Chinese or English publications in Medline,the Science Citation Index Expanded,the Cochrane Central Register of Controlled Trials (CENTRAL) and CBMdisc.A systematic overview (meta-analyses) of randomized clinical trials was conducted to evaluate the differences between OPCAB and CCABG in the incidences of stroke,AF,and MI.The meta-analysis was performed using RevMan 5 software.Results Forty-three randomized clinical trials were selected for meta-analysis after screening a total of 356 references,with 8104 patients in the OPCAB group and 8724 cases in the CCABG group.The meta-analyses of these trials showed no significant difference between OPCAB and CCABG in the incidences of stroke (odds ratio (OR)=0.80,95% confidence interval (CI)=0.52-1.22,P=0.30) and MI (OR=0.73,95%CI=0.52-1.02,P=0.06).However,we found a significantly reduced risk of AF (OR=0.65,95%CI =0.52-0.82,P=0.0002)in off-pump patients.Conclusions Our meta-analyses suggest that OPCAB reduces the risk of postoperative AF compared with CCABG,but there is no significant difference in the incidences of stroke and MI between OPCAB and CCABG.

  13. Off-pump coronary artery bypass grafting versus on-pump coronary artery bypass grafting: which is better in patients with chronic obstructive pulmonary disease?

    Institute of Scientific and Technical Information of China (English)

    朱亚彬; 许建屏; 刘志勇; 杨丹宁; 李旭东; 李鸿雁

    2004-01-01

    To evaluate the clinic outcome of off-pump coronary bypass grafting (OPCABG) of patients with coronary heart disease and chronic obstructive pulmonary disease, we collected and analyzed 1998-2002 data on 28 patients with these two diseases who had received off-pump coronary bypass operation in our hospital, and compared with data on those who also had the same two diseases but received on-pump coronary artery bypass at same time. There were no operation-related death;one died of respiratory failure 14 days after operation while staying in hospital; there were more respiratory complications in the conventional coronary artery bypass grafting group (CCABG) than in the OPCABG group; and the PaO2/FiO2 in the CCABG group was higher than that in the OPCABG group during operation because of CPB, but lower than that in the OPCABG group 6-12 hours after operation. OPCABG seemed more suitable than CCABG for coronary artery disease patients with chronic obstructive pulmonary disease due to less damage to their oxygen-exchange capability and the fewer respiratory complications.

  14. Off-pump coronary artery bypass grafting versus on-pump coronary artery bypass grafting:which is better in patients with chronic obstructive pulmonary disease?

    Institute of Scientific and Technical Information of China (English)

    朱亚彬; 许建屏; 刘志勇; 杨丹宁; 李旭东; 李鸿雁

    2004-01-01

    To evaluate the clinic outcome of off-pump coronary bypass grafting (OPCABG) of patients with coronary heart disease and chronic obstructive pulmonary disease, we collected and analyzed 1998-2002 data on 28 patients with these two diseases who had received off-pump coronary bypass operation in our hospital, and compared with data on those who also had the same two diseases but received on-pump coronary artery bypass at same time. There were no operation-related death;one died of respiratory failure 14 days after operation while staying in hospital; there were more respiratory complications in the conventional coronary artery bypass grafting group (CCABG) than in the OPCABG group; and the PaO2/FiO2 in the CCABG group was higher than that in the OPCABG group during operation because of CPB, but lower than that in the OPCABG group 6-12 hours after operation. OPCABG seemed more suitable than CCABG for coronary artery disease patients with chronic obstructive pulmonary disease due to less damage to their oxygen-exchange capability and the fewer respiratory complications.

  15. Comparative study of on-pump and off-pump coronary bypass surgery in patients with triple-vessel coronary artery disease

    Institute of Scientific and Technical Information of China (English)

    陈鑫; 徐明; 史宏伟; 穆心伟; 陈振强; 邱志兵

    2004-01-01

    Background Studies on selected patients undergoing off-pump versus on-pump coronary artery bypass surgery have produced inconsistent results, especially in patients with multiple coronary artery disease. This study compared the clinical results of on-pump and off-pump coronary bypass surgery in patients with triple-vessel disease.Methods A total of 300 consecutive isolated, multiple coronary artery bypass grafting (CABG) patients were assigned to the off-pump coronary artery bypass (OPCAB, n=150) or CABG with cardiopulmonary bypass (CCABG, n=150) groups. There were no significant differences regarding degree of angina, history of myocardial infarction or diabetes, and presence of left main coronary artery disease between the two groups. Ejection fraction in the OPCAB group before surgery was lower than in the CCABG group (P<0.01). In addition, more patients had a history of stroke and abnormal renal function preoperatively in the OPCAB group(P< 0.01). In OPCAB patients, single deep pericardial stay suture with a sling snared down was used to expose the target vessels, along with a stabilizer and a coronary shunt. A Medi-Stim Butterfly Flowmeter was used to measure blood flow through grafts in both groups.Results No OPCAB patient was converted to the CCABG group. The average numbers of distal anastomoses and the indexes of completeness of revascularization (ICR) were similar in both groups. Postoperative respiratory support time and the volumes of chest tube drainage and of blood transfusions were less in the OPCAB group than in the CCABG group (both P<0.01). The postoperative incidences of pulmonary dysfunction and renal insufficiency were lower in the OPCAB group than in the CCABG group (both P<0.05). There were no significant differences between the two groups in mortality and other causes of morbidity (periopetative myocardial infarction, stroke, atrial fibrillation). Conclusions OPCAB can be applied to patients with triple-vessel coronary artery disease and can

  16. On-pump with beating heart or cardioplegic arrest for emergency conversion to cardiopulmonary bypass during off-pump coronary artery bypass.

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    Yu, Lei; Gu, Tianxiang; Shi, Enyi; Wang, Chun; Fang, Qin; Zhang, Yuhai; Lu, Chunmao

    2014-01-01

    Intraoperative conversion, especially under emergent circumstances during off-pump coronary artery bypass (OPCAB), is associated with a significantly higher rate of hospital mortality. This study compared the clinical early outcomes of patients emergently converting to cardiopulmonary bypass (CPB) with or without cardioplegic arrest and evaluated the efficacy of an on-pump beating heart technique for these critically ill patients. A retrospective study of patients treated at The First Affiliated Hospital of China Medical University over an 8-year period (2005 to 2013). Between January 2005 and September 2013, 104 patients were emergently converted to CPB during OPCAB. In the first 55 patients (53%), the cardioplegic arrest was performed. In the most recent 49 patients (47%), the on-pump beating heart procedure was used without cardioplegic arrest. There were no significant differences in their baseline clinical characteristics, number of anastomoses performed per patient, and reasons for conversions (P > .05). A significant reduction occurred in the observed mortality between the cardioplegic arrest group and the on-pump beating heart group (25.6% vs 6.1%, P=.008). A statistical difference was found between the cardioplegic arrest group and the on-pump beating heart group in the time of CPB, peak cardiac troponin I, duration of inotropic support, time to extubation, intensive care unit stay, postoperative hospital stay, incidence of new intra-aortic balloon pump support, and pulmonary complications (P .05). The on-pump beating heart technique is the preferred method of emergency conversion to CPB during OPCAB. It has lower postoperative mortality and morbidity than the cardioplegic arrest.

  17. A randomised trial to evaluate preoperative oral carbohydrate administration on insulin resistance in off-pump coronary artery bypass patients.

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    Lee, Bora; Soh, Sarah; Shim, Jae-Kwang; Kim, Ha Y; Lee, Hyelin; Kwak, Young-Lan

    2017-04-21

    In fasting cardiac surgery patients, preoperative carbohydrate (CHO) drink intake attenuated insulin resistance and improved cardiac metabolism, although its beneficial effects were not evident after cardiac surgery possibly due to cardiopulmonary bypass-related extreme systemic inflammation. We aimed to evaluate whether preoperative CHO intake affected insulin resistance and free-fatty acid (FFA) concentrations in off-pump coronary revascularisation. A randomised controlled trial. Primary care in a university hospital in Korea from January 2015 to July 2016. Sixty patients who underwent elective multi-vessel off-pump coronary revascularisation were randomised into two groups. Three patients were excluded from analysis and 57 patients completed study. The CHO group received oral CHO (400 ml) the prior evening and 2 to 3 h before surgery, and the control group was fasted from food and water according to standard protocol. Insulin resistance was assessed twice, after anaesthetic induction and after surgery via short insulin tolerance test. FFA, C-reactive protein and creatine kinase-myocardial band concentrations were determined serially for 48 h after surgery. Insulin sensitivity was greater (P = 0.002) and plasma FFA concentrations were lower (P = 0.001) after anaesthetic induction in the CHO group compared with the Control group, although there were no intergroup differences after surgery. The postoperative peak creatine kinase-myocardial band concentration was significantly lower in the CHO group compared with the Control group [8.8 (5.4 to 18.2) vs. 6.4 (3.5 to 9.7) ng ml, P = 0.031]. A preoperative CHO supplement significantly reduced insulin resistance and FFA concentrations compared with fasting at the beginning of the surgery, but these benefits were lost after off-pump coronary revascularisation. Despite their transient nature, these beneficial effects resulted in less myocardial injury, mandating further studies focused on the impact

  18. A comparison of survival between on-pump and off-pump left internal mammary artery bypass graft surgery for isolated left anterior descending coronary artery disease: an analysis of the UK National Adult Cardiac Surgery Audit Registry.

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    Hickey, Graeme L; Pullan, Mark; Oo, Aung; Mediratta, Neeraj; Chalmers, John; Bridgewater, Ben; Poullis, Michael

    2016-05-01

    To determine if the use of cardiopulmonary bypass is associated with all-cause in-hospital and mid-term survival for patients undergoing left internal mammary artery (LIMA) to left anterior descending (LAD) coronary artery bypass grafting (CABG) for single coronary vessel disease. Data from the National Adult Cardiac Surgery Audit registry for all elective and urgent isolated CABG procedures performed between April 2003 and March 2013 in first-time cardiac surgery patients were extracted. Experienced surgeons (those with ≥300 records) were classified by their technique preference (as 'off-pump preference', 'mixed practice', 'on-pump preference') based on their entire isolated CABG data. In-hospital mortality and time to death were analysed using logistic and Cox proportional hazards regression models, respectively. From a total of 3402 records, 65.5% were performed off-pump. There were 16 (0.47%) in-hospital deaths: 6 (0.51%) in the on-pump group and 10 (0.45%) in the off-pump group. The risk-adjusted odds ratio of in-hospital mortality in the direction of on-pump was 1.09 [95% confidence interval (CI): 0.39-3.04; P = 0.86]. The overall 5-year survival in the on- and off-pump groups was 93.1 and 93.4%, respectively. The adjusted hazard ratio (HR) for mortality in the direction of on-pump CABG was 1.15 (95% CI: 0.89-1.49; P = 0.28). Comparing off-pump cases performed by experienced CABG surgeons with a preference for the off-pump technique with on-pump cases performed by surgeons with a preference for the on-pump technique indicated a significant difference (HR for on-pump = 1.72; 95% CI: 1.19-2.47; P = 0.004). Elective and urgent first-time CABG for isolated LAD disease is associated with excellent mid-term survival in the England and Wales population, conferring a 5-year survival rate of 93.1 and 93.4% in the on-pump and off-pump groups, respectively. There was no difference in risk-adjusted survival between the on-pump and off-pump techniques when analysing all

  19. Outcomes of off-pump versus on-pump coronary artery bypass graft surgery in patients with severely dilated left ventricle

    Science.gov (United States)

    Li, Sen; Gong, Wenhui; Qi, Quan; Yuan, Zezhe; Chen, Anqing; Liu, Jun; Cai, Junfeng; Zhou, Mi

    2016-01-01

    Background Currently, off-pump coronary artery bypass (OPCAB) grafting has been the standard procedure for surgical revascularization in patients with coronary artery disease (CAD). This study aimed to examine the safety and applicability of OPCAB compared with on-pump coronary artery bypass (ONCAB) in patients with severely dilated left ventricle. Methods A retrospective study of giant left ventricle patients [left ventricular end diastolic diameter (LVEDD) ≥ VE mm] undergoing coronary bypass grafting from 2009 through 2015 at a single center was conducted. Preoperative and intraoperative risk factors, and postoperative outcomes were analyzed. Survival analysis was carried to analyze survival rate during follow-up. Results A total of 24 patients underwent ONCAB, and 26 underwent OPCAB. Both groups had similar preoperative profiles. Two cases from each group died during in-hospital time. In comparison to OPCAB, there was longer operation and post-surgery intubation time and more renal dysfunction in ONCAB group (P0.05). Conclusions OPCAB is a safe and feasible alternative for CAD patients with giant left ventricle, offering a significant advantage over ONCAB with regards to renal function, operation duration and length of ventilation. PMID:27761444

  20. Comparative study of graft flow between on-pump and off-pump coronary bypass surgery for patients with multivessel coronary artery disease

    Institute of Scientific and Technical Information of China (English)

    Xin Chen; Ming Xu; Zhibing Qiu; Yinshuo Jiang; Liming Wang; Liqiong Xiao

    2006-01-01

    Objective: To Comparatively study grafts flow between on-pump and off-pump coronary bypass surgery for patients with triple coronary artery disease. Methods: The grafts flow was studied in 100 patients of OPCAB and compared with100 cases of CCABG by means of Medi-Stim Butterfly Flowmeter measurement intraoperatively. Results: The mean number of the distal anastomosis was 3.78+ 1.11 in CCABG group, and 3.83 + 0.93 in OPCAB group. The index of completeness of revascularization in CCABG group was 1.01 + 0.08, and 1.10+ 0.09 in OPCAB group. The flow of grafts was satisfied in all patients. The PI values were all under 5. There was no significant difference in the mean graft flow and PI value between two groups.Conclusion: OPCAB can provide the same grafts flow and similar completeness of revascularization when compared with CCABG which indicates the similar anastomosis quality of grafts in OPCAB and CCABG groups.

  1. Current evidence of coronary artery bypass grafting off-pump versus on-pump: a systematic review with meta-analysis of over 16,900 patients investigated in randomized controlled trials†.

    Science.gov (United States)

    Deppe, Antje-Christin; Arbash, Wasim; Kuhn, Elmar W; Slottosch, Ingo; Scherner, Maximilian; Liakopoulos, Oliver J; Choi, Yeong-Hoon; Wahlers, Thorsten

    2016-04-01

    In the present systematic review with meta-analysis, we sought to determine the current strength of evidence for or against off-pump and on-pump coronary artery bypass grafting (CABG) with regard to hard clinical end-points, graft patency and cost-effectiveness. We performed a meta-analysis of only randomized controlled trials (RCT) which reported at least one of the desired end-points including: (i) major adverse cardiac and cerebrovascular events (MACCE), (ii) all-cause mortality, (iii) myocardial infarction, (iv) cerebrovascular accident, (v) repeat revascularization, (vi) graft patency and (vii) cost-effectiveness. The pooled treatment effects [odds ratio (OR) or weighted mean difference, 95% confidence intervals (95% CIs)] were assessed using a fixed or random effects model. A total of 16 904 patients from 51 studies were identified after literature search of the major databases using a predefined keyword list. The incidence of MACCE did not differ between the groups, neither during the first 30 days (OR: 0.93; 95% CI: 0.82-1.04) nor for the longest available follow-up (OR: 1.01; 95% CI: 0.92-1.12). While the incidence of mid-term graft failure (OR: 1.37; 95% CI: 1.09-1.72) and the need for repeat revascularization (OR: 1.55; 95% CI: 1.33-1.80) was increased after off-pump surgery, on-pump surgery was associated with an increased occurrence of stroke (OR: 0.74; 95% CI: 0.58-0.95), renal impairment (OR: 0.79; 95% CI: 0.71-0.89) and mediastinitis (OR: 0.44; 95% CI: 0.31-0.62). There was no difference with regard to hard clinical end-points between on- or off-pump surgery, including myocardial infarction or mortality. The present systematic review emphasizes that both off- and on-pump surgery provide excellent and comparable results in patients requiring surgical revascularization. The choice for either strategy should take into account the individual patient profile (comorbidities, life expectancy, etc.) and importantly, the surgeon's experience in performing on

  2. [Off-pump coronary revascularization. Late survival].

    Science.gov (United States)

    Espinoza, Juan; Camporrontondo, Mariano; Vrancic, Mariano; Piccinini, Fernando; Camou, Juan; Navia, Daniel

    2017-01-01

    Although randomized clinical trials have compared the short-term results of coronary revascularization with on-pump vs. off-pump, the long-term survival effect of off-pump coronary surgery has not been analyzed. The aim of this study was to compare the long-term survival of patients with coronary surgery with off-pump technique. All patients that underwent coronary revascularization from November 1996 to March 2015 were included (n = 4687). We analyzed the long-term survival and the incidence of cardiac events between patients who received off-pump coronary revascularization (n = 3402) against those revascularized with on-pump technique (n = 1285). The primary endpoint was defined as death from any cause. To reduce potential biases, risk-adjusted analysis was performed (propensity score). In-hospital mortality and during follow-up (10 years) for both groups were analyzed. The overall hospital mortality was 3.1%. A statistically significant difference between groups in favor of off-pump surgery was observed (2.3% vs. 5.2%, p < 0.0001). In the survival analysis, off-pump surgery proved to have similar long-term survival as on-pump surgery (off-pump vs. on-pump: 77.9% ± 1.2% vs. 80.2% ± 1.3%, p log rank = 0.361); even in the adjusted survival analysis (84.2% ± 2.9% vs. 80.3% ± 2.4%, p = 0.169). In conclusion, off-pump coronary surgery was associated with lower in-hospital mortality; and it was not associated with increased long-term survival compared with on-pump surgery.

  3. No major differences in 30-day outcomes in high-risk patients randomized to off-pump versus on-pump coronary bypass surgery: the best bypass surgery trial

    DEFF Research Database (Denmark)

    Møller, Christian H; Perko, Mario J; Lund, Jens T

    2010-01-01

    Off-pump coronary artery bypass grafting compared with coronary revascularization with cardiopulmonary bypass seems safe and results in about the same outcome in low-risk patients. Observational studies indicate that off-pump surgery may provide more benefit in high-risk patients. Our objective w...

  4. Estudo comparativo entre cirurgia de revascularização miocárdica com e sem circulação extracorpórea em mulheres Comparative study between on-pump and off-pump coronary artery bypass graft in women

    Directory of Open Access Journals (Sweden)

    Michel Pompeu Barros de Oliveira Sá

    2010-06-01

    Full Text Available INTRODUÇÃO: Tem sido bem documentado que mulheres têm taxas de morbimortalidade mais altas que homens submetidos à cirurgia de revascularização miocárdica (CRM. Em vista desta evidência, é necessário saber se há benefício da CRM sem circulação extracorpórea (CEC em comparação à CRM com CEC. OBJETIVOS: Comparar desfechos de morbimortalidade entre CRM sem CEC e CRM com CEC. MÉTODOS: Estudo retrospectivo. Nossa investigação analisa comparativamente o perfil clínico, 13 complicações relativas ao procedimento e mortalidade de uma população de 941 mulheres submetidas à CRM (549 sem CEC e 392 com CEC em dois hospitais, no período de janeiro de 2000 a dezembro de 2005. RESULTADOS: A taxa de mortalidade em mulheres submetidas à CRM sem CEC é menor que mulheres submetidas à CRM com CEC, entretanto, a diferença não é estatisticamente significativa (3,1% vs. 5,3%; P=0,134. As taxas de complicações analisadas (choque hemorrágico, neurológicas, respiratórias, insuficiência renal aguda, síndrome da angústia respiratória do adulto, septicemia, pneumonia, fibrilação atrial foram menores (diferença estatisticamente significativa em mulheres do grupo CRM sem CEC em comparação ao grupo CRM com CEC, com exceção das complicações baixo débito cardíaco e infecção de ferida operatória. CONCLUSÕES: As evidências sugerem que CRM sem CEC pode beneficiar as mulheres em comparação com CRM com CEC, pois parece reduzir as taxas de morbimortalidade. Dez das 13 complicações investigadas demonstraram uma significativa vantagem das mulheres submetidas à CRM sem CEC em relação àquelas submetidas à CRM com CEC.BACKGROUND: It has been well documented that women have higher morbidity and mortality rates than men following coronary artery bypass graft (CABG surgery. In view of this evidence, it is necessary to know if there is benefit to off-pump CABG surgery in women in comparison to on-pump CABG. OBJECTIVES: Compare

  5. The impact of avoiding cardiopulmonary by-pass during coronary artery bypass surgery in elderly patients: the Danish On-pump Off-pump Randomisation Study (DOORS)

    DEFF Research Database (Denmark)

    Houlind, Kim; Kjeldsen, Bo Juul; Madsen, Susanne Nørgaard;

    2009-01-01

    BACKGROUND: Coronary Artery Bypass Graft operation for ischemic heart disease provides improved quality of life and, in some patients, prolonged survival. Concern has, however, been raised about complications that may be related to the use of cardiopulmonary by-pass (CPB) and aortic cross-clampin...

  6. 老年女性患者体外循环和非体外循环下冠状动脉旁路移植术近远期预后对比%Comparative Study on Early and Long-term Outcomes Between On-pump and Off-pump Coronary Artery Bypass Grafting in Elder Female Patients

    Institute of Scientific and Technical Information of China (English)

    张继强; 张恒; 杜俊喆; 凤玮

    2015-01-01

    目的:比较老年女性患者在体外循环和非体外循环下冠状动脉旁路移植术(CABG)后的近远期临床预后。  方法:分析1999-01至2008-12于阜外医院接受单纯CABG的763例65岁以上老年女性患者的临床资料,根据手术方式,将患者分为体外循环下CABG组(体外循环组,n=331)和非体外循环下CABG组(非体外循环组,n=432),比较两组患者术后30天死亡率、住院期间的临床指标和术后远期的死亡率和主要不良心脑血管事件(MACCE事件:全因死亡、心肌梗死、脑卒中、二次再血管化)发生率。  结果:与体外循环组比较,非体外循环组患者年龄更大(P  结论:非体外循环CABG能降低老年女性患者的术后30天死亡率,同时能减少围术期血液制品的应用,缩短术后辅助通气时间,降低术后早期肾功能衰竭、肺部并发症和因出血再手术发生率。但不能降低远期死亡率和MACCE事件发生率。%Objective: To compare the early and long-term outcomes between on-pump and off-pump coronary artery bypass grafting (CABG) in elder female patients. Methods: A total of 763 female patients elder than 65 years of age received isolated CABG in our hospital from 1999-01 to 2008-12 were retrospectively studied. The patients were divided into 2 groups according to operational method: On-pump group,n=331 and Off-pump group,n=432. The mortality at 30 days post-operation, in-hospital clinical indexes and long term mortality with MACCE as all cause death, myocardial infarction (MI), stroke and repeated revascularization were compared between 2 groups. Results: Compared with On-pump group, the patients in Off-pump group had the elder age (P24h mechanical ventilation (P Conclusion: Off-pump CABG would reduce the mortality at 30 days post-operation, have less application of blood products, shorter post-operative mechanical ventilation, less early post-operative renal failure

  7. 体外循环及非体外循环冠状动脉旁路移植术后患者急性胃肠功能损伤的对比研究%Incidence of Acute Gastrointestinal Injury After On -pump and Off -pump Coronary Artery Bypass Surgery:A Comparative Study

    Institute of Scientific and Technical Information of China (English)

    吴昆鹏; 陈莹; 言彩红; 张凤文; 李方; 黄治家

    2015-01-01

    目的:比较体外循环及非体外循环冠状动脉旁路移植术后患者急性胃肠功能损伤的发生情况。方法回顾性分析2010年1月—2012年12月南华大学附属第二医院行冠状动脉旁路移植术治疗的冠心病患者536例,根据手术方式分为体外循环组412例,非体外循环组124例。观察两组患者一般情况、基础疾病、超声心动图结果、术后血流动力学、血管活性药物总量、日均尿量,术后急性胃肠功能损伤发生率及急性胃肠功能损伤分级。结果体外循环组与非体外循环组患者性别、年龄、体质量、纽约心脏病学会( NYHA )心功能分级、高血压发生率、糖尿病发生率、高脂血症发生率、慢性阻塞性肺疾病发生率、左心室舒张末期内径、左心室射血分数、术后日均心率、日均动脉压、日均中心静脉压、血管活性药物总量(去甲肾上腺素、多巴胺、多巴酚丁胺、肾上腺素)比较,差异均无统计学意义(P>0.05);体外循环组患者日均尿量较非体外循环组增多(P<0.05)。体外循环组22例(5.3%)发生急性胃肠功能损伤,其中Ⅰ级7例、Ⅱ级13例、Ⅲ级1例、Ⅳ级1例;非体外循环组6例(4.8%)发生急性胃肠功能损伤,均为Ⅰ级。两组患者急性胃肠功能损伤发生率比较,差异无统计学意义(χ2=0.048, P=0.519)。结论体外循环与非体外循环冠状动脉旁路移植术后患者急性胃肠功能损伤发生率无差异,但非体外循环冠状动脉旁路移植术后均为Ⅰ级。%Objective To compare the incidence of acute gastrointestinal injury ( AGI) after on -pump and off -pump coronary artery bypass surgery .Methods Conducted a retrospective analysis on 536 patients with coronary heart disease who received coronary artery bypass surgery in the Second Hospital Affiliated to South China University from January 2010 to December 2012.According to

  8. Qualidade de vida após revascularização cirúrgica do miocárdio com e sem circulação extracorpórea Quality of life after on-pump and off-pump coronary artery bypass grafting surgery

    Directory of Open Access Journals (Sweden)

    Celia R. S. R. Nogueira

    2008-10-01

    spent in the intensive care unit, and shorter hospital stays, thereby raising the perspective of improved quality of life (QOL for patients. OBJECTIVE: To assess quality of life in patients who underwent on-pump and off-pump CABG. METHODS: The Short-Form Health Survey (SF-36 Questionnaire was administered to patients with stable multivessel coronary artery disease (CAD and preserved ventricular function before and at six and 12 months after surgery. RESULTS: Between January 2002 and December 2006, a total of 202 patients were randomized to either on-pump or off-pump CABG. Demographic, clinical, laboratory, and angiographic characteristics were similar in both groups. One hundred and five patients underwent off-pump CABG and 97 underwent on-pump CABG. In the postoperative course, 22 patients had myocardial infarction, 29 reported angina, one was reoperated, and three experienced stroke. No patient died. Quality of life, as measured by the SF-36 questionnaire, was shown to be similar in both groups regarding physical and mental components. However, male patients showed a significant improvement in physical functioning and role limitations due to physical problems. Also, a large number of patients in both groups returned to work. CONCLUSION: Progressive enhancement in quality of life and early return to work were observed for all patients, regardless of the surgical technique used. Save for a greater improvement in physical functioning and role limitations due to physical problems experienced by male patients, no statistically significant differences were found in the other domains between groups.

  9. Off-pump versus on-pump coronary artery bypass surgery: meta-analysis and meta-regression of 13,524 patients from randomized trials Cirurgia de revascularização miocárdica com CEC versus sem CEC: meta-análise e meta-regressão de 13.524 pacientes de estudos randomizados

    Directory of Open Access Journals (Sweden)

    Michel Pompeu Barros de Oliveira Sá

    2012-12-01

    Full Text Available BACKGROUND: Most recent published meta-analysis of randomized controlled trials (RCTs showed that off-pump coronary artery bypass graft surgery (CABG reduces incidence of stroke by 30% compared with on-pump CABG, but showed no difference in other outcomes. New RCTs were published, indicating need of new meta-analysis to investigate pooled results adding these further studies. METHODS: MEDLINE, EMBASE, CENTRAL/CCTR, SciELO, LILACS, Google Scholar and reference lists of relevant articles were searched for RCTs that compared outcomes (30-day mortality for all-cause, myocardial infarction or stroke between off-pump versus on-pump CABG until May 2012. The principal summary measures were relative risk (RR with 95% Confidence Interval (CI and P values (considered statistically significant when INTRODUÇÃO: A meta-análise mais recente de estudos randomizados controlados (ERC mostrou que cirurgia de revascularização (CRM sem circulação extracorpórea (CEC reduz a incidência de acidente vascular cerebral em 30% em comparação com CRM com CEC, mas não mostrou diferença em outros resultados. Novos ERCs foram publicados, indicando necessidade de nova meta-análise para investigar resultados agrupados adicionando esses estudos. MÉTODOS: MEDLINE, EMBASE, CENTRAL / CCTR, SciELO, LILACS, Google Scholar e listas de referências de artigos relevantes foram pesquisados para ERCs que compararam os resultados de 30 dias (mortalidade por todas as causas, infarto do miocárdio ou acidente vascular cerebral - AVC entre CRM com CEC versus sem CEC até maio de 2012. As medidas sumárias principais foram o risco relativo (RR com intervalo de confiança de 95% (IC e os valores de P (considerado estatisticamente significativo quando <0,05. Os RR foram combinados entre os estudos usando modelo de efeito randômico de DerSimonian-Laird. Meta-análise e meta-regressão foram concluídas usando o software versão Meta-Análise Abrangente 2 (Biostat Inc., Englewood

  10. 非体外循环与常规体外循环下冠状动脉旁路移植术后肝肾功能的变化%Changes in liver and renal function following coronary artery bypass grafting:Off-pump versus on-pump

    Institute of Scientific and Technical Information of China (English)

    任崇雷; 高长青; 肖苍松; 吴扬; 邓学峰

    2008-01-01

    BACKGROUND:On-pump coronary artery bypass grafting(CABG)is replaced by off-pump coronary artery bypass grafting step by step.Effects of the two operations on liver and renal function deserve further studies.OBJECTIVE:To analyze the postoperative changes in liver and renal function between off-pump and on-pump CABG.DESIGN.TIME AND SETTING:Controlled study.The experiment was conducted at the Department of Cardiovascular Surgery.General Hospital of Chinese PLA.Beijing between June and November 2005.PARTICIPANTS:Fifty patients undergoing elective CABG at General hospital of PLA from June to November 2005 were enrolled in the study.All patients had normal liver and renal function before surgery.None of them developed severe acute liver and renal function.METHODS:All patients were allocated to either off-pump coronary bypass(OPCAB)(n=30)or on-pump conventional CABG (CCABG)(n=20)group according to patient's intention and condition.No significant difference was detected in age,gender,body mass index,preoperative ejection fraction,preoperative liver and renal function and operation risk factors between both groups(P>0.05).MAIN OUTCOME MEASURES:Alanine aminotransferase(ALT),aspartate aminotransferase(AST),blood urea nitrogen (BUN)and creatinine(Cr)were respectively measured in patients of both groups before surgery,1 day,1 week and 2 weeks after surgery.RESULTS:A total of 50 patients were involved in the final analysis.Changes in liver function:Serum ALT and AST Ievels in the OPCAB group were significantly lower than those in the CCABG group at 1 day after surgery(P0.05).主要观察指标:两组患者分别于术前及术后1 d.1及2周抽血测定血丙氨酸氨基转移酶,天冬氨酸转氨酶,尿素氮及肌酐值评价患者肝肾功能.结果:纳入患者50例患者均进入结果分析.[1]肝功能变化:非体外循环下冠状动脉旁路移植术组患者术后第1天血丙氨酸氨基转移酶及天冬氨酸转氨酶明显低于体外循环下冠状动脉旁路

  11. Activation of hemostasis after off-pump coronary artery bypass graft surgery

    NARCIS (Netherlands)

    Lo, B.

    2007-01-01

    The aim of this thesis was to study the activation of hemostasis and inflammation, in patients undergoing off-pump (OPCAB) and on-pump coronary artery bypass graft (CABG) surgery and the relationship of coagulation and inflammation to clinical outcome. We hypothesized that activation of hemostasis a

  12. Fluxometria da artéria torácica interna esquerda na revascularização da artéria descendente anterior com e sem circulação extracorpórea Flowmetry of left internal thoracic artery graft to left anterior descending artery: comparison between on-pump and off-pump surgery

    Directory of Open Access Journals (Sweden)

    Filinto Marques de Cerqueira Neto

    2012-06-01

    Full Text Available INTRODUÇÃO: A cirurgia de revascularização do miocárdio (RM sem circulação extracorpórea (CEC é uma técnica amplamente utilizada. A fluxometria coronariana é a técnica mais usada para avaliação dos enxertos, porém, poucos estudos comparam os dados fluxométricos na RM com e sem CEC. O objetivo deste estudo foi comparar as variáveis fluxométricas dos enxertos de artéria torácica interna esquerda para a artéria descendente anterior em pacientes submetidos à RM com e sem CEC. MÉTODOS: Entre março e setembro de 2010, foram analisados retrospectivamente 35 pacientes consecutivos, não randomizados, submetidos à RM. Foram alocados 10 pacientes no grupo A (com CEC e 25 no grupo B (sem CEC. O fluxo médio do enxerto (FME, o índice pulsátil (PI e a porcentagem de enchimento diastólico (ED foram obtidos por meio da fluxometria por tempo de trânsito. Foi utilizado o teste exato de Fisher e Mann-Whitney, sendo considerado estatisticamente significante PBACKGROUND: Off-pump coronary bypass grafting (OPCAB has become a widely used technique. Coronary flowmetry is the most common method employed to assess graft patency, nevertheless, few studies compare flow patterns between ONCAB and OPCAB surgery. The objective of this study was to compare flowmetry data in left internal mammary artery grafts bypasses to the left anterior descendent artery. METHODS: From March to September of 2010, thirtyfive consecutive, non-randomized patients underwent CABG and were retrospectively evaluated. Ten patients were located on group A (On Pump, and twenty-five on group B (Off Pump. The mean graft flow (MGF, pulsatile index (PI and diastolic filling (DF were obtained using Transit Time Flowmetry (TTFM. The Fisher exact test, and Mann Whitney test were used, and a P value of < 0.05 was considered to indicate statistical significance. RESULTS: There were no deaths, AMI, re-interventions or PTCA in a 30-day period. The number of bypasses performed per

  13. Graft patency after off-pump coronary artery bypass surgery is inferior even with identical heparinization protocols

    DEFF Research Database (Denmark)

    Houlind, Kim; Fenger-Grøn, Morten; Holme, Susanne J;

    2014-01-01

    OBJECTIVE: To determine whether graft patency after on-pump and off-pump coronary artery bypass surgery is similar when performed using the same heparinization protocol. METHODS: In a randomized, controlled, multicenter trial, 900 patients more than 70 years of age received either on-pump or off-...

  14. Emergency off-pump coronary artery surgery

    Institute of Scientific and Technical Information of China (English)

    Shahzad G Raja; Zulfiqar Haider; Haider Zaman

    2004-01-01

    Background Off-pump coronary artery bypass grafting is fast-becoming a procedure of choice for elective revascularization in high-risk patients with multi-vessel coronary artery disease. However, the role of off-pump coronary artery bypass grafting for patients with acute coronary syndromes requiring emergency revascularization still requires validation. We present our experience to show the feasibility of off-pump coronary artery surgery as an emergency revascularization technique. Methods From April 2001 to September 2003, emergency (operation within 24 hours after hospitalization) coronary artery bypass grafting without cardiopulmonary bypass (CPB) was performed in 66 patients with a mean age of (66.9±5.4) years (range 49-72 years). They presented acute coronary syndromes with 38 patients on platelet glycoprotein Ⅱb/Ⅲa receptor antagonists. All patients underwent off-pump coronary artery bypass surgery via sternotomy with the intention of complete coronary revascularization.Results An average of 2.9 grafts per patient were performed and the posterior descending artery and marginal branches of the circumflex artery were grafted in 83.3% of the patients. There were 4 events of intraoperative cardiac instability, precipitated by occlusion of right coronary artery or positioning of a cardiomegaly heart, leading to immediate conversion to CPB. The mortality rate was 3% (2/66). Two patients suffered postoperative stroke while three needed hemofiltration for acute renal failure. Post surgery elective coronary angiography (n=46) showed no significant stenosis.Conclusion Emergency off-pump coronary artery surgery with complete revascularization is feasible in patients with acute coronary syndrome with low morbidity and mortality and excellent early results.

  15. Graft patency after off-pump coronary artery bypass surgery is inferior even with identical heparinization protocols

    DEFF Research Database (Denmark)

    Houlind, Kim; Fenger-Grøn, Morten; Holme, Susanne J.

    2014-01-01

    OBJECTIVE: To determine whether graft patency after on-pump and off-pump coronary artery bypass surgery is similar when performed using the same heparinization protocol. METHODS: In a randomized, controlled, multicenter trial, 900 patients more than 70 years of age received either on-pump or off-...... not increase the risk of stenosis of the coronary artery distal to the anastomosis. CONCLUSIONS: Despite comparable heparinization, graft patency after off-pump surgery was inferior to that after on-pump surgery.......OBJECTIVE: To determine whether graft patency after on-pump and off-pump coronary artery bypass surgery is similar when performed using the same heparinization protocol. METHODS: In a randomized, controlled, multicenter trial, 900 patients more than 70 years of age received either on-pump or off......-pump coronary artery bypass surgery. Heparin was given to achieve an activated clotting time of 400 seconds before arteriotomy in both groups. After the procedure, protamine sulfate was given to revert the activated clotting time to less than 120 seconds. Coronary angiography was performed 6 months after...

  16. Does Off-Pump Coronary Artery Bypass Grafting Negatively Impact Long-Term Survival and Freedom from Reintervention?

    Directory of Open Access Journals (Sweden)

    Shahzad G. Raja

    2013-01-01

    Full Text Available Recently published evidence has raised concerns about worse late mortality and increasing need for reintervention after off-pump coronary artery bypass grafting. We undertook this study to assess the impact of off-pump coronary artery bypass grafting on survival and freedom from reintervention at 10 years. From January 2002 to December 2002, 307 consecutive patients who had isolated multivessel off-pump coronary artery bypass grafting at our institution were compared to a control group of 397 patients that underwent multivessel on-pump coronary artery bypass grafting during the same period. In addition, univariate and risk-adjusted comparisons between the two groups were performed at 10 years. Kaplan-Meier survival was similar for the two cohorts. After adjusting for clinical covariates, off-pump coronary artery bypass grafting did not emerge as a significant independent predictor of long-term mortality (Hazard Ratio 0.91; 95% Confidence Interval 0.70–1.12, readmission to hospital for cardiac cause (Hazard Ratio 0.96; 95% Confidence Interval 0.78–1.10, or the need for reintervention (Hazard Ratio 0.93; 95% Confidence Interval 0.87–1.05. Off-pump coronary artery bypass grafting compared with on-pump coronary artery bypass grafting does not adversely impact survival or freedom from reintervention at a 10-year follow-up.

  17. Anesthesia for off-pump coronary artery bypass surgery

    Directory of Open Access Journals (Sweden)

    Thomas M Hemmerling

    2013-01-01

    Full Text Available The evolution of techniques and knowledge of beating heart surgery has led anesthesia toward the development of new procedures and innovations to promote patient safety and ensure high standards of care. Off-pump coronary artery bypass (OPCAB surgery has shown to have some advantages compared to on-pump cardiac surgery, particularly the reduction of postoperative complications including systemic inflammation, myocardial injury, and cerebral injury. Minimally invasive surgery for single vessel OPCAB through a limited thoracotomy incision can offer the advantage of further reduction of complications. The anesthesiologist has to deal with different issues, including hemodynamic instability and myocardial ischemia during aorto-coronary bypass grafting. The anesthesiologist and surgeon should collaborate and plan the best perioperative strategy to provide optimal care and ensure a rapid and complete recovery. The use of high thoracic epidural analgesia and fast-track anesthesia offers particular benefits in beating heart surgery. The excellent analgesia, the ability to reduce myocardial oxygen consumption, and the good hemodynamic stability make high thoracic epidural analgesia an interesting technique. New scenarios are entering in cardiac anesthesia: ultra-fast-track anesthesia with extubation in the operating room and awake surgery tend to be less invasive, but can only be performed on selected patients.

  18. Off-Pump Coronary Bypass Grafting Causing Stunned Myocardium

    Directory of Open Access Journals (Sweden)

    Feridoun Sabzi

    2015-10-01

    Full Text Available The term “stunned myocardium” refers to abnormalities in the myocardial function following reperfusion and is common in on-pump coronary artery bypass grafting (CABG and is exceedingly rare in off- pump CABG. A 53-year-old man presented with unstable angina due to the severe stenosis of the left anterior descending coronary artery (LAD and the obtuse marginal. Laboratory findings and Chest X-ray revealed nothing abnormal. The intraoperative course was uneventful. The patient left the operating room without any inotropic support. Six hours later, however, he developed low cardiac output .At exploration, cardiac tamponade was excluded and flowmetry showed that the graft had adequate function. Cardiac enzymes were normal. High-dose adrenalin and Dobutamine were administrated and an intra-aortic balloon pump was used. After hemodynamic stabilization, the patient left the Intensive Care Unit without an intra-aortic balloon pump and inotropic support. On the fifth postoperative day, coronary angiography showed patent grafts and correct anastomotic sites. On the seventh postoperative day, the akinetic lateral wall of the left ventricle changed to dyskinesia. Finally after hospital discharge on the thirtieth postoperative day, an echocardiogram showed normal left ventricular function without regional wall motion abnormalities

  19. Cardiac luxation to facilitate off-pump bilateral lung transplantation

    NARCIS (Netherlands)

    Visser, Hester T.; Erasmus, Michiel E.; Ebels, Tjark

    To facilitate access to the left hilum during off-pump bilateral lung transplantation we used the Xpose 4 (TM) apical suction device (Guidant Corp., Indianapolis, IN), an off-pump coronary bypass device to luxate the heart out of the pericardium. The effects on circulation and possible myocardial

  20. Cardiovascular function during the first 24 hours after off pump coronary artery bypass grafting--a prospective, randomized study.

    Science.gov (United States)

    Vedin, Jenny; Jensen, Ulf; Ericsson, Anders; Bitkover, Catarina; Samuelsson, Sten; Bredin, Fredrik; Vaage, Jarle

    2003-12-01

    We hypothesized that cardiovascular performance during the first 24 postoperative hours would be better in patients after off pump coronary artery bypass grafting compared to conventional on pump surgery. Fifty-nine patients were randomized to on or off pump coronary artery bypass grafting. Hemodynamic parameters, including cardiac index and systemic vascular resistance index were measured before and at 1, 4, and 20 h after surgery. Troponin T and creatine kinase-MB (CK-MB) were measured before and at 1, 6, and 20 h after surgery. There was no difference in age, sex, ejection fraction or number of grafts between groups. Cardiac index was higher (p=0.05) and systemic vascular resistance index was lower (p=0.007) in the off pump group 1 h after arrival in the intensive care unit. CK-MB and troponin T were significantly lower in the off pump group after 1 h (CK-MB p<0.001, troponin T p<0.001) and after 6 h (CK-MB p=0.02, troponin T p<0.001). After 24 h there was no difference between the two groups. In conclusion, immediately after surgery there was better cardiovascular performance and less release of markers of myocardial damage after off pump coronary surgery. After 24 h all differences were eliminated.

  1. Off-Pump Complete Coronary Revascularization with 860 Cases and Two Year Experience

    Institute of Scientific and Technical Information of China (English)

    谢斌; 张镜芳; Pravin Kuma; Devi Prasad Shetty

    2002-01-01

    Background Cardiopulmonary bypass (CPB) produces a well-documented diffuse inflammatory response that affects multiple organ systems. To avoid the deleterious effects of cardiopulmonary bypass, off-pump coronary artery bypass grafting is becoming increasingly popular world- wide.We reviewed our experience of complete coronary artery revascularization on the beating heart without CPB.Methods From Aug 1998 to Aug 2000, 860off-pump revascularizations (99 % since January 1999) were performed at Manipal Hospital Heart Foundation. The patients consist of males 757(88%), females 103(12%) . Averaged age 64. 2±15years. All surgeries were performed through a median sternotomy. Exposure techniques are tailored to individual vessels and cardiac regions. Local immobilization is performed with octopus. Vascular control is achieved with occluders and shunts. Results Among 860 off-pump CABG patients. Single graft 72(8.3 % ), two grafts 208 (24. 2 % ), three grafts 469(54.5 % ), four grafts 101 (11.8 % ), five graft 10(1.2 % ) . The average number of grafts per patient was 2.72 ±0. 32. Operative mortality was 0.69 % (6patients). Anesthetic time 3.9 + 1.2hours, extubation time 6 ± 2. 5 hours, Blood requirement 360 ±90 ml,Preoperative LVEF 60.2 + 8.5 %, Post LVEF 64. 1 +14 % Low cardiac output 48 patients (5.6 % ), IABP requirement: 25 patients(2.9 %), 25 patients converted to CPB during OP-CAB (2.9 % ) and 20 of them were done with on pump beating heart. 25 patientsshowed myocardial ischemic and 16 patients showed perioperative myocardial infarction. ICU stay 1. 1 ± 0.8days, hospital stay 6.2±1.1 days. Conclusion Off-pump coronary artery bypass in complete revas cularization is a safe, effective technique and suitable.

  2. Surgical phantom for off-pump mitral valve replacement

    Science.gov (United States)

    McLeod, A. Jonathan; Moore, John; Guiraudon, Gerard M.; Jones, Doug L.; Campbell, Gordon; Peters, Terry M.

    2011-03-01

    Off-pump, intracardiac, beating heart surgery has the potential to improve patient outcomes by eliminating the need for cardiopulmonary bypass and aortic cross clamping but it requires extensive image guidance as well as the development of specialized instrumentation. Previously, developments in image guidance and instrumentation were validated on either a static phantom or in vivo through porcine models. This paper describes the design and development of a surgical phantom for simulating off-pump mitral valve replacement inside the closed beating heart. The phantom allows surgical access to the mitral annulus while mimicking the pressure inside the beating heart. An image guidance system using tracked ultrasound, magnetic instrument tracking and preoperative models previously developed for off-pump mitral valve replacement is applied to the phantom. Pressure measurements and ultrasound images confirm the phantom closely mimics conditions inside the beating heart.

  3. Off-pump supra-arterial myotomy for myocardial bridging.

    Science.gov (United States)

    Crespo, Alejandro; Aramendi, José I; Hamzeh, Gadah; Voces, Roberto

    2008-09-01

    We report the results of surgery and midterm outcome in two patients with symptomatic myocardial bridging who underwent off-pump supra-arterial myotomy. Both patients were operated upon through a median sternotomy. The anterior wall of the heart was exposed in the same manner as in off-pump CABG. The left anterior descending coronary artery is unroofed from its myocardial bridge with the aid of a heart stabilizer and a blower. Neither heparin nor blood transfusion was required. Both patients survived the operation and are asymptomatic. Postoperative coronary angiogram showed good resolution of the muscle bridge in one patient. We conclude that in symptomatic patients with myocardial bridging despite medical therapy, surgical myotomy can be considered an adequate therapy. It can be safely done off-pump.

  4. Extracardiac off-pump fontan completion for single ventricle with dextrocardia.

    Science.gov (United States)

    Goksel, Onur S; Gok, Emre; Tireli, Emin; Dayioglu, Enver

    2013-01-01

    Extracardiac off-pump is reported to result in better early hemodynamics and shorter mechanical ventilation periods. We present a case report of extracardiac off-pump Fontan in a 5-year-old girl with single ventricle and dextrocardia.

  5. Off-pump bidirectional Glenn through right anterior thoracotomy

    Directory of Open Access Journals (Sweden)

    Maximo Guida

    2015-08-01

    Full Text Available Abstract The Glenn operation involving anastomosis of the superior vena cava to the pulmonary artery has been performed for palliative operations of many cyanotic congenital heart diseases in addition to the single ventricle since the 1960s. The classic procedure is done via median sternotomy and cardiopulmonary bypass. The benefits of this procedure without the use of cardiopulmonary bypass remain mixed within reported series. Cases using this approach and off-pump technique together in Latin-America have not yet been reported in the scientific literature.

  6. Off-pump coronary artery bypass grafting in patients with mirror-imaging dextrocardia.

    Science.gov (United States)

    Yuan, Xin; Sun, Hansong; Wang, Xianqiang

    2015-08-01

    Dextrocardia requires alterations in techniques during coronary artery bypass graft (CABG) surgery. We report two cases undergoing off-pump coronary artery bypass graft (OPCAB) surgery and discuss techniques for the operative management of these patients.

  7. Oxygenation and release of inflammatory mediators after off-pump compared with after on-pump coronary artery bypass surgery

    DEFF Research Database (Denmark)

    Rasmussen, B.S.; Laugesen, Helle; Sollid, J.

    2007-01-01

    the use of CPB (OPCAB) would affect post-operative oxygenation and release of inflammatory mediators less compared with CABG. Methods: Low-risk patients scheduled for elective coronary revascularization were randomly assigned to one of two groups (CABG, n = 17 or OPCAB, n = 18). Two parameters...... of oxygenation, shunt (%) and ventilation-perfusions mismatch, described as ΔPO2 (kPa), were estimated for up to 5 days post-operatively. Systemic release of interleukin (IL)-6, -8 and -10, C-reactive protein (CRP) and neutrophils were measured in peripheral blood samples for up to 3 days post......-operatively. The lungs participation in the cytokine response was evaluated from mixed venous blood samples taken within the first 16 h post-operatively. Results: OPCAB was followed by a higher shunt (P = 0.047), with no difference (P = 0.47) in the deterioration of ΔPO2 between the groups. OPCAB was followed...

  8. Off-pump coronary artery bypass in poland syndrome with dextrocardia: case report

    Directory of Open Access Journals (Sweden)

    More Ranjit

    2011-05-01

    Full Text Available Abstract Poland Syndrome is a congenital disorder characterised by hypoplasia of the pectoral muscles along with upper extremity deformities. We encountered a patient with Poland syndrome associated with dextrocardia and also failed pectus excavatum repairs who presented to us with symptomatic ischaemic heart disease requiring intervention. He underwent successful off-pump coronary artery bypass surgery (OPCABG. As far as we are aware, this is the first case report of OPCABG in a case of Poland syndrome with dextrocardia. We describe here the management of this complex patient and wish to emphasise that the off-pump option is feasible in dextrocardia with some technical modifications.

  9. Operative strategies to reduce cerebral embolic events during on- and off-pump coronary artery bypass surgery: A stratified, prospective randomized trial.

    Science.gov (United States)

    Halkos, Michael E; Anderson, Aaron; Binongo, Jose Nilo G; Stringer, Anthony; Lasanajak, Yi; Thourani, Vinod H; Lattouf, Omar M; Guyton, Robert A; Baio, Kim T; Sarin, Eric; Keeling, William B; Cook, N Renee; Carssow, Katherine; Neill, Alexis; Glas, Kathryn E; Puskas, John D

    2017-10-01

    To determine the impact of different aortic clamping strategies on the incidence of cerebral embolic events during coronary artery bypass grafting (CABG). Between 2012 and 2015, 142 patients with low-grade aortic disease (epiaortic ultrasound grade I/II) undergoing primary isolated CABG were studied. Those undergoing off-pump CABG were randomized to a partial clamp (n = 36) or clampless facilitating device (CFD; n = 36) strategy. Those undergoing on-pump CABG were randomized to a single-clamp (n = 34) or double-clamp (n = 36) strategy. Transcranial Doppler ultrasonography (TCD) was performed to identify high-intensity transient signals (HITS) in the middle cerebral arteries during periods of aortic manipulation. Neurocognitive testing was performed at baseline and 30-days postoperatively. The primary endpoint was total number of HITS detected by TCD. Groups were compared using the Mann-Whitney U test. In the off-pump group, the median number of total HITS were higher in the CFD subgroup (30.0; interquartile range [IQR], 22-43) compared with the partial clamp subgroup (7.0; IQR, 0-16; P 1 CFD (12.5 [IQR, 4-19] vs 36.0 [IQR, 25-47]; P = .001). In the on-pump group, the median number of total HITS was 10.0 (IQR, 3-17) in the single-clamp group, compared with 16.0 (IQR, 4-49) in the double-clamp group (P = .10). There were no differences in neurocognitive outcomes across the groups. For patients with low-grade aortic disease, the use of CFDs was associated with an increased rate of cerebral embolic events compared with partial clamping during off-pump CABG. A single-clamp strategy during on-pump CABG did not significantly reduce embolic events compared with a double-clamp strategy. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  10. Off pump coronary artery bypass surgery for significant left ventricular dysfunction: safety, feasibility, and trends in methodology over time—an early experience

    Science.gov (United States)

    Sharoni, E; Song, H K; Peterson, R J; Guyton, R A; Puskas, J D

    2006-01-01

    Objective To examine the safety and applicability of off pump coronary artery bypass surgery (OPCAB) in patients with significant left ventricular dysfunction and to discuss the clinical implications for the surgical methods. Design Retrospective study. Setting Tertiary care university affiliated referral centre. Participants 353 consecutive patients with preoperative left ventricular ejection fraction ⩽ 35% who underwent coronary artery bypass over a three year period. Main outcome measures Postoperative morbidity and mortality. Methods 144 patients operated by OPCAB were compared with 209 patients operated by conventional coronary artery bypass. Multivariate and univariate analyses were performed on the pre‐ and postoperative variables to predict risk factors associated with hospital morbidity and mortality. Results Patients in the OPCAB group were more likely to be women and to have congestive heart failure, chronic obstructive pulmonary disease, hypertension, and diabetes; patients in the on pump group were more likely to have had a recent myocardial infarction and to have more severe angina pectoris and an urgent/emergent status. The groups did not differ significantly in length of stay, major postoperative complication rates, or mortality. Comparison of the impact of the procedures on surgical methods over time showed an increase in the use of OPCAB (13% to 67%), without any impact on morbidity or mortality. Conclusions OPCAB is feasible and applicable for patients with depressed left ventricular function. This high risk group can potentially benefit from the off pump approach. PMID:15994913

  11. Off-pump Y-graft coronary artery bypass in a patient with situs inversus totalis

    NARCIS (Netherlands)

    Arrigoni, Sara Camilla; Oosterhof, Richard; Mariani, Massimo Alessandro

    2010-01-01

    Situs inversus is the mirror image of situs solitus. Situs inversus with dextrocardia is termed 'situs inversus totalis'. Since situs inversus totalis is a rare condition, there are a only a few reports about off-pump coronary artery bypass (OPCAB) in these patients. A 67-year-old man with a diagnos

  12. A new beating-heart off-pump coronary artery bypass grafting training model

    NARCIS (Netherlands)

    Bouma, Wobbe; Kuijpers, Michiel; Bijleveld, Aanke; De Maat, Gijs E.; Koene, Bart M.; Erasmus, Michiel E.; Natour, Ehsan; Mariani, Massimo A.

    OBJECTIVES: Training models are essential in mastering the skills required for off-pump coronary artery bypass grafting (OPCAB). We describe a new, high-fidelity, effective and reproducible beating-heart OPCAB training model in human cadavers. METHODS: Human cadavers were embalmed according to the

  13. Ischemia monitoring in off-pump coronary artery bypass surgery using intravascular near-infrared spectroscopy

    Directory of Open Access Journals (Sweden)

    Zerkowski Hans-Reinhard

    2006-05-01

    Full Text Available Abstract Background In off-pump coronary artery bypass surgery, manipulations on the beating heart can lead to transient interruptions of myocardial oxygen supply, which can generate an accumulation of oxygen-dependent metabolites in coronary venous blood. The objective of this study was to evaluate the reliability of intravascular near-infrared spectroscopy as a monitoring method to detect possible ischemic events in off-pump coronary artery bypass procedures. Methods In 15 elective patients undergoing off-pump myocardial revascularization, intravascular near-infrared spectroscopic analysis of coronary venous blood was performed. NIR signals were transferred through a fiberoptic catheter for signal emission and collection. For data analysis and processing, a miniature spectrophotometer with multivariate statistical package was used. Signal acquisition and analysis were performed before and after revascularization. Spectroscopic data were compared with hemodynamic parameters, electrocardiogram, transesophageal echocardiography and laboratory findings. Results A conversion to extracorporeal circulation was not necessary. The mean number of grafts per patient was 3.1 ± 0.6. An intraoperative myocardial ischemia was not evident, as indicated by electrocardiogram and transesophageal echocardiography. Continuous spectroscopic analysis showed reproducible absorption spectra of coronary sinus blood. Due to uneventful intraoperative courses, clear ischemia-related changes could be detected in none of the patients. Conclusion Our initial results show that intravascular near-infrared spectroscopy can reliably be used for an online intraoperative ischemia monitoring in off-pump coronary artery bypass surgery. However, the method has to be further evaluated and standardized to determine the role of spectroscopy in off-pump coronary artery bypass surgery.

  14. Off-Pump CABG in a Patient with Dextrocardia Totalis: A Case Report

    Directory of Open Access Journals (Sweden)

    Ali Dabbagh

    2011-09-01

    Full Text Available Coronary revascularization in patients with dextrocardia is not a common clinical condition. There are very few cases of off-pump coronary artery bypass. A 64-year-old woman was admitted to a university hospital due to exertional chest pain. Her primary diagnosis was coronary artery disease superimposed on dextrocardia, which was first suspected on physical examination, with the patient having right-sided heart sounds on auscultation. It was corroborated by chest X-ray. After diagnostic evaluations, including coronary angiography, she underwent off-pump coronary artery bypass grafting due to a significant left main coronary artery stenosis associated with dextrocardia. Two years later, multi-slice CT angiography revealed patent grafts, demonstrating good clinical results.

  15. Off-Pump CABG in a Patient with Dextrocardia Totalis: a Case Report.

    Science.gov (United States)

    Dabbagh, Ali; Bolourian, Ali Asghar

    2011-01-01

    Coronary revascularization in patients with dextrocardia is not a common clinical condition. There are very few cases of off-pump coronary artery bypass. A 64-year-old woman was admitted to a university hospital due to exertional chest pain. Her primary diagnosis was coronary artery disease superimposed on dextrocardia, which was first suspected on physical examination, with the patient having right-sided heart sounds on auscultation. It was corroborated by chest X-ray. After diagnostic evaluations, including coronary angiography, she underwent off-pump coronary artery bypass grafting due to a significant left main coronary artery stenosis associated with dextrocardia. Two years later, multi-slice CT angiography revealed patent grafts, demonstrating good clinical results.

  16. Coronary air embolism in off-pump surgery caused by blower-mister device.

    Science.gov (United States)

    Korkmaz, Askin Ali; Guden, Mustafa; Korkmaz, Feride; Yuce, Murat

    2008-01-01

    Gaseous emboli caused by the blower-mister result in air locks within coronary vessels. We describe the case of a coronary air embolism caused by a blower-mister device on off-pump surgery. The tip of the device unexpectedly entered the coronary artery through arteriotomy and caused the air emboli. Air locks in the coronary circulation led to hemodynamic deterioration, and cardiopulmonary bypass was started following the emergency cannulation.

  17. Rare case-series of electrocautery burn following off-pump coronary artery bypass grafting

    Science.gov (United States)

    Sabzi, Feridoun; Niazi, Mojtaba; Ahmadi, Alireza

    2014-01-01

    Abstract: With an increasing number of off-pump coronary artery surgery procedures in high-risk patients with coagulopathy, including renal failure, hepatic failure and anticoagulant drug-using patients, the frequency of related complications such as repeated exploration for bleeding is also increasing. The associated co-morbidity and repeated use of electrocautery in postoperative bleeding leaves patients susceptible to electrocautery ulcers. In this case series, rare cases of cautery burn with unique causative mechanisms are described. PMID:23669602

  18. Off-pump myocardial revascularization using the octopus tissue stabilizer system

    Directory of Open Access Journals (Sweden)

    Milojević Predrag S.

    2003-01-01

    Full Text Available Off-pump coronary artery bypass surgery (OPCAB has changed the approach to contemporary coronary surgery. Development of new surgical devices and techniques has reduced morbidity and mortality during off-pump surgery. From March 2000 - April 2002, a total of 136 patients underwent open heart surgery using off-pump technique and fast-track anesthesia at Dedinje Cardiovascular Institute. Octopus Medtronic coronary stabilizer was used for stabilization of targeted vessel. Arterial grafts were used 169 times and saphenous vein 69 times. Average number of anastomoses was 1,830,73 per patient. One patient (0.74% died. Three patients (2.21% underwent surgery revision due to postoperative bleeding and one (0.74% because of graft dysfunction Perioperative myocardial infarction was registered 2 times (1.47% pneumothorax 3 times (2.21%, postoperative arrhythmias 11 times (8.09% transitory ischemic attack once (0.74% and deep wound infection once (0.74%. Twelve patients (8.82% required prolonged inotropic support Angiographies early revealed patent grafts in 8 patients (5.88%. OPCAB is a safe and effective alternative approach to coronary artery revascularization Use of coronary stabilizer has improved the safety and quality of OPCAB surgery.

  19. The real-world outcomes of off-pump coronary artery bypass surgery in a public health care system

    Science.gov (United States)

    Guru, Veena; Glasgow, Kevin W; Fremes, Stephen E; Austin, Peter C; Teoh, Kevin; Tu, Jack V

    2007-01-01

    BACKGROUND: The population-based results of off-pump coronary artery bypass surgery (OPCAB) in a public health care system have not been reported. OBJECTIVE: The study objective was to compare the one-year outcomes of OPCAB with those of the standard on-pump coronary artery bypass surgery (ONCAB) in the province of Ontario. METHODS: The present study was a retrospective, population-based study (n=15,172, with 1660 OPCAB patients) undertaken in fiscal years 2000 and 2001 using clinical and administrative data. Multivariate regression modelling for risk adjustment and propensity matching were used to compare OPCAB with ONCAB for one-year outcomes, including death, repeat revascularization and cardiac readmission. RESULTS: The rate of OPCAB was 11%, with institutional rates ranging from 3% to 51%. OPCAB patients were more likely to be female and older than 79 years of age, with peripheral vascular disease and higher socioeconomic status. OPCAB patients were less likely to have surgically significant coronary disease, poor left ventricular function, an urgent status, congestive heart failure and diabetes. The risk-adjusted one-year composite outcome was higher for OPCAB (11.8%, 95% CI 10.40% to 13.29%) than ONCAB (10.8%, 95% CI 10.23% to 11.27%); however, this difference was eliminated with propensity matching. OPCAB patients had shorter hospital lengths of stay and lower blood product transfusion rates than ONCAB patients. CONCLUSIONS: Despite the minimal use of OPCAB in Canada’s public health care system, outcome rates are similar to those of ONCAB. The benefits of OPCAB observed in randomized trials, including shorter hospital lengths of stay and lower transfusion rates, remained true in the investigators’ real-world experience. The results OPCAB were at least equivalent to those of ONCAB. PMID:17380221

  20. Off-pump Coronary Endarterectomy and Bypass Grafting in Patients With Diffuse Coronary Artery Disease

    Institute of Scientific and Technical Information of China (English)

    Chen Xin; Xu Ming; Jiang Yinshuo; Sui Kaihu; Qiu Zhibing; Wang Liming; Liu Peisheng

    2006-01-01

    Objectives To summarize our preliminary experience on off-pump coronary endarterectomy and bypass grafting in patients with diffuse coronary artery disease. Methods Over a 3-year period, 53 patients (41 male) with diffuse coronary artery disease underwent off-pump coronary endarterectomy and bypass grafting at our institution.Patients' age ranged from 55 to 79 years. Prior to surgery, 70% of patients were in CCS angina class 2 (n=5) or 3 (n=32), and nearly half of them (26/53) had history of myocardial infarction. Most patients (n=50) had triple vessel lesions, with left main stem involvement in 9. Their left ventricular ejection fraction ranged from 26% to 65% (mean 52%). At the end of operation, a flow-meter was routinely applied to measure the perfusion flow of each postendarterectomy graft. Results In total, 70 endarterectomies were performed in 53 patients, including 38 in left anterior descending artery (LAD), 8 in circumflex artery and 24 in right coronary artery. Four operations were emergency or urgent in nature. Five patients received on-lay venous patch after endarterectomy in LAD, followed by left internal mammary artery (LIMA) grafting on the patch. The graft conduits included 53 LIMAs and 2 radial arteries,and saphenous veins in others. Mean number of grafts per patient was 3.75. The overall index of completeness of revascularization reached 1.03±0.07. There was no death in this group of patients during their post-operative hospital stay (mean duration = 9 days).Intra-operatively, 63 (90%) out of the 70 grafts after coronary endarterectomy showed satisfactory flow. Two patients had perioperative myocardial infarctions but neither experienced significant hemodynamic deteriations. Conclusions Off-pump coronary endarterectomy with bypass grafting is technically feasible and can be performed safely in patients with diffuse coronary artery disease. This strategy may help to improve the completeness of myocardial revascularization.

  1. Repair of left ventricular aneurysm during off-pump coronary artery bypass surgery

    Institute of Scientific and Technical Information of China (English)

    YU Yang; GU Cheng-xiong; WEI Hua; LIU Rui; CHEN Chang-cheng; FANG Ying

    2005-01-01

    Background Acute myocardial infarction can result in left ventricular aneurysm, which may in turn cause congestive heart failure, ventricular arrhythmia and thromboembolic events. This study evaluates results achieved with a modified linear closure of left ventricular aneurysms during off-pump coronary artery bypass surgery.Methods From January 2001 to May 2004, 75 patients were operated on for nonruptured, postinfarctional, left ventricular aneurysm during off-pump coronary artery bypass surgery. Repair was completed on the beating heart to minimize ischaemia and allow assessment of wall function and viability to guide closure. All patients presented with symptoms of angina and congestive heart failure or ventricular arrhythmia. The majority (75%) of the patients were in NYHA functional class Ⅲ or Ⅳ. Preoperative ejection fraction was 26%±9%. The mean left ventricular, end diastolic diameter was (57.5±7.1) mm. The ventricular preoperative and postoperative performances were compared. χ2 test and Student's t test were used to analyse the outcomes. A P value less than 0.05 was considered significant.Results Hospital mortality was 1.3% (1/75). Coronary artery bypass was performed with an average of (3.3±1.2) grafts per patient. At the time of followup, all the patients had no symptoms. The mean NYHA class and ejection fraction increased significantly (P<0.001). The mean left ventricular, end diastolic diameter decreased significantly (P<0.001). Conclusions Surgical closure of left ventricular aneurysm can be performed during off-pump coronary artery bypass. The operation is associated with a low inhospital mortality and morbidity. A postoperative improvement in the early term cardiac functions and symptoms and quality of life was documented, increasing our expectations of an increased long-term survival.

  2. A serious game for off-pump coronary artery bypass surgery procedure training.

    Science.gov (United States)

    Cowan, Brent; Sabri, Hamed; Kapralos, Bill; Moussa, Fuad; Cristancho, Sayra; Dubrowski, Adam

    2011-01-01

    We have begun development of an interactive, multi-player serious game for the purpose of training cardiac surgeons, fellows, and residents the series of steps comprising the Off-Pump Coronary Artery Bypass grafting (OPCAB) surgical procedure. It is hypothesized that by learning the OPCAB procedure in a "first-person-shooter gaming environment", trainees will have a much better understanding of the procedure than by traditional learning modalities. The serious game will allow for simulation parameters related to levels of fidelity to be easily adjusted so that the effect of fidelity on knowledge transfer can be examined.

  3. Awake off-pump coronary artery bypass surgery in 25 patients

    Institute of Scientific and Technical Information of China (English)

    GUO Huiming(郭惠明); Murali Chakravarthy; Vivek Jawali; K Jayaprakash; NV Shivananda

    2003-01-01

    Objectives To test the fea-sibility of the use of high thoracic epidural anesthesia as a sole anesthetic in patients undergoing off pump coronary artery bypass surgery, avoiding general anesthesia. Methods Between October 2002 to April 2003, twenty five cases underwent beating heart coronary artery revascularization without endotracheal general anesthesia, using high thoracic epidural anesthesia and analgesia. All the patients underwent epidural catheterization on the evening before the surgery. Results The patients in all received 71 grafts (single n = 11, double n = 5, triple n = 6, quadruple n = 3). Six patients underwent repeat coronary artery bypass. Except one was converted to general anesthesia and cardiopulmonary bypass, the other patients underwent off-pump coronary artery bypass graft surgery, 2 patients underwent grafting via left thoracotomy (MIDCAB) and the rest through mid sternotony. There was no mortality. Mean length of stay in the intensive care tnit was 16.2 ( 4.2 hours and hospital was 3.0(1.2 days. Conclusions Our experience confirms the feasibility of performing multiple coronary artery bypassesin conscious patients without endotracheal general an esthesia.

  4. Off-pump coronary artery bypass grafting versus optimal medical therapy alone:effectiveness of incomplete revascularization in high risk patients

    Institute of Scientific and Technical Information of China (English)

    Filippo Prestipino; Cristiano Spadaccio; Antonio Nenna; Fraser WH Sutherland; Gwyn W Beattie; Mario Lusini; Francesco Nappi; Massimo Chello

    2016-01-01

    BackgroundGeriatric patients with multivessel coronary artery disease (CAD) are a challenging group to treat; these cases elicit dis-cussion within heart teams regarding the actual benefit of undertaking major surgery on these patients and often lead to abandon the surgical option. Percutaneous procedures represent an important option, but coronary anatomy may be unfavorable. Off-pump coronary artery bypass (OPCAB) provides good quality graft on left anterior descending (LAD) without exposing the patient to cardiopulmonary bypass, and might be the ideal choice in patients with multiple comorbidities, not eligible to percutaneous or on-pump procedures. The objective of this study was to compare survival during a mid-term follow-up in high-risk patients with no percutaneous alternative, either treated with OPCAB or discharged in medical therapy.MethodsWe retrospectively evaluated from June 2008 to June 2013, 83 high-risk patients with multivessel CAD were included: 42 were treated with incomplete off-pump revascularization using left internal mammary artery (LIMA) on LAD; 41 were discharged in optimal medical therapy (OMT), having refused surgery. Follow-up ended in March 2015, with a telephonic interview. Primary endpoint was survival from all-cause mortality; secondary endpoints were survival from cardiac-related mortality and freedom from non-fatal major adverse cardiac events (MACEs).ResultsDuring follow up, 11 deaths in OPCAB group and 27 deaths in OMT group occurred. Death was due to cardiac factors in 6 and 15 patients, respectively. MACEs were observed in 6 patients in OPCAB group and in 4 patients in OMT group. With regards to survival from all-cause mortality, patients who underwent OPCAB survived more than those dis-charged in OMT (Log Rank < 0.001), and OMT group carries a propensity score-adjusted hazard ratio of 3.862 (P < 0.001). With regards to survival from cardiac-related events, patients who underwent OPCAB survived more than those discharged in

  5. Emergency Off-Pump Coronary Artery Bypass Graft Surgery for Patients on Preoperative Intraaortic Balloon Pump.

    Science.gov (United States)

    Ito, Hisato; Mizumoto, Toru; Tempaku, Hironori; Fujinaga, Kazuya; Sawada, Yasuhiro; Teranishi, Satoshi; Shimpo, Hideto

    2016-09-01

    The aim of this study was to investigate early and long-term outcomes of patients with acute coronary syndrome preoperatively requiring intraaortic balloon pump support who underwent emergency off-pump coronary artery bypass graft surgery. One hundred and fifteen patients on preoperative intraaortic balloon pump receiving emergency off-pump coronary artery bypass graft surgery over an 11-year period were evaluated. The median age was 71 years (range, 33 to 87). Acute myocardial infarction and unstable angina were present in 54 patients (47.0%) and 61 patients (53.0%), respectively. Left main disease and triple-vessel disease without left main involvement were present in 74 patients (64.3%) and 33 patients (28.7%), respectively. There were 3 perioperative deaths. Complete surgical revascularization was accomplished in 82 patients (71.3%), and in situ internal thoracic artery graft was used in 96 (83.5%). Late survival, freedom from major adverse cardiac and cerebrovascular events, and freedom from repeat revascularization rates at 5 years were 83.3%, 73.5%, and 84.2%, respectively. The Cox multivariate prognostic predictors of total mortality were preoperative renal impairment (hazard ratio [HR] 7.90; 95% confidence interval [CI]: 3.06 to 20.4) and low ejection fraction (HR 0.94, 95% CI: 0.88 to 0.99). The multivariate risk predictors of major adverse cardiac and cerebrovascular events were preoperative renal impairment (HR 2.68, 95% CI: 1.00 to 7.19) and peripheral vascular disease (HR 2.81, 95% CI: 1.05 to 7.51), and complete revascularization was protective (HR 0.39, 95% CI: 0.19 to 0.81). The multivariate risk factor of repeat revascularization was previous percutaneous coronary intervention (HR 3.26, 95% CI: 1.14 to 9.33), and complete surgical revascularization was also protective (HR 0.30, 95% CI: 0.11 to 0.85). Off-pump coronary artery bypass graft surgery is a feasible option for patients requiring preoperative intraaortic balloon pump support. Copyright

  6. Anesthetic and Surgical Management of Off-Pump Coronary Artery Bypass Grafting in a Patient with Radiocontrast-Induced Nephropathy

    Directory of Open Access Journals (Sweden)

    Mustafa Levent Acar

    2014-02-01

    Full Text Available AbstractThere is a little experience of anesthetic management of patients with radiocontrast induced nephropathy (RCIN. We report anesthetic management of a 75 years-old, diabetic male patient who underwent off-pump CABG surgery with the diagnosis of RCIN following coronary angiography. The treatment of RCIN is limited. Thus supportive approach should be performed while awaiting the recovery of the impaired renal functions. Protracted period of recovery and the deterioration of the patient’s clinical situation, forced us for immediate revascularization. Off-pump CABG was the preferred technique of surgery. Postoperative period was uneventful and patient was discharged. Although waiting for spontaneous resolving of the nephropathy is mostly recommended, Off-pump CABG with balanced anesthesia may be performed safely on patients with RCIN if the patients’ cardiac complaints become worse.

  7. Novel anaesthetic approach for surgical access and haemodynamic management during off-pump coronary artery bypass through a left thoracotomy

    Directory of Open Access Journals (Sweden)

    Madan Mohan Maddali

    2012-01-01

    Full Text Available For myocardial revascularization on a beating heart through a thoracotomy, a properly deployed endobronchial blocker (EBB provides ideal conditions for surgical access. In addition, adequate volume replacement to achieve optimal cardiac performance is a primary goal of haemodynamic management in patients undergoing off-pump coronary artery bypass grafting. To achieve both these ends, this case report describes the combined use of a left-sided EBB along with a volumetric pulmonary artery catheter in a patient who underwent a successful off-pump coronary artery bypass surgery through an anterolateral thoracotomy.

  8. Pulmonary embolism caused by a carbon dioxide blower during off-pump coronary artery bypass grafting.

    Science.gov (United States)

    Hirata, Naoyuki; Kanaya, Noriaki; Yamazaki, Yutaka; Sonoda, Hajime; Namiki, Akiyoshi

    2010-02-01

    We report a rare case of pulmonary embolism (PE) caused by a carbon dioxide (CO2) blower during off-pump coronary artery bypass grafting (OPCAB). When the anastomosis of the right internal thoracic artery to left anterior descending artery was performed, the operator tore the right ventricle outflow track (RVOT) that was adjacent to the left anterior descending artery. Immediately after the anastomosis and repair of the torn RVOT with CO2 blower, the systolic pulmonary artery pressure (PAP) increased from 28 to 64 mmHg, and end-tidal CO2 decreased from 32 to 12 mmHg. Because transesophageal echocardiograph (TEE) showed numerous gas bubbles in the main pulmonary artery, we diagnosed PE caused by invasion of CO2 gas bubbles via the torn RVOT. Although a CO2 blower is useful to enhance visualization of the anastomosis during OPCAB, it should not be used for the venous system because it may cause CO2 embolism.

  9. Off - Pump Coronary Artery Bypass Graft Surgery: A Safe Method For Complete Revascularization

    Directory of Open Access Journals (Sweden)

    Mirkhani S. H

    2002-07-01

    Full Text Available In recent years off-pump coronary artery bypass surgery (OPCAB has emerged as preferred method for revascularization of coronary arteries in relatively selected group of patients. Considering patients receiving incomplete revascularization need significantly higher postoperative catheterization and re-intervention (PTCA or CABG, we performed this study to identify safety and feasibility of this technique for total revascularization in nearly all patients requiring coronary artery graft surgery."nMaterials and Methods: In this study, 150 consecutive patients underwent OPCAB by one surgeon. Octopus device used for regional wall stabilization. Vascular control achieved by ethibond loops, occluder, and shunts. Situations such as cardiomegaly, poor ventricular function, advanced age, hemodynamic instability, and small coronary arteries were not considered contraindications to OPCAB."nResults: Of 150 OPCAB cases, 146 (97.3 percent were completely off-pump. The mean number of grafts per patient was 4.1 (range, 2 to 6. Total 595 distal grafts anastomosed to LAD (140 diagonals (140, right coronary artery (145, left circumflex (164. Thirty-day mortality and myocardial infarction were 0.6 percent and 3.3 percent respectively OPCAB patient experienced lesser postoperative bleeding had shorter stay at surgical intensive care unit and extubated earlier. Conduits used were left internal mammary artery, radial artery and greater saphenous vein."nConclusion: OPCAB is a safe method for complete revascularization in nearly all patients. The OPCAB patients experience less complications, have shorter hospital stay, absolute contraindication for OPCAB other than severe, diffuse coronary artery disease with poor run-off which is better treated by cardiopulmonary bypass.

  10. Feasibility study of bilateral thoracic paravertebral block for postoperative analgesia in patients after off-pump coronary artery bypass grafting

    Institute of Scientific and Technical Information of China (English)

    孙立新

    2014-01-01

    Objective To investigate the feasibility of bilateral thoracic paravertebral block for postoperative analgesia in patients after off-pump coronary artery bypass grafting(OPCABG).Methods Upon the approval of institutional Ethics Committee and informed consent,forty patients ASAⅡorⅢaged 52-77 yr with BMI(body mass index)<30

  11. Enzimas miocárdicas na cirurgia de revascularização sem circulação extracorpórea Myocardial enzymes in off-pump CABG surgery

    Directory of Open Access Journals (Sweden)

    Paulo Roberto SOLTOSKI

    2000-06-01

    myocardial injury and its effect on outcome vs conventional CABG (on-pump remains unclear. MATERIAL AND METHODS: Retrospective study of 303 patients (122 off-pump, 181 on-pump after isolated CABG from Feb/97-Feb/99. CPK and EKG were obtained pre and post-op, MB fraction and troponin T levels were measured postoperatively. Complications were also recorded. The groups were comparable in terms of age (65 ± 10 vs 65 ± 9 yr, CCS and NYHA class. RESULTS: Mean number of grafts was 3.10 on-pump vs 2.26 off-pump. Perioperative myocardial infarction, morbidity and mortality (7/181 vs 6/122 were also comparable. There were higher postoperative CK levels in the on-pump group compared to the off-pump (548 ± 420 vs 236 ± 365. MB fraction was slightly higher in the on-pump group, but not significantly different (62 ± 197 vs 29 ± 46 nor was troponin T levels (3.5 ± 16 vs 3.5 ± 17 were An inverse correlation between the number of grafts and troponin T release in the off-pump group occurred early during our off-pump experience. There was no correlation between graft location and the incidence of infarcts or troponin T release. CONCLUSION: The higher troponin T release during our initial experience subsequently decreased. This suggests that improvements in operative technique (e.g. better exposure allowing more posterior grafts without surface trauma may be responsible. Current techniques make off-pump CABG a safe alternative for revascularization.

  12. Off-Pump Repair of a Post Myocardial Infarction Ventricular Septal Defect

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    Feridoun Sabzi

    2014-01-01

    Full Text Available Refractory cardiogenic shock meant that traditional patch repairs requiring cardiopulmonary bypass would be poorly tolerated and external sandwich closure of post myocardial ventricular septal defect (VSD appears to be simple and effective after initial myocardial infarction (MI. The three cases presented with a VSD after of acute MI with or without thrombolysed with streptokinase during patient admission. The general condition of the three patients was poor with pulmonary edema, low cardiac output and renal failure. The heart was approached through a median sternotomy. Off-pump coronary artery bypass grafting of the coronary artery lesion was done first using octopus and beating heart surgery method and latero - lateral septal plication was performed using sandwich technique. Low cardiac output managed with intra-aortic balloon pump in these patients accompanied with inotropic drugs. Post-operative transesophageal echocardiography revealed that VSD was closed completely in one patient and in two patients small residual VSD remained. More experience is required to ascertain whether this technique will become an accepted alternative to patch repairs.

  13. Heparin responsiveness during off-pump coronary artery bypass graft surgery: predictors and clinical implications

    Institute of Scientific and Technical Information of China (English)

    Duk-hee CHUN; Seong-wan BAIK; So Yeon KIM; Jae Kwang SHIM; Jong Chan KIM; Young Lan KWAK

    2011-01-01

    Aim: To evaluate the clinical impact of reduced heparin responsiveness (HRreduced) on the incidence of myocardial infarction (MI) following off-pump coronary artery bypass graft surgery (OPCAB),and to identify the predictors of HRreduced.Methods: A total of 199 patients scheduled for elective OPCAB were prospectively enrolled. During anastomosis,150 U/kg of heparin was injected to achieve an activated clotting time (ACT) of ≥300 s,and the heparin sensitivity index (HSI) was calculated. HSIs below 1.0 were considered reduced (HRreduced).The relationships between the HSI and postoperative MI,cardiac enzyme levels and preoperative risk factors of HRreduced were investigated.Results: There was no significant relationship between the HSI and cardiac enzyme levels after OPCAB. The incidence of MI after OPCAB was not higher in HRreduced patients. HRreduced occurred more frequently in patients with low plasma albumin concentrations and high platelet counts.Conclusion: HRreduced was not associated with adverse ischemic outcomes during the perioperative period in OPCAB patients,which seemed to be attributable to a tight prospective protocol for obtaining a target ACT regardless of the presence of HRreduced.

  14. [Off-pump coronary artery bypass grafting using donut and SPY].

    Science.gov (United States)

    Takahashi, M; Ishikawa, T; Higashidani, K; Katoh, H

    2003-07-01

    Off-pump coronary artery bypass grafting (OPCAB) has been rapidly increased, because of its less invasiveness with low complications. However, graft patency rate highly depends on operators' capability due to technical difficulties. In this article, detail operative procedures are introduced to perform OPCAB in 100% for isolated coronary patients. Selecting better stabilizer may be a key of success. Donut Heart Stabilizer can make a still and stable operative field to anastomose less than 1 mm coronary artery. It is very useful to achieve complete revascularization for all stenosed coronary branches. OPCAB with 9 arterial grafts could be done using Donut. SPY Intra-operative Imaging System is also important to get 100% patency rate of the grafts. Using SPY, we can avoid graft trouble during operation in operation room (OR). SPY image is the best key information for operators to decide revision of the failed grafting. Donut 2 Heart Stabilizer has been improved to make more wide and stable operative field. Donut and SPY is the best combination for OPCAB.

  15. Sevoflurane at 1 MAC provides optimal myocardial protection during off-pump CABG.

    Science.gov (United States)

    Wang, Jiang; Zheng, Hong; Chen, Chun-Ling; Lu, Wei; Zhang, Yong-Qiang

    2013-06-01

    We investigated the myocardial protective effect of sevoflurane in patients receiving off-pump coronary artery bypass grafting (OPCABG) and the role of brain natriuretic peptide (BNP). Forty-eight patients receiving elective OPCABG were randomly assigned to a control group, and to 0.75 MAC, 1.0 MAC and 1.5 MAC sevoflurane groups. Blood samples were collected and levels of BNP and cardiac troponin I (cTnI) were measured before anesthesia, and immediately, 24, 48 and 72 h after surgery. Dopamine was necessary to maintain blood pressure in the sevoflurane groups, but not in the control group (p MAC sevoflurane significantly decreased post-surgical cTnI levels (p MAC had no significant effect, and increasing sevoflurane concentrations to 1.5 MAC caused no further decrease in cTnI concentrations. There was no significant difference in BNP level among the groups (p = 0.227) or between any two groups, although values of BNP showed a significant correlation with cTnI values in control subjects immediately after (r = 0.847) and 24 h after (r = 0.661) surgery. Our results demonstrated that 1.0 MAC and 1.5 MAC sevoflurane can exert a significant myocardial protective effect. BNP cannot be used to predict the myocardial protective effect of sevoflurane in OPCABG.

  16. Endoscopic vein harvest in elective off-pump coronary artery bypass grafting

    Institute of Scientific and Technical Information of China (English)

    Nai-kuan CHOU; Meng-lin LEE; Shoei-shen WANG

    2009-01-01

    While traditional open vein harvest was related to postoperative wound complications, endoscopic vein harvest was developed to minimize the morbidity in the greater saphenous vein harvest procedure. In this study, these two procedures were compared for postoperative wound healing and long-term graft patency. We reviewed all consecutive patients undergoing elective off-pump coronary artery bypass grafting from January 2004 to December 2005 and collected data regarding wound complications and coronary events. Wound complications included dehiscence, excessive discharge, edema, altered sensation, cellulitis, hema-toma, pain scale, and superlicial and deep wound infection. Coronary events were defined as diagnosis of myocardial infarction during the first year's follow-up. A total of 392 patients were included in our series, among whom 44 were excluded from the study due to emergent operation, preoperative intra-aortic balloon pump support, or the greater saphenous vein varicose characteristic, 78 belonged to open vein harvest group, and 270 to endoscopic vein harvest group. Wound complications were significantly less in the endoscopic group (5.2%) compared to the open group (19.2%) (P=0.0002). There was no significant difference on preopera-tive risk factors, total operative time, or hospitalization days. During one-year follow-up, both the early and late graft patency rates were similar between the two groups. Endoscopic vein harvest is safe and effective, which carries less risk for wound complica-tions and is associated with better satisfaction and cosmetic result than the traditional greater saphenous vein harvest procedure. The endoscopic vein harvest also demonstrates a great long-term patency.

  17. Adenosine Preconditioning versus Ischemic Preconditioning in Patients undergoing Off-Pump Coronary Artery Bypass (OPCAB

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    SeyedKhalil Forouzannia

    2015-10-01

    Full Text Available Background: During off-pump coronary artery bypass (OPCAB, the heart is subjected to ischemic and reperfusion injury. Preconditioning is a mechanism that permits the heart to tolerate myocardial ischemia. The aim of this study was to compare the effects of Adenosine preconditioning with ischemic preconditioning on the global ejection fraction (EF in patients undergoing OPCAB.Methods: In this single-blind, randomized controlled trial, sixty patients undergoing OPCAB were allocated into three equally-numbered groups through simple randomization: Adenosine group, ischemic group, and control group. The patients in the Adenosine group received an infusion of Adenosine. In the ischemic group, ischemic preconditioning was induced by the temporary occlusion of the left anterior descending coronary artery twice for a 2-minute period, followed by 3-minute reperfusion before bypass grafting of the first coronary vessel. The control group received an intravenous infusion of 0.9% saline. Blood samples at different times were sent for the measurement of creatine kinase isoenzyme MB (CK-MB and cardiac troponin I (cTnI. We also recorded electrocardiographic indices and clinical parameters, including postoperative use of inotropic drugs and preoperative and postoperative EF.Results: History of myocardial infarction, hyperlipidemia, diabetes mellitus, kidney disease, preoperative arrhythmias, and utilization of postoperative inotrope was the same between the three groups. The incidence of postoperative arrhythmias was not significant between the three groups. Also, there were no significant differences in preoperative and postoperative EF and the serum levels of enzymes (cTnI and CK-MB between the groups.Conclusion: Based on the findings of this study, there was no significant difference in the postoperative EF between the groups. Although the incidence of arrhythmias was higher in the ischemic preconditioning group than in the other groups, the difference

  18. Passive graft perfusion in off-pump coronary artery bypass grafting

    Institute of Scientific and Technical Information of China (English)

    LU Feng; JI Bing-yang; LIU Jin-ping; LIU Ming-zheng; WANG Gu-yan; HU Sheng-shou

    2007-01-01

    Background Myocardial protection during off-pump coronary artery bypass grafting (OPCABG) is a multifactorial problem in which maintaining stable systemic hemodynamics is very important. In this study passive graft perfusion (PGP) was applied to investigate the effect during and after OPCABG as evaluated by cardiac troponin I (CTnl) and hemodynamic indexes.Methods Thirty first-time patients underwent OPCABG under one surgeon. They were randomly divided into two groups: The passive graft perfusion group (PGP, n=15) received distal coronary perfusion during the anastomosis and immediate graft perfusion after the distal anastomosis. The control group, no graft perfusion group, (NGP, n=15)received no graft perfusion after the distal anastomosis. The results of the two protocols were evaluated by concentration of CTnl and hemodynamic indexes before induction and after operation.Results There were no statistically significant differences between these two groups in their perioperation parameters.The level of CTnl increased postoperatively, reached its peak at 6 hours (P<0.05) and recovered by the 6 days postoperative. Compared with the control group the concentration of CTnl in the PGP group was significantly lower at 6 and 24 hours (P<0.01). Compared with the NGP group, cardiac index (Cl) in the PGP group was higher at 12 and 24 hours after operation (P<0.05). The period of mechanical ventilation was significantly shorter in the PGP group than in the NGP group (P<0.05).Conclusion PGP can increase the flow to the myocardium and shorten the heart ischemia time, thus maintain stable systemic hemodynamics, supply a satisfactory Cl after surgery and improve surgery outcome.

  19. Off-pump total myocardial revascularization in patients with left ventricular dysfunction.

    Science.gov (United States)

    Milani, Rodrigo; Paulo, Brofman; Moutinho, José Augusto; Laura, Barboza; Maximiliano, Guimarães; Alexandre, Barbosa; Lidia, Zitynski; Dalton, Précoma; Alexandre, Varela; Ravanelli, Marcel Rogers; Maia, Francisco

    2007-07-01

    To assess off-pump myocardial revascularization in patients with significant left ventricular dysfunction. Four hundred and five patients with an ejection fraction less than 35% underwent myocardial revascularization without extracorporeal circulation. The procedure was performed with the aid of a suction stabilizer and the LIMA stitch. The distal anastomoses were performed first. A total of 405 patients were evaluated whose mean age was 63.4 +/- 9.78 years. Two hundred and seventy-nine patients were men (68.8%). With regard to risk factors, 347 patients were hypertensive, 194 were smokers, 202 were dyslipidemic, and 134 had diabetes. Two hundred and sixty patients were classified as NYHA functional class III and IV. Twenty patients suffered from chronic renal disease and were under dialysis. Fifty-one underwent emergency surgery, and 33 had been previously operated on. The mean ejection fraction was 27.2 +/- 3.54%. The mean EuroSCORE was 8.46 +/- 4.41. The mean number of anastomoses performed was 3.03 +/- 1.54 per patient. Forty-nine patients (12%) needed an intra-aortic balloon inserted after induction of anesthesia, whereas 73 (18%) needed inotropic support during the perioperative period. As to complications, 2 patients (0.49%) had renal failure, 2 had mediastinitis (0.49%), 7 (1.7%) needed to be reoperated because of bleeding, 5 patients (1.2%) suffered acute myocardial infarction, and 70 patients (17.3%) experienced atrial fibrillation. Eighteen (4.4%) patients died. Based on the data above, we concluded that myocardial revascularization without extracorporeal circulation in patients with left ventricular dysfunction is a safe and effective technique, and an alternative for high-risk patients. Results obtained were better than those predicted by EuroSCORE.

  20. Graft patency in off-pump and conventional coronary artery bypass grafting for treatment of triple vessel coronary disease

    Institute of Scientific and Technical Information of China (English)

    胡盛寿; 王小启; 宋云虎; 吕锋

    2003-01-01

    Objective To compare graft patency in off-pump and conventional coronary artery bypass grafting by using the transit time flow meter in the treatment of triple vessel coronary artery disease. Methods Between June 2000 and April 2001, 60 patients with triple vessel coronary artery disease underwent coronary artery bypass grafting. They were divided into two groups: off-pump and conventional coronary artery bypass. All completed grafts were tested intraoperatively using Transit Time Flow Measurement (TTFM). Preoperative and postoperative variables of the two groups were also compared. Results There were no significant differences in sex, age, weight, acute or remote myocardial infarction, hypertension, diabetes and type of bypass grafts between the two groups. The number of bypass grafts and the assisted respiratory time of the off-pump coronary artery bypass grafting (OPCAB) group were significantly less than those of the conventional coronary artery bypass grafting (CCABG) group. The flow and pulsatile index (PI) of the left anterior descending artery bypass grafts and the right coronary artery bypass grafts were not significantly different between the OPCAB and CCABG groups. The flow of OM in the CCABG group with the multiple anastomosis site of sequential grafts was higher than that in the OPCAB group. Diffused narrow coronary artery bypass grafts in both groups had less flow.Conclusion No signficant differences in graft patency were observed in patients with triple vessel coronary artery disease who had undergone OPCAB or CCABG.

  1. SPY: an innovative intra-operative imaging system to evaluate graft patency during off-pump coronary artery bypass grafting.

    Science.gov (United States)

    Takahashi, Masao; Ishikawa, Toshihiro; Higashidani, Koichi; Katoh, Hiroki

    2004-09-01

    Off-pump coronary artery bypass grafting (CABG) has been rapidly increased, because of its less invasiveness with low complications. However, graft patency rate highly depends on the operators' capability due to technical difficulties. The SPY system, based on the fluorescence of indocyanine green, is an innovative device that permits validation of graft patency intra-operatively. Real time images of grafts are obtained with no need for catheterization, X-rays or iodine contrast medium. High-quality images could be obtained in all 290 grafts of 72 off-pump CABG cases (mean 4.0 grafts per patient). Four anastomoses (1.4%), including two proximal and two distal, were revised because of defects detected by SPY images. In one case, the SPY system revealed no blood flow in a radial sequential graft, although transit-time flow meter measurements showed a diastolic dominant pattern. SPY images provide critical information to surgeons to detect non-patent grafts, allowing them to be revised while the patient is still on the operating table. Using the SPY system, technical failures could be completely resolved during surgery. The use of the SPY system for intra-operative graft validation during off-pump CABG may become the gold standard for surgical management in the near future.

  2. Pulse-pressure variation predicts fluid responsiveness during heart displacement for off-pump coronary artery bypass surgery.

    Science.gov (United States)

    Lee, Jong-Hwan; Jeon, Yunseok; Bahk, Jae-Hyon; Gil, Nam-Su; Kim, Ki-Bong; Hong, Deok Man; Kim, Hyun Joo

    2011-12-01

    The aim of this study was to evaluate the ability of pulse-pressure variation to predict fluid responsiveness during heart displacement for off-pump coronary artery bypass surgery using receiver operating characteristic analysis. A prospective study. A clinical study in a single cardiac anesthesia institution. Thirty-five patients undergoing elective off-pump coronary artery bypass surgery. Central venous pressure, pulmonary arterial occlusion pressure, pulse-pressure variation, and cardiac index were measured 5 minutes after revascularization of the left anterior descending coronary artery and before heart displacement. Immediately after heart displacement for revascularization of the left circumflex artery, and 10 minutes after fluid loading with hydroxyethyl starch 6% (10 mL/kg) during heart displacement, the measurements were repeated. Patients whose cardiac indices increased by ≥15% from fluid loading were defined as responders. After heart displacement, only pulse-pressure variation showed significant difference between the responders and nonresponders (13.48 ± 6.42 v 7.33 ± 3.81, respectively; p fluid responsiveness (area under the curve = 0.839, p = 0.0001). Pulse-pressure variation >7.69% identified the responders, with a sensitivity of 86% and a specificity of 83%. Pulse-pressure variation successfully predicted fluid responsiveness and would be useful in guiding fluid management during heart displacement for off-pump coronary artery bypass surgery. Copyright © 2011 Elsevier Inc. All rights reserved.

  3. The role of neutrophil gelatinase-associated lipocalin in predicting acute kidney injury in patients undergoing off-pump coronary artery bypass graft: A pilot study

    Directory of Open Access Journals (Sweden)

    Vishal Jain

    2016-01-01

    Full Text Available Objective: Acute kidney injury (AKI is a commonly encountered postoperative complication after cardiac surgery especially in high risk patients. AKI though seen more commonly after conventional on pump coronary artery bypass surgery (CCABG, is not uncommon after off pump coronary bypass surgery (OPCAB. Various biomarkers have shown promise over last one decade as an early marker for predicting AKI postoperatively. NGAL is one such biomarker whose concentration is increased in urine after any nephrotoxic and ischemic insult. The objective of this study was to assess the role of urine NGAL in predicting AKI after OPCAB in patients with increased risk of developing AKI. Design: A prospective cohort study. Setting: A clinical study in a multi specialty hospital. Participants: Eighty patients. Materials and Methods: study was approved by the hospital research ethics committee. 80 patients posted for OPCAB with an increased risk of developing AKI defined as having a Cleveland Clinic Foundation Acute renal failure scoring System score of ≥6 were included in the study. Patients with coronary angiography (CAG within 48 hrs prior to surgery, pre-existing AKI, preoperative renal replacement therapy (RRT and CKD stage 5 were excluded. Urine NGAL level before the start of surgery baseline and at 4 hrs post surgery were done. Renal function tests were assessed on the day of surgery (4 hrs post surgery and on the next three days. Result: Seven patients developed AKI as defined by acute kidney infection network (AKIN and risk injury failure loss end stage (RIFLE criteria for AKI. NGAL value at 4 hrs in patients who developed AKI was significantly higher than in those patients who did not develop AKI (P < 0.05. Conclusion: urine NGAL is an early biomarker of acute kidney injury in patients undergoing OPCAB surgeries. However, large multicentre studies may be needed to confirm it.

  4. Pleural subxyphoid drain confers better pulmonary function and clinical outcomes in chronic obstructive pulmonary disease after off-pump coronary artery bypass grafting: a randomized controlled trial

    National Research Council Canada - National Science Library

    Guizilini, Solange; Viceconte, Marcela; Esperança, Gabriel Tavares da M; Bolzan, Douglas W; Vidotto, Milena; Moreira, Rita Simone L; Câncio, Andréia Azevedo; Gomes, Walter J

    2014-01-01

    Objective: To evaluate the lung function and clinical outcome in severe chronic obstructive pulmonary disease in patients undergoing off-pump coronary artery bypass grafting with left internal thoracic artery...

  5. Renal Dysfunction after Off-Pump Coronary Artery Bypass Surgery- Risk Factors and Preventive Strategies

    Directory of Open Access Journals (Sweden)

    Gaurab Maitra

    2009-01-01

    Full Text Available Postoperative renal dysfunction is a relatively common and one of the serious complications of cardiac surgery. Though off-pump coronary artery bypass surgery technique avoids cardiopulmonary bypass circuit induced adverse effects on renal function, multiple other factors cause postoperative renal dysfunction in these groups of patients. Acute kidney injury is generally defined as an abrupt and sustained decrease in kidney function. There is no consen-sus on the amount of dysfunction that defines acute kidney injury, with more than 30 definitions in use in the literature today. Although serum creatinine is widely used as a marker for changes in glomerular filtration rate, the criteria used to define renal dysfunction and acute renal failure is highly variable. The variety of definitions used in clinical studies may be partly responsible for the large variations in the reported incidence. Indeed, the lack of a uniform definition for acute kidney injury is believed to be a major impediment to research in the field. To establish a uniform definition for acute kidney injury, the Acute Dialysis Quality Initiative formulated the Risk, Injury, Failure, Loss, and End-stage Kidney (RIFLE classification. RIFLE , defines three grades of increasing severity of acute kidney injury -risk (class R, injury (class I and failure (class F - and two outcome classes (loss and end-stage kidney disease. Various perioperative risk factors for postoperative renal dysfunction and failure have been identified. Among the important preoperative factors are advanced age, reduced left ventricular function, emergency surgery, preoperative use of intraaortic balloon pump, elevated preoperative serum glucose and creatinine. Most important intraoperative risk factor is the intraoperative haemodynamic instability and all the causes of postoperative low output syndrome com-prise the postoperative risk factors. The most important preventive strategies are the identification of the

  6. 冠状动脉内膜剥脱并冠状动脉搭桥术36例临床分析%Off-pump coronary artery bypass grafting after off-pump coronary endarterectomy in 36 cases

    Institute of Scientific and Technical Information of China (English)

    张力; 王平凡; 梁志强; 朱汝军; 何发明; 郑向阳; 李峰; 崔聪

    2012-01-01

    Objective To summarize the experience and feasibility of off-pump coronary artery bypass grafting (off-pump CABG) after off-pump coronary endarterectomy (CE) for patients with diffused coronary.Methods From January 2001 to July 2011,with diffused coronary artery disease underwent CE without cardiopulmonary bypass and off-pump CABG.Forty endarterectomies were performed in 36 patients totally which included 23 cases in left anterior descending artery(LAD),1 case in obtuse marginal branch and 12 cases in right coronary artery.There were 23 cases left IMA,2 cases radial,arteries,others were great saphenous veins.Results Thirty-six patients discharged uneventfully,noangina re-occurrence.Conclusion CE and bypass grafting without cardiopulmonary bypass is technically feasible and can be performed safely in patients with difused coronary arery disease with increased completeness of myocardial revascularization.%目的 总结冠状动脉搭桥需同期行冠状动脉内膜剥脱以重建心肌血运的临床经验及可行性.方法 回顾性分析河南省胸科医院心血管外科2001年1月至2011年7月收治的36例冠状动脉慢性闭塞患者的临床资料,在外科治疗中发现闭塞冠状动脉远端内膜弥漫增厚,管腔细,遂先行内膜剥脱术,再行冠状动脉搭桥术,以保证该冠脉的血运重建.36例共完成40支冠状动脉内膜剥脱,其中前降支23例,右冠状动脉12例,钝缘支1例.应用左乳内动脉22例,桡动脉2例,余均为大隐静脉.结果 36例患者均痊愈出院,生命体征稳定,中远期效果满意,无心绞痛发作.结论 对冠状动脉闭塞合并远端弥漫增厚的患者先行内膜剥脱术,再行冠状动脉搭桥术,可明显提高再血管化程度,是治疗弥漫冠状动脉病变的有效方法.

  7. Frequency of Acute Kidney Injury in Patients Treated With Normal Saline after Off-Pump Coronary Artery Bypass Grafting

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    Shima Sheybani

    2017-03-01

    Full Text Available Introduction: Acute kidney injury (AKI is a common postoperative complication of cardiac surgery, which is associated with an increased risk of morbidity and mortality. This study investigated the frequency of postoperative AKI in low risk adult patients undergoing off-pump coronary artery bypass grafting (CABG.Materials & Methods: All consecutive adult patients of American Society of Anesthesiologists (ASA class II and III, who were transferred to the post-operative cardiac surgery ICU after off-pump CABG and were low risk for AKI from October 2013 to September 2014 at Emam Reza Hospital, Mashhad, Iran were enrolled in this prospective cohort study at a teaching hospital. The patients were explored for AKI development, based on risk-injury-failure-loss- end stage kidney disease (RIFLE and acute kidney injury network (AKIN criteria, frequency of metabolic acidosis, hypernatremia, hyperchloremia, and length of stay in ICU.Results: According to the results of the present study, 479 patients with the mean age of 60.8±10.75 yrs were included. AKI occurred in 22 (4.4% and23 (4.8% patients, based on both the RIFLE and AKIN criteria, respectively with the highest rate of AKI, reported on the third and fourth post-operative days. Additionally, hyperchloremia and hypernatremia were observed in 71 (14.8% and 76 (15.9% patients, respectively. Only one case of mortality occurred during the study. Metabolic acidosis was reported in 112 (23.4% patients with a high anion gap in 60 (12.5% cases.Conclusion: The current study demonstrated that hypernatremia and metabolic acidosis but not AKI are frequently seen in patients receiving normal saline following off pump CABG with low risk for AKI.

  8. An in vivo model of in situ implantation using pulmonary valved conduit in large animals under off-pump condition

    Institute of Scientific and Technical Information of China (English)

    WU Hao; XU Zhi-wei; LIU Xian-min; GONG Da; WAN Ju-yi; XU Xiu-fang; ZHOU Zi-fan

    2013-01-01

    Background The application of pulmonary valved conduit to reconstruct the continuity between right ventricles and pulmonary artery is one of the major surgeries.This study aimed to establish an in vivo model of in situ implantation using pulmonary valved conduit in large animals under off-pump condition to validate the long-term effects of artificial pulmonary valved conduit.Methods Domesticate juvenile male sheep and tissue-engineered poorine pulmonary valved conduit were used for the experiment:30 sheep,weighing (15±3) kg (range 13 to 17 kg) were randomly divided into two groups which were all operated under general anesthesia by off-pump surgery (group 1) and left thoracotomy (group 2).Two different off-pump surgical methods were used to perform cannulation in sheep pulmonary artery to replace part of sheep pulmonary artery with pulmonary valved conduit which will work together with sheep pulmonary artery and valves.During the experiments,animal survival,complication rates,operating time and blood loss were recorded to compare the results between groups and to establish a surgical method with minimal invasion,simplicity,safety,and high success rates.Results In group 1,a total of 15 cases of surgeries were performed,in which two sheep died; the operative mortality was 13.3% (2/15).In group 2,a total of 15 cases of surgeries were performed,and the surgical mortality rate was 0 (0/15).The operation time and blood loss in group 2 was significantly better than that in group 1.The postoperative echocardiograms showed that,after the surgeries by these two methods,the blood flows were normal,and the valves can open and close freely.Autopsy after 6 months showed that the inner wall and the valves of pulmonary valved conduit were smooth with no thrombus formation.Conclusion These two off-pump methods are feasible and safe with fewer traumas; but the second method is better and particularly suitable for the establishment of a juvenile animal model.

  9. The Predictive Value of Integrated Pulmonary Index after Off-Pump Coronary Artery Bypass Grafting: A Prospective Observational Study

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    Evgenia V. Fot

    2017-08-01

    Full Text Available BackgroundThe early warning scores may increase the safety of perioperative period. The objective of this study was to assess the diagnostic and predictive role of Integrated Pulmonary Index (IPI after off-pump coronary artery bypass grafting (OPCAB.Materials and MethodsForty adult patients undergoing elective OPCAB were enrolled into a single-center prospective observational study. We assessed respiratory function using IPI that includes oxygen saturation, end-tidal CO2, respiratory rate, and pulse rate. In addition, we evaluated blood gas analyses and hemodynamics, including ECG, invasive arterial pressure, and cardiac index. The measurements were performed after transfer to the intensive care unit, after spontaneous breathing trial and at 2, 6, 12, and 18 h after extubation.Results and DiscussionThe value of IPI registered during respiratory support correlated weakly with cardiac index (rho = 0.4; p = 0.04 and ScvO2 (rho = 0.4, p = 0.02. After extubation, IPI values decreased significantly, achieving a minimum by 18 h. The IPI value ≤9 at 6 h after extubation was a predictor of complicated early postoperative period (AUC = 0.71; p = 0.04 observed in 13 patients.ConclusionIn off-pump coronary surgery, the IPI decreases significantly after tracheal extubation and may predict postoperative complications.

  10. Off-pump anteroapical aneurysm plication for left ventricular post-infarction aneurysm: long-term results

    Institute of Scientific and Technical Information of China (English)

    HUANG Xin-sheng; ZHOU Qi-wen; GU Cheng-xiong; YANG Jun-feng; WEI Hua; LI Jing-xing; YU Yang; FANG Ying; LIU Rui; LI Hai-tao

    2012-01-01

    Background The temporal response to off-pump anteroapical aneurysm plication has not been well defined.We have evaluated the long-term clinical and functional results of this technique and compared the efficacy with the patch modeling repair.Methods From March 2005 to May 2010,163 (115 men and 48 women) consecutive patients were operated on for post-infarction left ventricular aneurysm (LVA),54 patients underwent patch remodeling (group A) and 109 patients underwent off-pump anteroapical aneurysm plication repair (group B).All patients had simultaneous coronary revascularization,other operative procedures included septoplasty in eight and ablation of ventricular tachycardia in six.Follow-up ranged from 1 to 5 years,short-term and mid-term outcomes,including complications,cardiac function,and mortality,were assessed.Results Early mortality was 1.8% for all patients (group A 1 death vs.group B 2 deaths,not significant (NS)).Peri-operative support included intraaortic balloon pumping in 16 (9.8%),(group A 6 patients vs.group B 10 patients,NS)and inotropic drugs in 84 (51.5%),(group A 34 vs.group B 50,NS).During a mean follow-up of (3.7±0.8) years,eight patients died,with four due to cardiac-related causes.No patient required transplantation,and two required use of an implantable cardioverter-defibrillator for ventricular tachycardia.Survival at 1 and 5 years was 95% and 86%,respectively.It did not differ significantly between group A and group B.Functional class improved from 2.90±0.59 to 1.65±0.54 among the mid-term survivors (P <0.001),with no significant difference between the two groups.Pre-operative risk factors for mortality or poor function were ejection fraction (EF) <0.35 (OR=7.9,95% CI 1.6-40.0); congestive heart failure (CHF) (OR=4.4,95% CI 1.0-19.0); end-systolic volume index (ESVI) >80 ml/m2 (OR=3.7,95% C/ 1.0-14.0); and advanced age >70 years (OR=2.4,95% C/ 1.0-12.0).Conclusions The technique of off-pump anteroapical aneurysm

  11. Off-pump anastomosis of the left internal mammary artery to the left anterior descending coronary artery through a left inferior J-hemisternotomy

    DEFF Research Database (Denmark)

    Modrau, Ivy; Nielsen, Per Hostrup; Nielsen, Dorthe Viemose

    2016-01-01

    Since the 1990s, a large body of literature has been published regarding minimally invasive coronary artery bypass grafting. Varying techniques, complexity of the procedures and the necessity of patient selection have led to its inconsistent application. We describe the standardized technique...... of left internal mammary artery grafting to the left anterior descending coronary artery, off-pump through a left inferior J-hemisternotomy (JOPCAB). This approach is straightforward, safe, effective, and replicable in virtually all patients. JOPCAB requires no patient selection or other prerequisite than...... experience in standard off-pump technique. The left internal mammary artery is harvested under direct vision through a left inferior J-hemisternotomy. The left anterior descending coronary artery is exposed with left-sided pericardial stitches. The off-pump anastomosis is performed with the aid of a suction...

  12. SPY Imaging Assessment Correlates With Transesophageal Echocardiogram Assessment of Ventricular Function During Off-Pump Coronary Artery Bypass Grafting.

    Science.gov (United States)

    Anderson, Curtis A; Kypson, Alan P; Hudson, Wes; Ferguson, Bruce; Rodriguez, Evelio

    2008-05-01

    Intraoperative assessment of graft anastomoses is commonly performed after off-pump coronary artery bypass grafting (OPCAB). The SPY imaging system allows intraoperative graft assessment. We document correlation between intraoperative SPY images and wall motion abnormality by transesophageal echocardiogram (TEE) during OPCAB. A 79-year-old female underwent OPCAB. Intraoperative graft patency assessment was performed with the SPY and left ventricular wall motion was assessed by TEE. SPY imaging demonstrated poor flow trough the distal vein graft anastomosis to the posterior descending artery, which correlated with a new posterior wall motion hypokinesis. After graft revision, SPY imaging demonstrated good distal flow and the TEE demonstrated normalization of the left ventricular posterior wall motion. SPY technology allows the surgeon to accurately assess graft patency intraoperatively and allows immediate correction of a technical problem.

  13. Sequential saphenous vein grafting combined with selective arterialization of middle cardiac vein during off-pump coronary artery bypass surgery

    Institute of Scientific and Technical Information of China (English)

    YU Yang; QI Dan-ni; GU Cheng-xiong

    2010-01-01

    @@ Currently coronary artery bypass grafting (CABG) is the most commonly used procedure for revascularization of coronary heart disease. However it may not be suitable for the patients with diffuse coronary artery diseases. Under this circumstance, retrograde perfusion via cardiac venous system, namely retrograde coronary venous bypass graft (CVBG), may be the proper therapeutic selection.1 The idea of myocardial revascularization by means of grafting the coronary venous system is more than a century old. However, few clinical trials and long-term outcome data have been presented. The use of venous arterialization has not been widely used. We report the use of a sequential saphenous vein graft from the aorta to middle cardiac vein in a patient with diffuse lesions in right coronary artery during off-pump coronary artery bypass surgery (OPCAB).

  14. Off-pump sequential bilateral internal mammary artery grafting combined with selective arterialization of the coronary venous system

    Institute of Scientific and Technical Information of China (English)

    YU Yang; YAN Xiao-lei; WEI Hua; YANG Jun-feng; GU Cheng-xiong

    2011-01-01

    Background Off-pump coronary artery bypass surgery (OPCAB) has been widely applied in recent years as a less invasive method of myocardial revascularization. This study evaluated the sequential bilateral internal mammary artery grafting combined with selective arterialization of the coronary venous system during OPCAB.Methods From April 2004 to August 2010, patients with diffuse right coronary lesions were studied retrospectively and divided into two groups. Group 1 included seventeen patients who underwent this surgery while group 2 included twenty-one patients without right coronary artery surgical therapy. All patients presented with symptoms of angina. Blood flow of bridged vessels was measured. The perioperative ventricular parameters including left ventricular ejection fraction and end diastolic diameter were compared. During follow-up, myocardial nuclide imaging and coronary angiography were carried out.Results Off-pump coronary artery bypass was performed with an average of 3.6 grafts per patient. Hospital mortality was zero. At the time of follow-up, the patients in group 1 recovered better than in group 2 (P<0.05). In both groups, the mean New York Heart Association (NYHA) class and ejection fraction increased significantly (P<0.001) and the mean left ventricular end-diastolic diameter decreased significantly (P <0.05). Myocardial blood supply of inferior wall in group 1 was obviously improved by myocardial nuclide imaging. Coronary angiography for eight patients in group 1 verified that there was blood flow to myocardium in the arterialized vein.Conclusions Sequential bilateral internal mammary artery grafting combined with selective arterialization of the coronary venous system can be performed during OPCAB. A postoperative improvement in the cardiac functions and the quality of life was documented, increasing our expectation for extensive application.

  15. On-Pump Beating Coronary Artery Bypass in High Risk Coronary Patients

    Directory of Open Access Journals (Sweden)

    Abbas Afrasiabirad

    2015-01-01

    Full Text Available Background: There are some conflicting results with Conventional Coronary Artery Bypass Grafts (CCABG with arrested heart in coronary high-risk patients. Moreover, performing off-pump CABG in these cases may be associated with serious complications. The objective of this study is to evaluate the efficacy of the on-pump beating CABG (OPBCABG in coronary high-risk patients in comparison with the conventional methods. Methods: In a prospective research study, 3000 off-pump CABG patients were considered during June 2003 to December 2011. Among these, 157 patients with one or more of the following risk factors were included for OPBCABG; severe left main stenosis, early post-acute myocardial infarction with ongoing chest pain, unstable angina, intractable ventricular arrhythmia, post complicated coronary intervention and severe left ventricular dysfunction. These patients were compared with 157 similar patients undergone CCABG with aortic cross clamp before 2003. Results: Preoperative patient characteristics revealed no significant differences between the two groups. The patients’ mean age and number of grafts were 57 years and 3 per patient respectively. Hospital mortality was 3.2% and 9% in OPBCABG and CCABG groups, respectively (P<0.001. Preoperative myocardial infarction, requirement of inotropic agents and intraaortic balloon pump, renal dysfunction and prolonged ventilation time were significantly higher in CCABG group. Conclusion: Our results suggest that OPBCABG is effective in coronary high-risk patients and significantly reduces mortality and the incidence of perioperative MI and other major complications.

  16. Off-pump coronary artery bypass grafting or percutaneous transluminal coronary angioplasty with stenting for proximal left anterior descending coronary artery disease?

    NARCIS (Netherlands)

    Drenth, Derk Jan

    2005-01-01

    This thesis describes and discusses the results of a prospective randomized controlled clinical trial comparing percutaneous coronary angioplasty with stenting (stenting) and off-pump coronary artery bypass grafting with a left internal mammary artery (surgery) in patients with a high-grade stenosis

  17. Effect of on/off pumping strategy on sewer sediment behvaviour elucidated by high frequecny monitoring at the treatment plan inlte

    DEFF Research Database (Denmark)

    Sharma, Anitha Kumari; Alferes, J.; Vezzaro, Luca

    to reduce the shock loads at the WWTP. The results for a selected week show that the on/off pumping strategy creates unnecessary peaks with 50-200% increased flows. This affects the water quality arriving at the WWTP, particularly with respect to the total suspended solids concentrations, which increased...

  18. Off-pump coronary artery bypass grafting or percutaneous transluminal coronary angioplasty with stenting for proximal left anterior descending coronary artery disease?

    NARCIS (Netherlands)

    Drenth, Derk Jan

    2005-01-01

    This thesis describes and discusses the results of a prospective randomized controlled clinical trial comparing percutaneous coronary angioplasty with stenting (stenting) and off-pump coronary artery bypass grafting with a left internal mammary artery (surgery) in patients with a high-grade stenosis

  19. [Complete revascularization for multi-vessel coronary diseases through lower ministernotomy on beating heart off-pump surgery].

    Science.gov (United States)

    Xiao, Z B; Zhang, Y; Guo, J Z; Li, Y Y; Zhang, Y P

    2017-06-01

    Objective: To discuss a novel method of complete revascularization for multi-vessel coronary diseases on beating heart off-pump surgery through lower ministernotomy. Methods: Clinical data of 79 patients underwent ministernotomy off-pump coronary artery bypass from January 2015 to May 2016 at Department of Cardiac Surgery, Heart Center, Beijing Friendship Hospital, Capital Medical University were analyzed retrospectively. There were 62 male and 17 female patients, with an average age of (65±9) years. All the patients were multi-vessel coronary diseases and planned to receive coronary artery bypass grafting. Left internal mammary artery, radial artery and great saphenous veins were harvested and prepared, respectively. The perioperative clinical data was observed and collected. Postoperative ventilator-assisted time, intensive care time, and 24-hour thoracic mediastinal drainage volume were recorded. Postoperative cardiac function was evaluated by echocardiography. The data were compared between pre- and post-operative using paired t test. Results: Cardiopulmonary bypass was used in 2 patients during operation because of unstable hemodynamic status, but the incision was not needed to extend for those 2 patients. The lower ministernotomy was converted to traditional full sternotomy in 2 patients due to limited space for proximal anastomosis. In total, 79 patients had an average of (2.8±0.6) grafts. One proximal anastomosis was performed in 75 patients and 2 anastomoses in 4 patients. Distal target vessels consisted of left descending arteries for 79 patients, posterior descending artery for 60 patients, obtuse marginal branch and intermediate branch for 56 patients and diagonal branches for 25 patients, respectively. Average postoperative ventilation time was (19.0±2.2) hours and ICU stay was (60±20) hours. One patient developed postoperative myocardial infarction and needed temporary intra-aortic balloon pump support. One patient was subjected to incision

  20. Cooling device for bradycardia based on Peltier element for accurate anastomosis of off-pump coronary artery bypass grafting.

    Science.gov (United States)

    Kuniyoshi, Yukio; Koja, Kageharu; Miyagi, Kazufumi; Shimoji, Mituyoshi; Uezu, Tooru; Arakaki, Katuya; Yamashiro, Satoshi; Mabuni, Katuhito; Senaha, Shigenobu

    2002-10-01

    Upon introducing off-pump coronary artery bypass grafting (CABG), the indications for CABG were expanded to include patients who previously had no operative indications. For accurate anastomosis, various devices and methods have been developed. Bradycardia is easily induced by drug administration. However, this method of achieving bradycardia also has adverse effects on cardiac function. We have developed a new device to decrease the heart rate by regional cooling of the sino-atrial node. The new device is incorporated with Peltier's element, which uses an electric charge to create a temperature gradient on both of its surfaces. In terms of the cooling ability of this device, its cooling surface is chilled from 25 degrees C to 0 degrees C within 30 s. During in vivo animal experiments, this device has been shown to decrease the myocardial temperature around the sino-atrial node to 15 degrees C and suppress sino-atrial node activity, resulting in bradycardia to 60 beats/min level. In summary, the simple and easily applicable device for local cooling in combination with the application of diltiazem for effective heart rate reduction may be very helpful for the surgeon and may avoid disadvantages for critically ill patients.

  1. Epicardial radiofrequency ablation for left ventricular aneurysm related ventricular arrhythmias during off-pump coronary artery bypass surgery

    Institute of Scientific and Technical Information of China (English)

    YU Yang; GAO Ming-xin; LI Hai-tao; ZHANG Fan; GU Cheng-xiong

    2012-01-01

    Background Left ventricular aneurysm (LVA) is one of the serious complications after acute myocardial infarction.We attempted to evaluate the preliminary efficacy of LVA repair combined with epicardial radiofrequency ablation for ventricular arrhythmia during off-pump coronary artery bypass grafting (OPCAB).Methods From June 2009 to April 2011,31 patients with LVA had angina symptoms and ventricular arrhythmia.In all patients,circular and cross-shaped radiofrequency epicardial ablations were performed using unipolar ablation pen along the border between the aneurysm wall and normal cardiac tissue and in the central zone of the aneurysms,followed by a linear placation of ventricular aneurysms on beating heart.Results All the patients showed complete recovery.The average number of grafted vessels was 2.7±1.3.Intraoperative examinations revealed that the ventricular arrhythmia was effectively controlled by radiofrequency ablation.All cases had been followed up for one year.Holter monitoring revealed a significant reduction in ventricular arrhythmias (P <0.05).Echocardiography showed significant increase in left ventricular ejection fraction (P <0.05) and decrease in left ventricular end-diastolic diameter (P <0.05).Conclusions For patients with ventricular aneurysm and preoperative malignant arrhythmia,aneurysm repair plus epicardial radiofrequency ablation in OPCAB was found to be an effective and feasible therapeutic technique.However,medium-to long-term therapeutic efficacy of this method remains to be determined by future studies and observations.

  2. Thoracic epidural analgesia for off-pump coronary artery bypass surgery in patients with chronic obstructive pulmonary disease.

    Science.gov (United States)

    Mehta, Yatin; Vats, Mayank; Sharma, Munish; Arora, Reetesh; Trehan, Naresh

    2010-01-01

    The benefits of thoracic epidural analgesia in patients undergoing coronary artery bypass grafting are well documented. However, the literature available on the role of high thoracic epidural analgesia (HTEA) in patients with chronic obstructive pulmonary disease undergoing off-pump coronary artery bypass graft (OPCAB) surgery is scarce. We conducted a randomized clinical trial to establish whether HTEA is beneficial in patients with chronic obstructive pulmonary disease undergoing elective OPCAB surgery. After institutional ethics board approval and informed consent, 62 chronic obstructive pulmonary disease patients undergoing elective OPCAB were randomly grouped into two (n = 31 each). Both groups received general anesthesia (GA), but in the HTEA group patients, TEA was also administered. Standardized surgical and anesthetic techniques were used for both the groups. Pulmonary function tests were performed pre-operatively, 6 h and 24 h post-extubation and on days 2, 3, 4 and 5 along with arterial blood gas analysis (ABG) analysis. Time for extubation (h) and time for oxygen withdrawal (h) were recorded. Pain score was assessed by the 10-cm visual analogue scale. All hemodynamic/oxygenation parameters were noted. Any complications related to the TEA were also recorded. Patients in the HTEA group were extubated earlier (10.8 h vs. 13.5 h, P chronic obstructive pulmonary disease patients undergoing elective OPCAB surgery, HTEA is a good adjunct to GA for early extubation, faster recovery of pulmonary function and better analgesia.

  3. Effect of on/off pumping strategy on sewer sediment behvaviour elucidated by high frequecny monitoring at the treatment plan inlte

    DEFF Research Database (Denmark)

    Sharma, Anitha Kumari; Alferes, J.; Vezzaro, Luca

    study illustrates how data with high temporal resolution and advanced DQC tools can be used to: (i) detect unexpected shock loads during dry weather due to an on/off pumping strategy, (ii) understand the processes in upstream sewer systems under wet weather, and (iii) take the necessary actions......Recent developments in on-line sensor technology supplying high temporal resolution data and advanced data quality control (DQC) tools ease the task of understanding in-sewer processes, allowing for better integrated management of sewer systems and wastewater treatment plants (WWTP). The present...... to reduce the shock loads at the WWTP. The results for a selected week show that the on/off pumping strategy creates unnecessary peaks with 50-200% increased flows. This affects the water quality arriving at the WWTP, particularly with respect to the total suspended solids concentrations, which increased...

  4. Preliminary results of combined carotid endarterectomy and off-pump coronary artery bypass grafting in patients with coexistent carotid and coronary artery diseases

    Institute of Scientific and Technical Information of China (English)

    CHEN Xu-jun; CHEN Xin; XIE Dong-hua; SHI Kai-hu; XU Ming

    2009-01-01

    Background Coexistent carotid and coronary artery diseases are common and patients with them remain at a high risk for perioperative stroke or myocardial infarction after coronary bypass surgery.The aim of this study was to investigate the effect of combined carotid endarterectomy (CEA) and off-pump coronary artery bypass grafting (CABG) in patients with coexistent carotid and coronary artery diseases.Methods Between January 2002 and December 2007, consecutive patients with coexistent carotid and coronary artery diseases underwent one-stage unilateral CEA and off-pump CABG in Heart institute of Nanjing First Hospital Affiliated to Nanjing Medical University. Perioperative complications were assessed and follow-up was carried out. Results A total of 51 cases of isolated off-pump CABG and unilateral CEA, including 34 right and 17 left, were performed. The mean blocked time of carotid artery in CEA was (25.5±7.0) minutes. The mean number of distal grafts per patient was 3.30±0.45. The mean ventilation time, intensive care unit stay, and postoperative hospital stay was (11.3±5.4) hours, (2.1 ±0.9) days, and (12.5±6.1) days respectively. None of the patients had stroke or myocardial infarct. There was one perioperative death due to acute cardiac failure, resulting in an operative mortality of 1.96%. Follow-up was completed for 47 patients (92.16%) with a mean follow-up of (39.5±12.5) months. None of the patients manifested stroke, new angina or newly developed cardiac infarct. No late death occurred.Conclusion Combined CEA and off-pump CABG is a safe and effective procedure in selected patients with coexistent carotid and coronary artery diseases.

  5. Sevoflurane causes less arrhythmias than desflurane after off-pump coronary artery bypass grafting: A pilot study

    Directory of Open Access Journals (Sweden)

    Hemmerling Thomas

    2010-01-01

    Full Text Available Background: Volatile anesthetics provide myocardial protection during cardiac surgery. Sevoflurane and desflurane are both efficient agents that allow immediate extubation after off-pump coronary artery bypass grafting (OPCABG. This study compared the incidence of arrhythmias after OPCABG with the two agents. Materials and Methods: Forty patients undergoing OPCABG with immediate extubation and perioperative high thoracic analgesia were included in this controlled, double-blind study; anesthesia was either provided using 1 MAC of sevoflurane (SEVO-group or desflurane (DES-group. Monitoring of perioperative arrhythmias was provided by continuous monitoring of the EKG up to 72 hours after surgery, and routine EKG monitoring once every day, until time of discharge. Patient data, perioperative arrhythmias, and myocardial protection (troponin I, CK, CK-MB-ratio, and transesophageal echocardiography examinations were compared using t-test, Fisher′s exact test or two-way analysis of variance for repeated measurements; P < 0.05. Results: Patient data and surgery-related data were similar between the two groups; all the patients were successfully extubated immediately after surgery, with similar emergence times. Supraventricular tachycardia occurred only in the DES-group (5 of 20 patients, atrial fibrillation was significantly more frequent in the DES group versus SEVO-group, at five out of 20 versus one out of 20 patients, respectively. Myocardial protection was equally achieved in both groups. Discussion: Ultra-fast track anesthesia using sevoflurane seems more advantageous than desflurane for anesthesia, for OPCABG, as it is associated with significantly less atrial fibrillation or supraventricular arrhythmias after surgery.

  6. Nonlinear Heart Rate Dynamics in Off-pump Coronary Artery Bypass Grafting Patients and The Relevance with Atrial Fibrillation and Ventricular Tachycardia

    Institute of Scientific and Technical Information of China (English)

    Wu Zhongkai; Yao Jianping; Huang Xiaodan; Jari Laurikka; Saila Vikman; Matti R. Tarkka

    2007-01-01

    Objectives To elucidate the clinical relevance of nonlinear HRV with postoperative arrhythmias in patients undergoing off-pump CABG. Methods Twenty-seven elective off-pump CABG patients were recruited in the present study. Atrial fibrillation (AF),ventricular tachycardia (VT), linear and nonlinear HRV were analysed using 24-hour electrocardiogram before and after surgery. Results All time domain (SDNN,pNN50 and rMSSD ), frequency domain (LF and HF)of linear measures of HRV variables and nonlinear measures of HRV variable, the short-term fractal-like correlation α1 decreased significantly after surgery. The postoperative nonlinear HRV variable α1 tended to be lower in patients with postoperative AF ( P = 0.056). Significant depressed α1 was found in patients with postoperative VT(P = 0.022 ). Elder patient's age and longer inotropic treatment time negatively correlated with postoperative α1. Conclusions Off-pump CABG procedures resulted in significant depressed of linear and nonlinear HRV variables. The depressed nonlinear HRV variables α1 related to age, inotropic supports and postoperative AF and VT.

  7. Goal-directed therapy improves the outcome of high-risk cardiac patients undergoing off-pump coronary artery bypass

    Directory of Open Access Journals (Sweden)

    Poonam Malhotra Kapoor

    2017-01-01

    Full Text Available Background: There has been a constant emphasis on developing management strategies to improve the outcome of high-risk cardiac patients undergoing surgical revascularization. The performance of coronary artery bypass surgery on an off-pump coronary artery bypass (OPCAB avoids the risks associated with extra-corporeal circulation. The preliminary results of goal-directed therapy (GDT for hemodynamic management of high-risk cardiac surgical patients are encouraging. The present study was conducted to study the outcome benefits with the combined use of GDT with OPCAB as compared to the conventional hemodynamic management. Material and Method: Patients with the European System for Cardiac Operative Risk Evaluation ≥3 scheduled for OPCAB were randomly divided into two groups; the control and GDT groups. The GDT group included the monitoring and optimization of advanced parameters, including cardiac index (CI, systemic vascular resistance index, oxygen delivery index, stroke volume variation; continuous central venous oxygen saturation (ScVO 2 , global end-diastolic volume, and extravascular lung water (EVLW, using FloTrac™ , PreSep™ , and EV-1000 ® monitoring panels, in addition to the conventional hemodynamic management in the control group. The hemodynamic parameters were continuously monitored for 48 h in Intensive Care Unit (ICU and corrected according to GDT protocol. A total of 163 patients consented for the study. Result: Seventy-five patients were assigned to the GDT group and 88 patients were in the control group. In view of 9 exclusions from the GDT group and 12 exclusions from control group, 66 patients in the GDT group and 76 patients in control group completed the study. Conclusion: The length of stay in hospital (LOS-H (7.42 ± 1.48 vs. 5.61 ± 1.11 days, P < 0.001 and ICU stay (4.2 ± 0.82 vs. 2.53 ± 0.56 days, P < 0.001 were significantly lower in the GDT group as compared to control group. The duration of inotropes (3.24 ± 0

  8. Influencing factors for early acute cerebrovascular accidents in patients with stroke history following off-pump coronary artery bypass grafting.

    Science.gov (United States)

    Wang, Bin; Jia, Ming; Jia, Shijie; Wan, Jiuhe; Zhou, Xiao; Luo, Zhimin; Zhou, Ye; Zhang, Jianqun

    2014-06-01

    To analyse risk factors for early acute cerebrovascular accidents following off-pump coronary artery bypass grafting (OPCAB) in patients with stroke history, and to propose preventive measures to reduce the incidence of these events. A total of 468 patients with a history of stroke underwent OPCAB surgery in Beijing Anzhen Hospital of China from January 2010 to September 2012. They were retrospectively divided into two groups according to the occurrence of early acute cerebrovascular accidents within 48 hours following OPCAB. Multivariate logistic regression analysis was used to find risk or protective factors for early acute cerebrovascular accidents following the OPCAB. Fifty-two patients (11.1%) suffered from early acute cerebrovascular accidents in 468 patients, including 39 cases of cerebral infarction, two cases of cerebral haemorrhage, 11 cases of transient ischaemic attack (TIA). There were significant differences between the two groups in preoperative left ventricular ejection fraction ≤ 35%, severe bilateral carotid artery stenosis, poorly controlled hypertension, intraoperative application of Enclose® II proximal anastomotic device, postoperative acute myocardial infarction, atrial fibrillation, hypotension, ventilation time > 48h, ICU duration >48h and mortality. Multivariate logistic regression analysis showed that preoperative severe bilateral carotid stenosis (OR=6.378, 95%CI: 2.278-20.987) and preoperative left ventricular ejection fraction ≤ 35% (OR=2.737, 95%CI: 1.267-6.389), postoperative acute myocardial infarction (OR=3.644, 95%CI: 1.928-6.876), postoperative atrial fibrillation (OR=3.104, 95%CI:1.135∼8.016) and postoperative hypotension (OR=4.173, 95%CI: 1.836∼9.701) were independent risk factors for early acute cerebrovascular accidents in patients with a history of stroke following OPCAB procedures, while intraoperative application of Enclose® II proximal anastomotic device was protective factor (OR=0.556, 95%CI: 0.337-0.925). This

  9. Thoracic epidural analgesia for off-pump coronary artery bypass surgery in patients with chronic obstructive pulmonary disease

    Directory of Open Access Journals (Sweden)

    Mehta Yatin

    2010-01-01

    Full Text Available The benefits of thoracic epidural analgesia in patients undergoing coronary artery bypass grafting are well documented. However, the literature available on the role of high thoracic epidural analgesia (HTEA in patients with chronic obstructive pulmonary disease undergoing off-pump coronary artery bypass graft (OPCAB surgery is scarce. We conducted a randomized clinical trial to establish whether HTEA is beneficial in patients with chronic obstructive pulmonary disease undergoing elective OPCAB surgery. After institutional ethics board approval and informed consent, 62 chronic obstructive pulmonary disease patients undergoing elective OPCAB were randomly grouped into two (n = 31 each. Both groups received general anesthesia (GA, but in the HTEA group patients, TEA was also administered. Standardized surgical and anesthetic techniques were used for both the groups. Pulmonary function tests were performed pre-operatively, 6 h and 24 h post-extubation and on days 2, 3, 4 and 5 along with arterial blood gas analysis (ABG analysis. Time for extubation (h and time for oxygen withdrawal (h were recorded. Pain score was assessed by the 10-cm visual analogue scale. All hemodynamic/oxygenation parameters were noted. Any complications related to the TEA were also recorded. Patients in the HTEA group were extubated earlier (10.8 h vs. 13.5 h, P < 0.01 and their oxygen withdrawal time was also significantly lower (26.26 h vs. 29.87 h, P < 0.01. The VAS score, both at rest and on coughing, was significantly lower in the HTEA group at all times, post-operatively (P < 0.01. The forced vital capacity improved significantly at 6 h post-operatively in the HTEA group (P = 0.026 and remained significantly higher thereafter. A similar trend was observed in forced expiratory volume in the first second on day 2 in the HTEA group (P = 0.024. We did not observe any significant side-effects/mortality in either group. In chronic obstructive pulmonary disease patients

  10. Association of Atrial Fibrillation and Amino-terminal Pro-brain Natriuretic Peptide Concentrations in Patients After Off-Pump Coronary Artery Bypass Grafting

    Institute of Scientific and Technical Information of China (English)

    Junquan Li; Qinghua Zhang; Weichen Tian; Hongyu Liu

    2008-01-01

    Objectives To investigate the possible role of amino-terminal pro-brain natriuretic peptide (NT-proBNP) in the occurrence of atrial fibrillation (AF) after coronary artery bypass grafting (CABG).Methods This study group included 70 consecutive patients scheduled for elective off-pump CABG.The patients with ejection fraction (EF) less than 0.30,history of AF,use of class Ⅰor Ⅲ antiarrhythmic drug,implanted pacemaker,postoperative myocardial infarction or chest reopening for pericardial tamponade were excluded.Preoperative and postoperative serum NT-proBNP levels were measured by radioimmunoassay technique.Results Postoperative AF occurred in 15 patients (21.4%);these patients had significantly higher median NT-proBNP levels when compared with those without AF after the operation (P<0.01).Using multivariate logistic regression analyses,an increase in NT-proBNP level after CABG was found to be independently associated with AF (OR=3.78,95% IC=1.81~4.89,P<0.01 ).Increased age,diabetes mellitus,preoperative use of β-blocker,proximal right coronary artery involvement,and longer operation time were also associated with AF.Conclusions These results indicated that AF was associated with higher NT-proBNP concentrations after off pump CABG;the increase in NT-proBNP after CABG may play an important role in the occurrence of AF after the operation.The further studies are needed to define the reason that lead to higher NT-proBNP concentrations among the patients who present AF after off pump CABG.

  11. Off-Pump Triple Coronary Artery Bypass Grafting in a Patient with Situs Inversus Totalis: Case Presentation and a Brief Review of the Brazilian and the International Experiences

    Science.gov (United States)

    Karigyo, Carlos Junior Toshiyuki; Batalini, Felipe; Murakami, Alexandre Noboru; Teruya, Rogério Toshio; Gregori Júnior, Francisco

    2016-01-01

    A 76-year-old man with situs inversus totalis underwent a successful off-pump three-vessel coronary artery bypass surgery. The postoperative course was uneventful, and the patient was discharged 8 days later. At 9-month follow-up a coronary computed tomography angiography confirmed the viability of all of the grafts, and one year after the operation the patient remained asymptomatic. It comprises the fifth Brazilian case of a coronary surgery in a patient with situs inversus totalis and the first one of the country of a coronary artery bypass surgery without the use of the cardiopulmonary bypass in this condition. PMID:27556323

  12. Off-pump exchange of short-term percutaneous ventricular assist device (VAD) to long-term implantable VAD in severe coagulopathy and multi-organ failure.

    Science.gov (United States)

    Busch, Jonas; Wojciechowski, Zbiguiew; Torre-Amione, Guillermo; Loebe, Matthias

    2008-05-01

    Ventricular support in patients with end-stage heart failure can be achieved using intracorporeal left ventricular assist device (LVAD) or percutaneous ventricular assist device (pVAD) systems. Multiple efforts have been made to minimize procedure-associated complications. We present a case report of an off-pump insertion of a MicroMed DeBakey VAD after Tandem Heart support using a previous sternotomy incision. A 47-year-old woman with end-stage heart failure after coronary artery bypass graft revascularization was admitted for pharmacologic treatment. She developed multi-organ failure and a severe coagulopathy with thromboembolic complications. Heparin-induced thrombocytopenia (HIT) was suspected. A percutaneous Tandem Heart was placed, the patient's condition stabilized, and finally a MicroMed DeBakey Child VAD was implanted off-pump, re-opening a previous sternotomy incision. To avoid the need for heparinization in the light of HIT and severe coagulopathy, the LVAD implantation was performed under Tandem Heart support without cardiopulmonary bypass. The patient has been anti-coagulated with angiomax ever since. Critically ill patients with end-stage heart disease, multi-organ failure, severe coagulopathy and a previous median sternotomy can be bridged from a Tandem Heart to MicroMed DeBakey VAD without cardiopulmonary bypass using the previous incision, provided there are few adhesions and stable hemodynamic conditions.

  13. Cirurgia coronária com condutos arteriais múltiplos sem circulação extracorpórea Off-pump coronary artery bypass with multiple arterial conduits

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    Daniel Navia

    2005-03-01

    circulação extracorpórea utilizando condutos arteriais para a doença de múltiplos vasos é factível com baixa morbimortalidade em 30 dias.OBJECTIVE: To analyze intra-hospital results in patients undergoing elective off-pump total arterial revascularization and identify morbidity and mortality predictors using this surgical strategy. METHOD: From May 1999 to February 2004, 203 myocardial revascularization procedures with total arterial revascularization without cardiopulmonary bypass (off-pump were carried out in patients with multivessel disease (three vessels 81.7 %, one vessel disease was excluded. We report pre-surgical variables and co-morbidities: average age 63.9 ± 9.13 years, men 182 (89.5%, hypertension 132 (65%, smokers 125 (61%, hypercholesterolemia 152 (74.8%, previous myocardial infarction (> 30 days 73 (35%, moderate to severe ventricular dysfunction 31 (15%, redo five (2.5%. Total arterial revascularization included T-grafts and sequential grafts with left internal mammary (100%, right internal mammary (56.6% and radial (63% arteries. The total number of distal anastomosis was 576 (mean of three grafts/patient, all carried out with external mechanical stabilizers. There were no proximal aortic anastomoses. Conversion to on-pump surgery occurred in three (1.5% patients; 90% of the patients was extubated in the operating room. The multiple logistic regression test was used for statistical analysis. RESULTS: The postoperative incidence of atrial fibrillation was 12.8% (26, oligoanuric renal failure 3% (six, dialysis 0.49% (one, postoperative myocardial infarction 1.47% (three, low cardiac output 4% (eight, Redo for bleeding 1.47% (three, mediastinitis 1.47% (three, stroke 1.47% (three. Intra-hospital mortality was 2.45% (five. The only independent 30 day morbidity predictor was age (p=0.033; OR 1.04; IC 95%: 1-1.08. CONCLUSION: Off-pump myocardial revascularization with arterial conduits for multiple vessel disease is feasible with a low 30-day morbidity

  14. Avaliação da função pulmonar em pacientes submetidos à cirurgia de revascularização do miocárdio com e sem circulação extracorpórea Evaluation of pulmonary function in patients following on and off-pump coronary artery bypass grafting

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    Solange Guizilini

    2005-09-01

    Full Text Available OBJETIVO: Avaliar e comparar a função pulmonar em pacientes submetidos à cirurgia de revascularização do miocárdio (RM com e sem circulação extracorpórea (CEC. MÉTODO: Trinta pacientes (média de idade 56,76±10,20 anos foram alocados em dois grupos, de acordo com a utilização ou não da CEC: grupo A (n=15 sem CEC e grupo B (n =15 com CEC. Todos os pacientes foram submetidos à avaliação da função pulmonar. Registros espirométricos da capacidade vital forçada (CVF e do volume expiratório forçado no primeiro segundo (VEF1 foram obtidos no pré, primeiro, terceiro e quinto dias de pós-operatório (PO e a gasometria arterial em ar ambiente, no pré e primeiro dia de PO. RESULTADOS: Em ambos os grupos, houve queda significativa da CVF e do VEF1 até o quinto dia de PO (pOBJECTIVE: To evaluate and compare the pulmonary function in patients following on- and off-pump coronary artery bypass grafting (CABG. METHOD: Thirty patients (mean age 56.76 ± 10.20 years were allocated to two groups, according to the use or not of cardiopulmonary bypasses: group A (n=15 off-pump and group B (n=15 on-pump, with all patients undergoing pre- and post-operative evaluation of the pulmonary function as well as arterial blood gases analysis. Forced vital capacity (FVC and forced expiratory volume at 1 second (FEV1 were recorded in the preoperative period, and on the first, third and fifth postoperative days. Blood gases were evaluated in the preoperative period and on the first postoperative day. RESULTS: In both groups, significant falls in the FVC and FEV1 were detected up to the fifth postoperative day (p<0.05. When both groups were compared, the decreases in FCV and VEF1 were higher in group B (p<0.05. PaO2 values and the PaO2/FiO2 ratio presented significant drops on the first postoperative day in both groups, however the fall was higher in group B (p<0.05. CONCLUSION: Patients who undergo CABG, regardless of the use of CPB, display a

  15. The effects of dexmedetomidine on attenuation of stress response to endotracheal intubation in patients undergoing elective off-pump coronary artery bypass grafting

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    Sajith Sulaiman

    2012-01-01

    Full Text Available This study was designed to study the efficacy of intravenous dexmedetomidine for attenuation of cardiovascular responses to laryngoscopy and endotracheal intubation in patients with coronary artery disease. Sixty adult patients scheduled for elective off-pump coronary artery bypass surgery were randomly allocated to receive dexmedetomidine (0.5 mcg/kg or normal saline 15 min before intubation. Patients were compared for hemodynamic changes (heart rate, arterial blood pressure and pulmonary artery pressure at baseline, 5 min after drug infusion, before intubation and 1, 3 and 5 min after intubation. The dexmedetomidine group had a better control of hemodynamics during laryngoscopy and endotracheal intubation. Dexmedetomidine at a dose of 0.5 mcg/kg as 10-min infusion was administered prior to induction of general anesthesia attenuates the sympathetic response to laryngoscopy and intubation in patients undergoing myocardial revascularization. The authors suggest its administration even in patients receiving beta blockers.

  16. [Off-pump coronary artery bypass grafting for unstable angina pectoris combined with hypothyroidism and chronic renal failure; report of a case].

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    Hirano, Y; Matsumoto, Y; Endoh, M; Kasashima, F; Abe, Y; Sasaki, H

    2002-08-01

    Coronary artery bypass grafting for patients with ischemic heart disease and hypothyroidism contains many controversies, and chronic renal failure causes perioperative water-electrolyte balance disorders. We experienced a case of unstable angina pectoris combined with hypothyroidism and chronic renal failure successfully treated by off-pump coronary artery bypass grafting (OPCAB). A 68-year-old man with a history of hypothyroidism and chronic renal failure was hospitalized with chest pain. Cardiac catheterisation revealed a 90% stenosis of segment 3, 11 and right ventricular (RV) branch, 75% stenosis of segment 6 and 50% stenosis of segment 5. His thyroid function was normal with orally administered levothyroxine. OPCAB was performed safely with hemodialysis until a day before operation and hemofiltration from a day after operation, and postoperative course was uneventful.

  17. A 7-year, single-center research and long term follow-up of graft patency of robotic total arterial off-pump coronary artery bypass grafting

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    Guo-peng LIU

    2016-06-01

    Full Text Available Objective  The aim of the study was to explore the long-term benefits of coronary artery bypass grafting (CABG. Methods  From January 2007 to November 2014, 240 patients (187 males and 53 females, average age 59 years received robotic off-pump CABG assisted with da Vinci Surgical System (Intuitive Surgical, USA in our center. Totally endoscopic coronary artery bypass (totally robot-assisted TECAB, n=100 or mini-thoracotomy direct coronary artery bypass (free of internal mammary artery, IMA, by robot, MIDCAB, n=140 grafting was performed. Patients were followed-up regularly, and their graft patency was assessed every 6 months by coronary angiography or 64-multi-slide CT angiography. Results  All the procedures were completed successfully without conversion to median sternotomy or cardiopulmonary bypass , there was no operative mortality. 237 unilateral IMA grafts (98.7% and 3 bilateral IMA grafts (1.3% were used. Hybrid revascularization of non-left anterior descending vessels was performed in 24 patients (10%. In the follow-up of 41.1±12.9 months, no death, stroke or myocardial infarction occurred. All grafts were patent before discharge. The IMA graft patency was 97.1% in TECAB and 96.4 % in MIDCAB over 3 years (up to 91 months after surgery. Conclusions  Robotic off-pump CABG using IMA grafts is a safe and effective surgery method in selected patients. The long-term outcome and patency of IMA grafts are excellent. DOI: 10.11855/j.issn.0577-7402.2016.06.15

  18. Outcomes of the RESTOR-MV Trial (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve).

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    Grossi, Eugene A; Patel, Nirav; Woo, Y Joseph; Goldberg, Judith D; Schwartz, Charles F; Subramanian, Valavanur; Feldman, Ted; Bourge, Robert; Baumgartner, Norbert; Genco, Christopher; Goldman, Scott; Zenati, Marco; Wolfe, J Alan; Mishra, Yugal K; Trehan, Naresh; Mittal, Sanjay; Shang, Shulian; Mortier, Todd J; Schweich, Cyril J

    2010-12-07

    we sought to determine whether patients with functional mitral regurgitation (FMR) would benefit from ventricular reshaping by the Coapsys device (Myocor, Inc., Maple Grove, Minnesota). FMR occurs when ventricular remodeling impairs valve function. Coapsys is a ventricular shape change device placed without cardiopulmonary bypass to reduce FMR. It compresses the mitral annulus and reshapes the ventricle. We hypothesized that Coapsys for FMR would improve clinical outcomes compared with standard therapies. RESTOR-MV (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve) was a randomized, prospective, multicenter study of patients with FMR and coronary disease with core laboratory analysis. After enrollment, patients were stratified to the standard indicated surgery: either coronary artery bypass graft alone or coronary artery bypass graft with mitral valve repair. In each stratum, randomization was to either control (indicated surgery) or treatment (coronary artery bypass graft with Coapsys ventricular reshaping). the study was terminated when the sponsor failed to secure ongoing funding; 165 patients were randomized. Control and Coapsys both produced decreases in left ventricular (LV) end-diastolic dimension and MR at 2 years (p stroke, myocardial infarction, and valve reoperation) was significantly greater with Coapsys at 2 years (85% vs. 71%) (hazard ratio: 0.372; 95% confidence interval: 0.185 to 0.749; adjusted log-rank test; p = 0.019). analysis of RESTOR-MV indicates that patients with FMR requiring revascularization treated with ventricular reshaping rather than standard surgery had improved survival and a significant decrease in major adverse outcomes. This trial validates the concept of the ventricular reshaping strategy in this subset of patients with heart failure. (Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve [RESTOR-MV]; NCT00120276). Published by Elsevier Inc. All rights

  19. Early Open-Lung Ventilation Improves Clinical Outcomes in Patients with Left Cardiac Dysfunction Undergoing Off-Pump Coronary Artery Bypass: a Randomized Controlled Trial

    Science.gov (United States)

    Bolzan, Douglas W.; Gomes, Walter José; Rocco, Isadora S.; Viceconte, Marcela; Nasrala, Mara L. S.; Pauletti, Hayanne O.; Moreira, Rita Simone L.; Hossne Jr, Nelson A.; Arena, Ross; Guizilini, Solange

    2016-01-01

    Objective To compare pulmonary function, functional capacity and clinical outcomes amongst three groups of patients with left ventricular dysfunction following off-pump coronary artery bypass, namely: 1) conventional mechanical ventilation (CMV); 2) late open lung strategy (L-OLS); and 3) early open lung strategy (E-OLS). Methods Sixty-one patients were randomized into 3 groups: 1) CMV (n=21); 2) L-OLS (n=20) initiated after intensive care unit arrival; and 3) E-OLS (n=20) initiated after intubation. Spirometry was performed at bedside on preoperative and postoperative days (PODs) 1, 3, and 5. Partial pressure of arterial oxygen (PaO2) and pulmonary shunt fraction were evaluated preoperatively and on POD1. The 6-minute walk test was applied on the day before the operation and on POD5. Results Both the open lung groups demonstrated higher forced vital capacity and forced expiratory volume in 1 second on PODs 1, 3 and 5 when compared to the CMV group (P<0.05). The 6-minute walk test distance was more preserved, shunt fraction was lower, and PaO2 was higher in both open-lung groups (P<0.05). Open-lung groups had shorter intubation time and hospital stay and also fewer respiratory events (P<0.05). Key measures were significantly more favorable in the E-OLS group compared to the L-OLS group. Conclusion Both OLSs (L-OLS and E-OLS) were able to promote higher preservation of pulmonary function, greater recovery of functional capacity and better clinical outcomes following off-pump coronary artery bypass when compared to conventional mechanical ventilation. However, in this group of patients with reduced left ventricular function, initiation of the OLS intra-operatively was found to be more beneficial and optimal when compared to OLS initiation after intensive care unit arrival. PMID:27982344

  20. N-acetylcysteine instead of theophylline in patients with COPD who are candidates for elective off-pump CABG surgery: Is it possible in cardiovascular surgery unit?

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    Seyed Jalil Mirhosseini

    2013-01-01

    Full Text Available Background: Forced expiratory volume in one second (FEV1 is a good predictor of chronic obstructive pulmonary disease (COPD. COPD is characterized by a chronic limitation of airflow. This study was designed to compare the effects and complications of theophylline alone, N-acetylcysteine (NAC alone, and a combination of the two drugs on the rates of FEV1 in patients with COPD who were candidates for off-pump coronary artery bypass graft (CABG surgery. Methods: This clinical trial was performed on 100 patients who had a smoking history of 27 pack years with a range of 20 to 40 pack years but were not heavy smokers and were candidates for elective off-pump CABG surgery in Afshar Cardiovascular Hospital, Yazd, Iran. The patients with a history of asthma and bronchospasm and non-COPD respiratory disorders were excluded. There were three groups, that is, the theophylline group (n=33 that received theophylline 10 mg/kg TDS after consumption of food, NAC group (n=33 who received NAC 10-15 mg/kg BD after consumption of food, and the combined group (n=32 who received theophylline and NAC together. Data were analyzed by analysis of variance (ANOVA, Chi-square, and exact test for quantitative and qualitative variables. Results: One hundred patients with COPD enrolled in this study as possible candidates for CABG surgery. Average age of the patients was 60.36±10.21 years. Of the participants, 83 (83.3% were male and 17 (17% were female. Rate of postoperative FEV1 to basal FEV1 was 0.76±0.32, 0.66±0.22, and 0.69±0.24 in the treatments with theophylline, NAC, and the combination, respectively. Theophylline, NAC, and a combination of these drugs can decrease the rate of postoperative FEV1 compared to basal FEV1 significantly. (P=0.0001 Conclusion: Theophylline alone, NAC alone, and a combination of these drugs improve pulmonary function, and there are no significant differences between these protocols. Stomach discomfort and cardiac complications in

  1. The effects of preemptive pregabalin on attenuation of stress response to endotracheal intubation and opioid- sparing effect in patients undergoing off-pump coronary artery bypass grafting

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    Ayya Syama Sundar

    2012-01-01

    Full Text Available The clinical study was designed to evaluate and compare single preoperative dose of pregabalin to a placebo regarding hemodynamic responses to laryngoscopy and endotracheal intubation, to assess perioperative fentanyl requirement and any side-effects. It was a randomized, double-blind, placebo-controlled, parallel assignment, efficacy study. The study was done at a tertiary university hospital. This study was a comparison between two groups of 30 adult patients scheduled for elective off pump coronary artery bypass surgery. In the control group, the patients were given placebo capsules, and in the pregabalin group, the patients were given pregabalin 150 mg capsule orally 1 h before surgery. The patients were compared for hemodynamic changes before the start of the surgery, after induction, 1, 3, and 5 min after intubation. Additionally, fentanyl requirement during surgery and the first postoperative day was also compared. The present study shows that a single oral dose of 150 mg pregabalin given 1 h before surgery attenuated the pressor response to tracheal intubation in adults, but the drug did not show any effect on perioperative opioid consumption and was devoid of side-effects in the given dose.

  2. Prediction of Changes in Left Ventricular Ejection Fraction after Off-Pump Coronary Artery Bypass Grafting Surgery by Myocardial Perfusion Single-Photon Emission Computed Tomography

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    Maryam Mirzaie

    2015-09-01

    Full Text Available Introduction: Left ventricular ejection fraction (LVEF is considered to be the single most important prognostic factor in patients with previous myocardial infarction. LVEF is not improved in all patients after coronary artery bypass grafting (CABG. This study aimed to assess the possibility of prediction of LVEF changes after CABG using myocardial perfusion gated signle photon emission computed tomography (GSPECT. Materials and Methods: Overall, 48 patients with mean LVEF of 30.2% (±4.7 underwent Echocardiography and GSPECT after injection of Tc-99m-MIBI at rest. Myocardial uptake was evaluated in 17 myocardial segments and was compared with age and gender matched normal data pool. The risks and benefits of CABG were explained to the patients and 16 cases (15 male and 1 female with the mean age of 61.1 years (±10.8 accepted to undergo off-pump CABG. All the patients were followed-up for at least six months and echocardiography and GSPECT were repeated at the end of follow up. Results: The mean LVEF was increased from of 31.1% (±3.5 to 34.5% (±3.6 after surgery (P

  3. Effect of thoracic epidural anesthesia on oxygen delivery and utilization in cardiac surgical patients scheduled to undergo off-pump coronary artery bypass surgery: A prospective study

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    Suryaprakash Sharadaprasad

    2011-01-01

    Full Text Available To evaluate the effect of thoracic epidural anesthesia (TEA on tissue oxygen delivery and utilization in patients undergoing cardiac surgery. This prospective observational study was conducted in a tertiary referral heart hospital. A total of 25 patients undergoing elective off-pump coronary artery bypass surgery were enrolled in this study. All patients received thoracic epidural catheter in the most prominent inter-vertebral space between C7 and T3 on the day before operation. On the day of surgery, an arterial catheter and Swan Ganz catheter (capable of measuring cardiac index was inserted. After administering full dose of local anesthetic in the epidural space, serial hemodynamic and oxygen transport parameters were measured for 30 minute prior to administration of general anesthesia, with which the study was culminated. A significant decrease in oxygen delivery index with insignificant changes in oxygen extraction and consumption indices was observed. We conclude that TEA does not affect tissue oxygenation despite a decrease in arterial pressures and cardiac output.

  4. A comparative clinical study of dexmedetomidine versus placebo to attenuate hemodynamic response to endotracheal intubation in patients undergoing off pump coronary arterial bypass grafting

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    Soniya R Sulhyan

    2014-01-01

    Full Text Available Context: Direct laryngoscopy and endotracheal intubation are the most stressful periods during induction of anesthesia. These events can lead to hypertension, tachycardia, arrhythmias and myocardial ischaemia. Aims: (1 To evaluate the haemodynamic response to laryngoscopy and endotracheal intubation with a single preinduction infusion of dexmedetomidine (DEX 1 μg/kg over a 10 min period, (2 To assess the incidence of side effects, that is, rebound hypertension, bradycardia and hypotension etc., associated with the use of DEX. Settings and Design: This was a prospective, double-blind, parallel group randomized clinical trial of DEX (1 μg/kg before anesthetic induction to study the attenuation of hemodynamic response to endotracheal intubation in 60 adult patients undergoing elective off pump coronary arterial bypass grafting. Materials and Methods: Patients were randomly allocated to receive either DEX (DEX group, n = 30 or 0.9% normal saline (PLA group, n = 30. Hemodynamic variables were recorded at baseline (Abbreviated as TB, after completion of drug infusion (Abbreviated as TC, 3 min after induction and immediately before intubation (T0, at the 1 st (T1, 3 rd (T3 and 5 th (T5 min after intubation. Statistical Analysis Used: The data are presented as mean ± standard deviation. Demographic data were analysed by Student′s t-test between the two groups. Analysis of variance for repeated measures f-test was used to analyze changes over time. A P < 0.05 was considered as significant and P < 0.01 or 0.001 was considered as highly significant. Results: All the hemodynamic variables were comparable in both groups at baseline. Heart rate values were statistically significantly lower in the DEX group at TC and highly statistically significantly lower at T1, T3 and T5 values. Systolic blood pressure values were statistically significantly lower in the DEX group at T0 and highly statistically significantly lower at T1, T3 and T5. Diastolic blood

  5. Revascularização miocárdica por minitoracotomia esquerda: série de casos Left mini-thoracotomy off-pump coronary revascularization

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    Theófilo Gauze

    2007-03-01

    Full Text Available OBJETIVO: A reestenose é uma das complicações freqüentes das angioplastias. Estudos demonstraram superioridade da anastomose de Artéria Torácica Interna Esquerda (ATIE para Coronária Interventricular Anterior (DA. Discute-se a indicação, técnica operatória e resultados da Revascularização do Miocárdio por Minitoracotomia Esquerda (MTE sem extracorpórea. MÉTODO: Foram operados 18 pacientes (três mulheres, idade de 56,6±9,2 anos, com "shunt" intracoronário, para anastomose da ATIE para DA (14 casos ou Diagonal (DI e DA (4 homens. Exposição e estabilização foram obtidas com dispositivo Access (CardioThoracicSystems®. O enxerto foi dissecado esqueletizado e anastomosado com fio único de polipropileno 7-0. RESULTADOS: Não ocorreu óbito, conversão para esternotomia, transfusões ou alterações enzimáticas. As altas hospitalares ocorreram entre 3 e 5 dias e todos os pacientes retomaram suas atividades em até 20 dias. Houve uma reinternação por oclusão do enxerto, tratada com angioplastia, e outra por infecção incisional. Seis pacientes reestudados voluntariamente apresentaram angiografia com enxertos pérvios. CONCLUSÃO: A abordagem mostrou-se segura e sem obstáculos técnicos. Houve tempo de hospitalização curto e baixa morbidade, sem uso de hemoderivados. O instrumental apropriado e, casualmente, a aptidão manual esquerda do cirurgião facilitaram a técnica. Estudos randomizados poderão demonstrar se há benefício econômico e/ou clínico, no longo prazo, desta abordagem como tratamento preferencial.OBJECTIVES: Stent restenosis is a common complication in angioplasty. Studies have shown better outcomes when the left internal thoracic artery (LITA is anastomosed to the left anterior descending artery (LAD. Patient selection, operative technique and results for off-pump left mini-thoracotomy (LME coronary surgery, as a pilot study, are presented. METHODS: Eighteen patients (three women with a mean age of 56

  6. High volume practice proved the safety of off-pump coronary artery bypass surgery in left main coronary artery lesions:a two-year single center experience

    Institute of Scientific and Technical Information of China (English)

    LIU Tong; LU Chun-shan; LU Jia-kai; GAN Hui-li; ZHANG Jian-qun; HUANG Fang-jong; GU Cheng-xiong; KONG Qing-yu; CAO Xiang-rong; BO Ping

    2012-01-01

    Background Left main coronary artery (LMCA) stenosis has been recognized as a risk factor for early death among patients undergoing coronary artery bypass grafting (CABG).This study aimed to assess if LMCA lesions pose an additional risk of early or mid-term mortality and/or a major adverse cardiac and cerebrovascular event (MACCE) after off-pump coronary artery bypass grafting (OPCABG),compared with non-left main coronary artery stenosis (non-mainstem disease).Methods From January 1,2009 to December 31,2010,4869 patients had a primary isolated OPCABG procedure at Beijing Anzhen Hospital.According to the pathology of LMCA lesions,they were retrospectively classified as a non-mainstem disease group (n=3933) or a LMCA group (n=936).Propensity scores were used to match the two groups,patients from the non-mainstem disease group (n=831) were also randomly selected to match patients from the LMCA group (n=831).Freedom from MACCE in the two groups was calculated using the Kaplan-Meier method.Results The difference in the mortality and the rate of MACCE during the first 30 days between the non-mainstem disease group and the LMCA group did not reach statistical significance (P=0.429,P=0.127 respectively).With a mean follow-up of (12.8±7.5) months and a cumulative follow-up of 1769.6 patient-years,the difference in the freedom from MACCEs between the two groups,calculated through Kaplan-Meier method,did not reach statistical significance (P=0.831).Conclusion Analysis of a high volume of OPCABG procedures proved that LMCA lesions do not pose additional early and mid-term risk to OPCABG.Therefore,a LMCA lesion is as safe as non-mainstem disease lesion during the OPCABG procedure.

  7. Respiratory physiotherapy and incidence of pulmonary complications in off-pump coronary artery bypass graft surgery: an observational follow-up study

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    Pértega-Díaz Sonia

    2009-07-01

    Full Text Available Abstract Background Heart surgery is associated with an occurrence of pulmonary complications. The aim of this study was to determine whether pre-surgery respiratory physiotherapy reduces the incidence of post-surgery pulmonary complications. Methods Observational study of 263 patients submitted to off-pump coronary artery bypass grafting (CABG surgery at the A Coruña University Hospital (Spain. 159 (60.5% patients received preoperative physiotherapy. The fact that patients received preoperative physiotherapy or not was related to whether they were admitted to the cardiac surgery unit or to an alternative unit due to a lack of beds. A physiotherapist provided a daily session involving incentive spirometry, deep breathing exercises, coughing and early ambulation. A logistic regression analysis was carried out in order to identify variables associated with pulmonary complications. Results Both groups of patients (those that received physiotherapy and those that did not were similar in age, sex, body mass index, creatinine, ejection fraction, number of affected vessels, O2 basal saturation, prevalence of diabetes, dyslipidemia, exposure to tobacco, age at smoking initiation, number of cigarettes/day and number of years as a smoker. The most frequent postoperative complications were hypoventilation (90.7%, pleural effusion (47.5% and atelectasis (24.7%. In the univariate analysis, prophylactic physiotherapy was associated with a lower incidence of atelectasis (17% compared to 36%, p = 0.01. After taking into account age, sex, ejection fraction and whether the patients received physiotherapy or not, we observed that receiving physiotherapy is the variable with an independent effect on predicting atelectasis. Conclusion Preoperative respiratory physiotherapy is related to a lower incidence of atelectasis.

  8. Thoracic epidural analgesia in obese patients with body mass index of more than 30 kg/m 2 for off pump coronary artery bypass surgery

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    Sharma Munish

    2010-01-01

    Full Text Available Perioperative Thoracic epidural analgesia (TEA is an important part of a multimodal approach to improve analgesia and patient outcome after cardiac and thoracic surgery. This is particularly important for obese patients undergoing off pump coronary artery bypass surgery (OPCAB. We conducted a randomized clinical trial at tertiary care cardiac institute to compare the effect of TEA and conventional opioid based analgesia on perioperative lung functions and pain scores in obese patients undergoing OPCAB. Sixty obese patients with body mass index> 30 kg/m 2 for elective OPCAB were randomized into two groups (n=30 each. Patients in both the groups received general anesthesia but in group 1, TEA was also administered. We performed spirometry as preoperative assessment and at six hours, 24 hours, second, third, fourth and fifth day after extubation, along with arterial blood gases analysis. Visual analogue scale at rest and on coughing was recorded to assess the degree of analgesia. The other parameters observed were: time to endotracheal extubation, oxygen withdrawal time and intensive care unit length of stay. On statistical analysis there was a significant difference in Vital Capacity at six hours, 24 hours, second and third day postextubation. Forced vital capacity and forced expiratory volume in one second followed the same pattern for first four postoperative days and peak expiratory flow rate remained statistically high till second postoperative day. ABG values and PaO 2 /FiO 2 ratio were statistically higher in the study group up to five days. Visual analogue scale at rest and on coughing was significantly lower till fourth and third postoperative day respectively. Tracheal extubation time, oxygen withdrawal time and ICU stay were significantly less in group 1. The use of TEA resulted in better analgesia, early tracheal extubation and shorter ICU stay and should be considered for obese patients undergoing OPCAB.

  9. Intra-aortic balloon pump use does not affect the renal function in patients undergoing off pump coronary artery bypass surgery

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    Muniraju Geetha

    2011-01-01

    Full Text Available Renal dysfunction is known to occur during cardiac surgery. A few factors such as perioperative hypotension, use of potential nephrotoxic therapeutic agents, radio opaque contrast media in the recent past, intra-aortic balloon pump (IABP and cardiopulmonary bypass have been blamed as the contributing factors to the causation of postoperative renal dysfunction in cardiac surgical patients. At times, in patients with renal failure and low cardiac output status, one may face the dilemma if the use of IABP is safe. We undertook this prospective observational study to determine the degree of possible renal injury when IABP is used by measuring serial values of serum creatinine and Cystatin C. Elective patients scheduled for off-pump coronary artery bypass surgery requiring preoperative use of IABP were included in this study. Cystatin C and serum creatinine levels were checked at fixed intervals after institution of IABP. Twenty-two patients were eligible for enrolment to the study. There was no significant change in the values of serum creatinine; from the basal value of 1.10 ± 0.233 to 0.98 ± 0.363 mg /dL (P value >0.05. Cystatin C levels significantly decreased from the basal level of 0.98 ± 0.29 to 0.89 ± 0.23 (P value <0.05. Contrary to the belief, Cystatin C, the early indicator of renal dysfunction decreases suggesting absence of renal injury after the use of IABP. Absence of elevation of cystatin C levels in our study suggests the lack of potential of the IABP to cause renal dysfunction in patients who received elective IABP therapy preoperatively.

  10. High concentrations of N-BNP are related to non-infectious severe SIRS associated with cardiovascular dysfunction occurring after off-pump coronary artery surgery.

    Science.gov (United States)

    Kerbaul, F; Giorgi, R; Oddoze, C; Collart, F; Guidon, C; Lejeune, P J; Villacorta, J; Gouin, F

    2004-11-01

    Procalcitonin (PCT) blood concentrations are known to be an appropriate marker of severe systemic inflammatory response syndrome (SIRS) induced by coronary artery surgery with and without cardiopulmonary bypass. Pro-brain natriuretic peptide (N-BNP) is a newly described cardiac hormone considered to be an effective marker of severity and prognosis of acute coronary syndromes and congestive heart failure. We evaluated the perioperative time courses of PCT and N-BNP and investigated their role as early markers of severe SIRS (SIRS with cardiovascular dysfunction) induced by off-pump coronary artery bypass (OPCAB). Sixty-three patients were prospectively included. The American College of Chest Physicians Classification was used to diagnose SIRS and organ system failure to define severe SIRS. Serum concentrations of PCT and N-BNP were determined before, during and after surgery. Receiver operating characteristic curves and cut-off values were used to assess the ability of these markers to predict postoperative severe SIRS. SIRS occurred in 25 (39%) patients. Nine of them (14%) showed severe SIRS. Significantly higher serum concentrations of N-BNP and PCT were found in patients with severe SIRS with peak concentrations respectively at 8887 pg ml(-1) (range 2940-29372 pg ml(-1)) for N-BNP and 9.50 ng ml(-1) (range 1-65 ng ml(-1)) for PCT. The area under the curve using N-BNP to detect postoperative severe SIRS was 0.799 before surgery (0.408 for PCT; Psurgery (0.762 for PCT; PSIRS after OPCAB.

  11. Assessment of feasibility and efficacy of Class IV laser therapy for postoperative pain relief in off-pump coronary artery bypass surgery patients: A pilot study

    Directory of Open Access Journals (Sweden)

    Anil Karlekar

    2015-01-01

    Full Text Available Background: Laser therapy, for its established analgesic properties with minimal side effects, has been used for the treatment of chronic pain. However, it has not been used for the treatment of acute postoperative pain. This pilot study was designed to assess the feasibility and efficacy of Class IV laser on postoperative pain relief following off-pump coronary artery bypass graft (OPCABG surgery, as a component of multimodal analgesia (MMA technique. Methods: This open observational prospective study comprised of 100 adult patients (84 male, 16 female who underwent OPCABG through sternotomy. For postoperative analgesia, they were subjected to laser therapy subjected to laser therapy in addition to the standard institutional pain management protocol comprising of IV infusion/bolus of tramadol and paracetamol and fentanyl bolus as rescue analgesic. Pain intensity was measured by Verbal Rating Scale (VRS. The laser therapy was scheduled as once a day regime for three consecutive postoperative days (PODs starting on POD 1, 30 min following tracheal extubation. The subsequent laser applications were also scheduled at the same time of the day as on day 1 if VRS was ≥5. 10 W Class IV laser was applied over 150 cm 2 sternal wound area for 150 s. VRS was used to assess pain severity and was recorded for statistical analysis using Friedman Test. Results: The mean (standard deviation [SD] VRS of all the 100 patients just before application of the first dose of laser was 7.31 (0.94 while on MMT; the same fell to 4.0 (1.279 and 3.40 (2.697 at 1 h and 24 h respectively following first dose of laser. The change of VRS over first 24 h among all the 100 patients was statistically significant (P = 0.000. Laser was re-applied in 40 patients whose VRS was ≥5 (mean [SD] - 6.38 [0.868] at 24 th h. After receiving the 2 nd dose of laser the VRS scores fell significantly (P = 0.000 and became 0 at 54 th h. No patients required 3 rd dose of the laser. No patient

  12. Partial median sternotomy as a minimal access for off-pump coronary artery bypass grafting: feasibility of the lower-end sternal splitting approach.

    Science.gov (United States)

    Niinami, H; Takeuchi, Y; Ichikawa, S; Suda, Y

    2001-09-01

    Off-pump coronary artery bypass grafting (OPCAB) can be performed in several ways using a minimally invasive approach (MIDCAB). Using the left anterior small thoracotomy (LAST) approach, only the LAD can be grafted. To expand the indications for MIDCAB from single-vessel disease to double-vessel disease, we have used a partial sternotomy without a transverse cut, namely, the lower-end sternal splitting (LESS) approach. Through this approach, the LAD and RCA can be revascularized by means of a single small incision without the risk of damaging the tissue around the intercostal space during harvesting of ITA when the sternum is transversely divided. The purpose of this study was to demonstrate the feasibility and safety of this technique. Between November 1999 and November 2000, a total of 22 patients underwent MIDCAB through a lower midline skin incision from the fourth intercostal space to the xiphoid process with longitudinal division of the lower half sternum up to the 3rd rib, without either a T- or reversed L-shaped division of the sternum. Of the patients, 14 had LAD disease only, 5 had both LAD and RCA disease, 2 had RCA disease only, and 1 had left main trunk disease. Two of the operations were of redo coronary artery bypass grafting. The mean age was 69.5 +/- 6.1 years (range 58 to 77 years). The mean length of the skin incision was 8.5 +/- 1.4 cm (range 7 to 12 cm). No hospital death or morbidity was observed. All patients had arterial conduits: LIMA in 20 patients, RIMA in 3, RGEA in 4, and RA in 1. The mean number of grafts per patient was 1.3 +/- 0.6 (range 1 to 3). No blood transfusion was required perioperatively. The patency rate was 96%. All patients were in New York Heart Association class I and no wound complications or postoperative pain occurred during follow-up. Our experience demonstrates that the LESS approach for MIDCAB is technically feasible for revascularizing not only the LAD but also the RCA system, with the same small incision using

  13. Pleurotomy with subxyphoid pleural drain affords similar effects to pleural integrity in pulmonary function after off-pump coronary artery bypass graft

    Directory of Open Access Journals (Sweden)

    Guizilini Solange

    2012-01-01

    Full Text Available Abstract Background Exacerbation of pulmonary dysfunction has been reported in patients receiving a pleural drain inserted through the intercostal space in comparison to patients with an intact pleura undergoing coronary artery bypass grafting (CABG. Evidence suggests that shifting the site of pleural drain insertion to the subxyphoid position minimizes chest wall trauma and preserves respiratory function in the early postoperative period. The aim of this study was to compare the pulmonary function parameters, clinical outcomes, and pain score between patients undergoing pleurotomy with pleural drain placed in the subxyphoid position and patients with intact pleural cavity after off-pump CABG (OPCAB using left internal thoracic artery (LITA. Methods Seventy-one patients were allocated into two groups: I (n = 38 open left pleural cavity and pleural drain inserted in the subxyphoid position; II (n = 33 intact pleural cavity. Pulmonary function tests and clinical parameters were recorded preoperatively and on postoperative days (POD 1, 3 and 5. Arterial blood gas analysis and shunt fraction were evaluated preoperatively and in POD1. Pain score was assessed on POD1. To monitor pleural effusion and atelectasis chest radiography was performed routinely 1 day before operation and until POD5. Results In both groups a significant impairment was found in lung function parameters until on POD5. However, no significant difference in forced vital capacity and forced expiratory volume in 1 second were seen between groups. A significant decrease in partial pressure of arterial oxygen and an increase in shunt fraction values were observed on POD1 in both groups, but no statistical difference was found when the groups were compared. Pleural effusion and atelectasis until on POD5 were similar in both groups. There were no statistical differences in pain score, duration of mechanical ventilation and postoperative hospital stay between groups. Conclusion Subxyphoid

  14. COMPARISON OF EPIDURAL ANESTHESIA AND POSTOPERATIVE ANALGESIA WITH ROPIVACAINE AND FENTANYL IN OFF - PUMP CORONARY ARTERY BYPASS GRAFTING: A RANDOMIZED, CONTROLLED STUDY

    Directory of Open Access Journals (Sweden)

    Kaushal

    2014-01-01

    Full Text Available BACKGROUND: Our aim was to assess the efficacy of thoracic epidural anesthesia followed by postoperative epidural infusion with ropivacaine and Fentanyl in off - pump coronary bypass grafting. INTRODUCTION : In cardiosurgical patients, high thoracic epidural anesthesia (EA with local anesthetics and opioids can provide effective analgesia and reduce the number of perioperative complications. However, the use of EA in coronary surgery is controversial, and it is still unclear whether EA influences lung fluid balance , cardiopulmonary function and clinical outcome in OPCAB. Thus, the method requires further evaluation and its potential benefits in coronary patients should be weighed against its risks. MATERIALS AND METHODS : A prospective study was performed in 4 0 patients undergoing coronary artery bypass surgery who received high thoracic epidural analgesia. Group 1 received thoracic epidural 0.2% ropivacaine (bolus 10 ml, 10 min before starting surgery while group 2 pts. received Fentanyl 2 mcg/ml (bolus 10 ml , 10 min before starting surgery, then rate of epidural infusion adjusted between 3 - 8 ml/ hr. of the same concentration according to response. The Regimens aimed at a visual analog scale (VAS score < or = 4/10 . Hemodynamic parameters and blood gases were measured from extubation till 24 h after OPCAB. RESULTS : O utcome measures included the incidence of Visual Analogue Score (VAS < or =4/10, infusion rate adjustments and side - effects. Patients receiving ropivacaine were less likely to experience pain < or =4/10 (P' = 0.002; the infusion rate was lower (P' = 0.024; required less rate adjustments (P' = 0.001; a less need for noradrenaline (P' = 0.001 and antiemetic drugs (P' = 0.001. There were no significant differences between the groups for sedation s cores or the incidence of respiratory depression. CONCLUSION : This study suggests that ropivacaine 0.2% may be superior to fentanyl 2 microg/ml. We found a reduced number of

  15. Effect of preoperatively continued aspirin use on early and mid-term outcomes in off-pump coronary bypass surgery: a propensity score-matched study of 1418 patients.

    Directory of Open Access Journals (Sweden)

    Fucheng Xiao

    Full Text Available To date, effect of preoperatively continued aspirin administration in off-pump coronary artery bypass grafting (CABG is less known. We aimed to assess the effect of preoperatively continued aspirin use on early and mid-term outcomes in patients receiving off-pump CABG.From October 2009 to September 2013 at the Fuwai Hospital, 709 preoperative aspirin users were matched with unique 709 nonaspirin users using propensity score matching to obtain risk-adjusted outcome comparisons between the two groups. Early outcomes were in-hospital death, stroke, intra- and post-operative blood loss, reoperation for bleeding and blood product transfusion. Major adverse cardiac events (death, myocardial infarction or repeat revascularization, angina recurrence and cardiogenic readmission were considered as mid-term endpoints.There were no significant differences among the groups in baseline characteristics after propensity score matching. The median intraoperative blood loss (600 ml versus 450 ml, P = 0.56, median postoperative blood loss (800 ml versus 790 ml, P = 0.60, blood transfusion requirements (25.1% versus 24.4%, P = 0.76 and composite outcome of in-hospital death, stroke and reoperation for bleeding (2.8% versus 1.6%, P = 0.10 were similar in aspirin and nonaspirin use group. At about 4 years follow-up, no significant difference was observed among the aspirin and nonaspirin use group in major adverse cardiac events free survival estimates (95.7% versus 91.5%, P = 0.23 and freedom from cardiogenic readmission (88.5% versus 85.3%, P = 0.77 whereas the angina recurrence free survival rates was 83.7% and 73.9% in the aspirin and nonaspirin use group respectively (P = 0.02, with odd ratio for preoperative aspirin estimated at 0.71 (95% confidence interval, 0.49-1.04, P = 0.08.Preoperatively continued aspirin use was not associated with increased risk of intra- and post-operative blood loss, blood transfusion requirements and composite outcome of in

  16. Sequential Vein Bypass Grafting is Not Associated with an Increase of Either In-hospital or Mid-term Adverse Events in Off-pump Coronary Artery Bypass Grafting

    Institute of Scientific and Technical Information of China (English)

    Fucheng Xiao; Jian Wang; Hengchao Wu; Hansong Sun

    2015-01-01

    Background:The impact of sequential vein bypass grafting on clinical outcomes is less known in off-pump coronary artery bypass grafting (CABG).We aimed to evaluate the effects of sequential vein bypass grafting on clinical outcomes in off-pump CABG.Methods:From October 2009 to September 2013 at the Fuwai Hospital,127 patients with at least one sequential venous graft were matched with 127 patients of individual venous grafts only,using propensity score matching method to obtain risk-adjusted outcome comparison.In-hospital measurement was composite outcome of in-hospital death,myocardial infarction (MI),stroke,requirement for intra-aortic ballon pump (IABP) assistance and prolonged ventilation.Major adverse cardiac events (MACEs:Death,MI or repeat revascularization) and angina recurrence were considered as mid-term endpoints.Results:No significant difference was observed among the groups in baseline characteristics.Intraoperative mean blood flow per vein graft was 40.4 ml in individual venous grafts groups versus 59.5 ml in sequential venous grafts groups (P < 0.001).There were no differences between individual and sequential venous grafts groups with regard to composite outcome of in-hospital mortality,MI,stroke,IABP assistance and prolonged ventilation (11.0% vs.14.2%,P =0.45).Individual in-hospital measurement also did not differ significantly between the two groups.At about four years follow-up,the survival estimates free from MACEs (92.5% vs.97.3%,P =0.36) and survival rates free of angina recurrence (80.9% vs.85.5%,P =0.48) were similar among individual and sequential venous grafts groups with a mean follow-up of 22.5 months.In the Cox regression analysis,sequential vein bypass grafting was not identified as an independent predictor of both MACEs and angina recurrence.Conclusions:Compared to individual vein bypass grafting,sequential vein bypass grafting was not associated with an increase of either in-hospital or mid-term adverse events in

  17. Off-pump coronary artery bypass surgery in left main coronary artery disease: the last frontier? Revascularização miocárdica sem circulação extracorpórea em lesão de tronco da artéria coronária esquerda: a última fronteira?

    OpenAIRE

    Leal,João C.; de Godoy, Moacir F.; Braile, Domingo M.; Enio Buffolo

    2003-01-01

    OBJECTIVE: Our aim is to demonstrate the possibility of applying the alternative tactic of off-pump coronary artery bypass surgery to left main coronary artery disease and to assess the long-term results over a 5-year follow-up period. METHODS: Among 210 subjects submitted to off-pump coronary artery bypass, 119 (56.7%) were male. Their ages ranged from 32 to 81 years with a mean age of 59.7. A left coronary artery branch lesion of at least 70% was demonstrated in 48 (22.8%) of the individual...

  18. Reliance on Pumped Mother's Milk Has an Environmental Impact.

    Science.gov (United States)

    Becker, Genevieve; Ryan-Fogarty, Yvonne

    2016-09-10

    Breastfeeding is an environmentally friendly process; however when feeding relies on pumped mother's milk, the environmental picture changes. Waste plastics and heavy metals raise concerns regarding resource efficiency, waste treatment, and detrimental effects on health. Reliance on pumped milk rather than breastfeeding may also effect obesity and family size, which in turn have further environmental impacts. Information on pump equipment rarely includes environmental information and may focus on marketing the product for maximum profit. In order for parents, health workers, and health policy makers to make informed decisions about the reliance on pumped mother's milk, they need information on the broad and far reaching environmental aspects. There was no published research found that examined the environmental impact of using pumped mother's milk. A project is ongoing to examine this issue.

  19. 非体外循环法冠状动脉搭桥术15例报道%Octopus Off- Pump Coronary Artery Bypass Grafting Experience in 15 Patients

    Institute of Scientific and Technical Information of China (English)

    李小波; 单根法; 张辅贤; 杜奇容; 李国庆; 戚晓敏

    2002-01-01

    目的报告15例用"Octopus方法"行冠状动脉搭桥术(Off-Pump coronary artery bypass,OPCAB).方法正中切口非体外循环下"Octopus方法"的冠状动脉搭桥术.1例搭桥1根,1例搭桥2根,搭桥3根以上13例.移植血管:左乳内动脉12根,大隐静脉33根.移植部位:前降支15根,对角支6根,回旋支9根,右冠脉11根,后降支4根. 结果无手术死亡,无术中中转体外循环,术后心绞痛消失,MRI提示桥血管通畅. 结论OPCAB"Octopus方法"适用于多支血管病变,几乎包括所有靶血管,手术效果好,并发症少.

  20. 体外循环与非体外循环下冠状动脉旁路移植术后肾损害%Incidence and risk factors of acute kidney injury post off-pump and on-pump coronary artery bypass grafting

    Institute of Scientific and Technical Information of China (English)

    谷天祥; 张文峰; 修宗谊; 房勤; 张玉海; 王春

    2008-01-01

    目的 探讨体外循环下冠状动脉旁路移植术(CCAB)与非体外循环下冠状动脉旁路移植术(OPCAB)后1周内肾损害及其变化规律.方法 我们对自1990年1月至2006年8月间849例单纯行冠状动脉旁路移植术的病例进行回顾性分析.采用logistic回归模型分析急性肾损害的风险因素.血清肌酐(Scr)130~199μmol/L或矫正的肌酐清除率30~60 ml·min-1.73 m-2作为急性肾损害(AKI)的诊断标准.结果 518例OPCAB发生AKI 61例,331例CCAB发生AKI 63例.AKI的风险因素包括:左心室射血分数(LVEF)>50%、LVEF50%、术中及术后使用IABP可能足保护因素(OR50% and intraoperative and postoperative IABP were associated with lower incidence of AKI( OR<1).Conclusion AKI is not a rare complication post OPCAB or CCAB surgery,especially in patients with reduced LVEF,increased paise pressure,peripheral vascular disease,diabetes,emergent procedure,triple-vessel disease,higher body mass index,intraoperative and postoperative IABP.

  1. A Comparative Study of on-pump and off-pump Coronary Bypass Surgery for Patients with Triple Vessels Disease%体外与非体外循环下冠状动脉搭桥治疗冠状动脉三支病变的对比研究

    Institute of Scientific and Technical Information of China (English)

    陈鑫; 徐明; 史宏伟; 陈振强; 邱志兵; 杨海基; 穆心伟; 蒋英硕; 秦星; 缪劲; 赵扬; 肖立琼; 高岩; 郭子黄

    2004-01-01

    目的:对比研究体外与非体外循环下冠状动脉搭桥治疗冠状动脉三支病变的临床效果.方法:300例单纯冠状动脉多支搭桥患者分别进入常规体外循环下冠状动脉搭桥组(CCABG组,n=150例)和非体外循环冠状动脉搭桥组(OPCAB组,n=150例).两组患者在心绞痛程度、合并慢性阻塞性肺病(COPD)、心肌梗死史和糖尿病、急诊手术和左主干(LM)病变等方面无显著性差异,但OPCAB组手术前有脑梗死史和肾功能异常患者的比例明显多于CCABG组(P均<0.05).所有患者均采用胸骨正中切口.CCABG组在常规CPB心脏停跳下进行,OPCAB组用单根心包深吊线,引入一纱条,帮助暴露各冠状动脉分支,采用心脏局部固定器,辅以腔内分流栓,完成远端吻合.所有患者术终行桥血流定量测定.结果:OPCAB组无1例需转成CCABG.所有患者均在心脏侧壁和后壁区域搭桥.两组人均冠状动脉远端吻合数(OPCAB组:3.84±1.06,CCABG组:3.75±0.94)和再血管化指数相似;手术后呼吸支持时间、胸腔引流量和输血量OPCAB组明显少于CCABG组(P<0.05,P<0.01);OPCAB组呼吸功能不全和肾功能异常发生率低于CCABG(P均<0.05);两组围手术期心肌梗死、脑卒中、房颤发生率和手术病死率无统计学差异.结论:对比研究结果显示,OPCAB可用于冠状动脉三支血管病变,能达到与常规CCABG相似的完全性再血管化,并能减少出血和输血,减少手术并发症.

  2. Miniesternotomia na cirurgia de revascularização miocárdica sem circulação extracorpórea Ministernotomy in off-pump coronary artery bypass surgery

    Directory of Open Access Journals (Sweden)

    Walter J. Gomes

    2005-12-01

    Full Text Available OBJETIVO: Os pacientes com lesão isolada da artéria coronária descendente anterior (ADA se beneficiam mais do tratamento cirúrgico do que com intervenção percutânea. Entretanto, com a menor invasividade da intervenção percutânea, a maioria dos pacientes tem sido direcionada para este procedimento. Relatamos a utilização da miniesternotomia inferior como abordagem para o tratamento de pacientes com lesão única de ADA, com anastomose do enxerto de artéria torácica interna esquerda (ATIE, sem uso de circulação extracorpórea (CEC. MÉTODO: Foram estudados 14 pacientes operados consecutivamente utilizando esta técnica, na qual o enxerto de ATIE foi anastomosado à ADA. A idade média dos pacientes foi 56,7±10,1 anos. A incisão cutânea tinha entre 7 e 9 cm e a porção inferior do esterno foi aberta longitudinalmente. A anastomose foi facilitada com o uso de estabilizadores Octopus-3® (Medtronic. RESULTADOS: Todos os pacientes tiveram boa evolução pós-operatória, com alta hospitalar entre 2 e 6 dias de PO (mediana 3 dias. Não houve alteração de ECG ou elevação enzimática neste grupo. Um paciente foi reinternado por infecção de ferida operatória. CONCLUSÃO: A miniesternotomia permite a realização segura do procedimento cirúrgico de revascularização miocárdica da ADA, sem CEC, com benefício em longo-termo do uso da ATIE.OBJECTIVE: Patients with isolated lesions in the proximal left anterior descending artery (LAD have been demonstrated to benefit more from surgical treatment than percutaneous coronary intervention (PCI. However, with the less invasiveness of PCI, the majority of the patients have been referred for this latter procedure. We report herein on the inferior ministernotomy approach for the treatment of patients with single LAD lesions, with off-pump anastomosis of the left internal thoracic artery graft. METHOD: Fourteen patients, consecutively operated on using this technique with the LITA graft

  3. 非体外循环下成人复杂型主动脉缩窄的解剖矫治%Off-pump Anatomic Surgical Repair for Complex Coarctation in Adults

    Institute of Scientific and Technical Information of China (English)

    孙宏涛; 于存涛; 常谦; 冯钧; 贺东; 钱向阳; 徐晋

    2011-01-01

    目的 为提高成人复杂型主动脉缩窄的矫治效果,探讨其最佳外科治疗策略.方法 回顾性分析北京阜外心血管病医院2005年1月至2008年12月在非体外循环下一期解剖矫治7例成人复杂型主动脉缩窄患者的临床资料,其中男5例,女2例;年龄16~41岁,平均年龄24.4岁.合并主动脉弓发育不良2例,主动脉弓部动脉瘤1例,胸降主动脉瘤3例(其中合并B型主动脉夹层1例),主动脉缩窄手术后再狭窄1例.全组患者术前均通过彩色超声心动图、CT或磁共振成像确诊.均在全身麻醉常温非体外循环下手术,手术入路为胸骨正中切口1例,左后外侧切口6例;解剖矫治为:主动脉弓补片加宽4例,降主动脉人工血管置换3例(其中1例同期行腹主动脉置换,1例B型主动脉夹层同期植入支架象鼻).结果 全组无手术死亡,无严重手术并发症.随访7例,随访时间6~49个月,平均随访20.1个月,无远期死亡,无主动脉缩窄复发二次手术患者.有1例术后出现声音嘶哑,随访11个月时声音嘶哑未改善.结论 非体外循环下对成人复杂型主动脉缩窄行一期解剖矫治是安全可行的,近、远期效果良好.%Objective To investigate the clinical results of off-pump anatomic surgical repair for complex coarctation in adults. Methods We retrospectively analyzed the clinical data of 7 patients with complex coarctation who underwent one-stage anatomic surgical repair between January 2005 and December 2008 in Fu Wai Hospital.There were 5 males and 2 females with the age ranged from 16 to 41 years, average at 24.4 years. Among all the patients, there were 2 patients of coarctation with hypoplastic aortic arch, 1 of coarctation with aortic arch aneurysm,3 of coarctation with descending thoracic aortic aneurysm, and 1 of coarctation with B type aortic dissection. All patients were diagnosed by color echocardiography, CT or magnetic resonance imaging(MRI). All off-pump operations were

  4. O pré-condicionamento isquêmico influencia a contratilidade ventricular na cirurgia sem extracorpórea Ischemic preconditioning influence ventricular function in off-pump revascularization surgery

    Directory of Open Access Journals (Sweden)

    José Ernesto Succi

    2010-03-01

    órea.BACKGROUND: Ischemic preconditioning is a method that prepares and protects cells to tolerate a long period of ischemia with the least possible injury. OBJECTIVES: Evaluate the influence of ischemic preconditioning over left ventricular function during off-pump myocardial revascularization. METHOD: Forty patients with clinical indication for off-pump myocardial revascularization were randomized in two groups, with or without ischemic preconditioning. Ischemic preconditioning was carried out by performing coronary occlusion for two minutes and releasing blood flow for one minute; two cycles were performed. Left ventricular contractility was evaluated through transesophageal Doppler by measuring blood flow acceleration in the descending aorta - Hemosonic 100. The acceleration measurements were performed at the start of the surgery, after heart positioning and five and ten minutes after coronary occlusion. RESULTS: There was no significant difference in left ventricular contractility between the two groups. At the beginning of the procedure flow acceleration was 9.37 ± 2.9m/s² in the preconditioning group and 12.5 ± 3.1 m/s² in no-preconditioning group (p = 0.23; after positioning of heart, it was 8.47 ± 3.3 and 8.31 ± 3.6 m/s² (p = 0.96; after five minutes - 8.7 ± 4.1 and 7.94 ± 2.9 m/s² (p = 0.80; and after ten minutes - 9.2 ± 4.5 and 7.98 ± 3.4 m/s² (p = 0.71. However, contractility evolution was different throughout time in each group. The preconditioning group maintained left ventricular contractility during the entire procedure, since the beginning (0.52, while the group without ischemic preconditioning presented reduction in left ventricular contractility (p = 0.0034. CONCLUSION: Ischemic preconditioning prevented the decrease in left ventricular contractility during off-pump myocardial revascularization surgery.

  5. Clinical outcomes in randomized trials of off- vs. on-pump coronary artery bypass surgery

    DEFF Research Database (Denmark)

    Møller, Christian H; Penninga, Luit; Wetterslev, Jørn

    2008-01-01

    To assess the clinical outcomes of off- vs. on-pump coronary artery bypass surgery in randomized trials.......To assess the clinical outcomes of off- vs. on-pump coronary artery bypass surgery in randomized trials....

  6. 非停跳冠状动脉搭桥术病生理改变及临床监测%Off-pump coronary artery bypass grafting: pathophysiology and anesthetic monitoring

    Institute of Scientific and Technical Information of China (English)

    赵洪伟; 岳云

    2008-01-01

    Off-pump coronary artery bypass grafting (OPCABG) might reduce perioperative morbidity and improve outcome because of avoidance of cardiopulmonary bypass (CPB). Therefore, OPCABG is performed widely now. However, displacement of the heart and positioning the stabilizer device can result in particular pathophysiologic changes during beating -heart surgery, which make the anesthetic management more difficult. Moreover, these pathophysiologic changes may lead to myocardial ischemia and cardiac dysfunction. Especially, ventricular diastolic function and right ventricular function get more attentions recently. Anesthetist must know well the intraoperative monitoring in which the new type Swan -Ganz catheter and transesophageal echocardiography(TEE) have more important effects on hemodynamic and cardiac performance monitoring. In addition, ventricular pressure - volume loop is an attractive index to assess cardiac function.%非停跳冠状动脉搭桥术(OPCABG)因其避免了体外循环的不良反应,在临床上得到了广泛应用.术中心脏位置的变化和应用心脏固定器,会引起显著的血流动力学波动、心肌缺血等病生理改变,进而导致心室功能障碍.近年的研究表明,心室舒张功能障碍和右心功能不全是引起血流动力学变化的重要因素.临床上多采用肺动脉导管(PAC)和经食道超声心动图(TEE)来监测术中血流动力学和心功能的变化.新型的PAC能够将容量监测和压力监测结合起来,拓展了其监测范围和功能;而TEE在术中辅助诊断和监测的可靠性、有效性得到了广泛认可.心室压力一容量环作为一种非容量依赖性的方法,在监测心功能方面越来越受到重视.

  7. Agreement between cardiac index measured with FloTrac-Vigileo system and pulmonary artery catheter in patients undergoing off-pump coronary artery bypass grafting%非体外循环冠状动脉旁路移植术患者FloTrac-Vigileo系统与肺动脉导管技术监测心指数的一致性

    Institute of Scientific and Technical Information of China (English)

    杜伯祥; 史宏伟; 宋杰

    2014-01-01

    Objective To determine if the cardiac index (Cl) measured with FloTrac-Vigileo system agrees with that measured with pulmonary artery catheter (PAC).Methods Forty-three ASA Ⅱ or Ⅲ patients aged 53-75 yr weighing 46-100 kg undergoing off-pump coronary artery bypass grafting were included in this study.Anesthesia was induced with midazolam,sufentanil,propofol and rocuronium and maintained with propofol,remifentanil and atracurium.One MAC sevoflurane was inhaled at breast bone splitting and closing.Cl was measured with FloTrac-Vigileo system and PAC before,and at 5,15 min of sevoflurane inhalation and recorded.All data were compared by Bland-Altman analysis and with kappa coefficient for agreement and percentage error was calculated.Results Bland-Altman comparison of FloTrac-Vigileo system and PAC:matching data of 258 measurements:Cl (2.8 ± 0.6) L·min-1 ·m-2,bias was 0.23 L·min-1 ·m-2 and limit of agreement was (-0.57,1.02) L·min-1 ·m-2,resulting in κ =0.546 and an overall percentage error of 28.6%.Conclusion Cl values obtained by FloTrac-Vigileo system agrees well with that obtained by thermodilution technique using PAC in patients undergoing off-pump coronary artery bypass grafting.

  8. Reliance on Pumped Mother’s Milk Has an Environmental Impact

    Directory of Open Access Journals (Sweden)

    Genevieve Becker

    2016-09-01

    Full Text Available Breastfeeding is an environmentally friendly process; however when feeding relies on pumped mother’s milk, the environmental picture changes. Waste plastics and heavy metals raise concerns regarding resource efficiency, waste treatment, and detrimental effects on health. Reliance on pumped milk rather than breastfeeding may also effect obesity and family size, which in turn have further environmental impacts. Information on pump equipment rarely includes environmental information and may focus on marketing the product for maximum profit. In order for parents, health workers, and health policy makers to make informed decisions about the reliance on pumped mother’s milk, they need information on the broad and far reaching environmental aspects. There was no published research found that examined the environmental impact of using pumped mother’s milk. A project is ongoing to examine this issue.

  9. Reliance on Pumped Mother’s Milk Has an Environmental Impact

    Science.gov (United States)

    Becker, Genevieve; Ryan-Fogarty, Yvonne

    2016-01-01

    Breastfeeding is an environmentally friendly process; however when feeding relies on pumped mother’s milk, the environmental picture changes. Waste plastics and heavy metals raise concerns regarding resource efficiency, waste treatment, and detrimental effects on health. Reliance on pumped milk rather than breastfeeding may also effect obesity and family size, which in turn have further environmental impacts. Information on pump equipment rarely includes environmental information and may focus on marketing the product for maximum profit. In order for parents, health workers, and health policy makers to make informed decisions about the reliance on pumped mother’s milk, they need information on the broad and far reaching environmental aspects. There was no published research found that examined the environmental impact of using pumped mother’s milk. A project is ongoing to examine this issue. PMID:27626456

  10. On-pump beating heart coronary revascularization: Is it valid for emergency revascularization?

    Science.gov (United States)

    Aydin, Ahmet; Erkut, Bilgehan

    2015-01-01

    On-pump beating heart coronary artery bypass grafting (CABG) may be considered as an alternative to the conventional on-pump surgery in patients presenting with acute coronary syndrome requiring emergency revascularization. This study reports our clinical experience and early outcomes with the on-pump beating heart coronary surgery on patients with acute coronary syndrome. A retrospective study conducted from August 2009 to October 2015, in a regional training and research hospital in Turkey. A total of 1432 patients underwent isolated CABG at our institution. A total of 316 of these patients underwent the on-pump beating heart procedure without cardioplegic arrest by the same surgeon. The time interval from the onset of acute myocardial infarction to CABG was 10 (2.2) hours. The mean number of grafts was 3.0 (0.6). Hospital mortality was 2.9% (9 patients). Twelve patients had low cardiac output syndromes after surgery. Eight of them had renal dysfunction but none of them needed hemodialysis. The mean intensive care unit stay was 3 (2) days and the mean hospital length of stay was 7 (4) days. We think that the on-pump beating heart revascularization technique can be a good choice for emergency CABG of high-risk patients with a multivessel coronary artery disease.

  11. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A B; Smith, G;

    2016-01-01

    BACKGROUND: Many reflux patients remain symptomatic on a standard dose of proton pump inhibitor (PPI). Alginates decrease the number of reflux events by forming a raft on top of the stomach content and thus offer a supplemental mechanism of action to acid suppression. AIM: To assess the efficacy...... of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. METHODS: This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using......: In patients with residual reflux symptoms despite PPI treatment, adding an alginate offers additional decrease in the burden of reflux symptoms (EudraCT/IND Number: 2011-005486-21)....

  12. Bispectral Index as an Indicator of Cerebral Hypoperfusion During Off Pump Coronary Artery Bypass Grafting%脑电双频指数作为脑灌注不足指标在非体外循环下冠状动脉旁路移植术中的应用

    Institute of Scientific and Technical Information of China (English)

    Thomas M. Hemmerling; Jean-Fran(c)ois Olivier; Fadi Basile; Nien Le; Ignatio Prieto; 徐静

    2006-01-01

    非体外循环下冠状动脉旁路移植术(off-pump coronary artery bypass grafting,OPCAB)中常发生心动过缓和低血压.本文报道一例58岁行冠脉左回旋支远端吻合时并发可逆性脑灌注不足的病例.术中行远端吻合时,该患者的脑电双频指数(bispectral index,BIS)从45~50骤降至0.术后在手术室内拔除气管导管即刻的神经系统功能评估正常,无神经系统后遗症.术后恢复顺利,于术后第5天出院.OPCAB术中可能并发脑灌注不足,BIS可用于监测OPCAB术中脑灌注不足的发生.

  13. Serum lactate as a prognostic factor in coronary artery bypass graft operation by on pump method

    OpenAIRE

    Jabbari, Ali; Banihashem, Nadia; Alijanpour, Ebrahim; Vafaey, Hamid Reza; Alereza, Hakimeh; Rabiee, Seyed Mozafar

    2013-01-01

    Background: Lactic acidosis in cardiac surgical patients is a manifestation of systemic inflammation and excess pro-inflammatory cytokine production. This investigation was designed to integrate basic concepts about lactate acidosis with a clinically used of serum lactate in patients under coronary artery bypass surgery (CABG) by on pump method.

  14. FOREWORD: 6th International Conference on Pumps and Fans with Compressors and Wind Turbines (ICPF2013)

    Science.gov (United States)

    Wu, Yulin; Wang, Zhengwei; Yuan, Shouqi; Shi, Weidong; Liu, Shuhong; Luo, Xingqi; Wang, Fujun

    2013-12-01

    The 6th International Conference on Pumps and Fans with Compressors and Wind Turbines (ICPF 2013) was held in Beijing, China, 19-22 September 2013, which was jointly organized by Tsinghua University and Jiangsu University. The co-organizers were Zhejiang University, Zhejiang Sci-Tech University, The State Key Laboratory of Hydroscience and Engineering, The State Key Laboratory of Automotive Safety and Energy and Beijing International Science and Technology Cooperation Base for CO2 Utilization and Reduction. The sponsor of the conference was Concepts NREC. The First International Conference on Pumps and Systems (May 1992), the Second International Conference on Pumps and Fans (October 1995), the Third International Conference on Pumps and Fans (October 1998), and the Fourth International Conference on Pumps and Fans (26-29 August 2002) were all held in Beijing and were organized by the late famous Chinese professor on fluid machinery and engineering, Professor Zuyan Mei of Tsinghua University. The conference was interrupted by the death of Professor Mei in 2003. In order to commemorate Professor Mei, the organizing committee of ICPF decided to continue organizing the conference series. The Fifth Conference on Pumps and Systems (2010 ICPF) took place in Hangzhou, Zhejiang Province, China, 18-21 October 2010, and it was jointly organized by Zhejiang University and Tsinghua University. With the development of renewable energy and new energy in China and in the world, some small types of compressor and some types of pump, as well as wind turbines are developing very fast; therefore the ICPF2013 conference included compressors and wind turbines. The theme of the conference was the application of renewable energy of pumps, compressors, fans and blowers. The content of the conference was the basic study, design and experimental study of compressors, fans, blowers and pumps; the CFD application on pumps and fans, their transient behavior, unsteady flows and multi-phase flow

  15. Analysis of risk factors in male patients with intraoperative ventricular fibrillation undergoing off-pump coronary artery bypass grafting%男性患者非体外循环冠状动脉旁路移植术中心室颤动危险因素分析

    Institute of Scientific and Technical Information of China (English)

    金沐; 李书闻; 卢家凯; 程卫平

    2013-01-01

    目的 分析1516例施行非体外循环冠状动脉旁路移植术(OPCABG)的男性患者术中心室颤动发生的危险因素.方法 回顾性分析麻醉科2007年11月至2009年2月1516例记录齐全的男性患者OPCABG围术期资料.以术中发生心室颤动为因变量,将有统计学意义的单因素进行Logistic回归分析,并用Logistic回归分析模型评价各影响因素的作用大小.结果 全组患者术中发生心室颤动24例(1.6%),无一例死亡.术前左心室射血分数(LVEF)< 40%(P<0.01,OR=17.182)、搭桥数>3支(P <0.05,OR=3.233)和术中发生心房颤动(P<0.01,OR=24.979)为术中发生心室颤动的独立危险因素.结论 患者术前左心室功能差(LVEF <40%)、冠状动脉搭桥支数大于3支和术中发生心房颤动与OPCABG手术中发生心室颤动密切相关.%Objective To analyze the risk factors of intraoperative ventricular fibrillation in male patients undergoing off-pump coronary artery bypass grafting (OPCABG).Methods The perioperative data of 1516 male patients undergoing OPCABG were investigated based on the perioperative OPCABG database from Nov.2007 to Feb.2009.The risk factors were identified by multiple logistic regression.Results 24 patients (1.6%) were suffered from intraoperative ventricular fibrillation and no patient died during OPCABG.Multivariate analysis demonstrated that preoperative ejection fraction (LVEF) less than 40% (P < 0.01,OR =17.182),more than 3 grafts (P < 0.05,OR =3.233) and intraoperative atrial fibrillation (P < 0.01,OR =24.979) were the independent risk factors of intraoperative ventricular fibrillation in male patients undergoing off-pump coronary artery bypass grafting.Conclusion This study shows LVEF less than 40%,more than 3 grafts and intraoperative atrial fibrillation are predominant factors of intraoperative ventricular fibrillation during OPCABG.

  16. Off-pump coronary artery bypass grafting in patients with poor left ventricular function%非体外循环冠状动脉旁路移植术在左心室功能低下患者中的应用

    Institute of Scientific and Technical Information of China (English)

    王军惠; 来永强; 李进华; 戴江; 宋邦荣; 张晗; 柳克晔

    2012-01-01

    Objective;To analysis the surgical results of patients with coronary heart disease and poor left ventricular function using Off-pump coronary artery bypass grafting (OPCAB). Methods; From 2006, 37 patients with poor left ventricular function underwent OPCAB, and hemodynatnic parameters were analyzed retrospectively. Results;Two patients died after operation, and the mortality was 5%. One patient died of pulmonary infection, and the other died of low output syndrome. Intra-aortic balloon pump was used in 21 cases. IABP was implanted in 7 cases pre-operatively, and it was inserted in 14 cases intra-or post-operatively. 37 patients Ejection fraction of left ventricle improved significantly. Left ventricular end-diastolic diameter and left ventricular end-systolic diameter decreased dramatically after surgery. Conclusion: Off-pump coronary artery bypass grafting is a useful technique for patients with poor left ventricular function. Earlier IABP implantation and inotropic agents are useful to decrease the mortality and ICU stay.%目的:分析左心室功能低下(EF<40%)冠心病患者,接受非体外循环冠状动脉旁路移植手术(OPCAB)的疗效,改进左心室功能低下冠心病患者的治疗策略.方法:回顾性分析2006年以来我院手术组对37例左心室功能低下的冠心病患者,行OPCAB后手术前后疗效的对比.结果:2例患者死亡,1例死于术后肺部感染,1例死于术后低心排出量综合征(低心排),病死率5%.21例患者使用主动脉内球囊反搏器(IABP),其中7例在术前放置,14例在术中或术后放置.35例患者术后左心室射血分数(EF值)较术前有明显改善(P<0.05);左心室舒张末期内径、左心室收缩末径均较术前下降(P<0.05).结论:对于左心室功能低下的冠心病患者,OPCAB是一种有效的治疗方法.及时使用主动脉球囊反搏,以及合理应用正性肌力药物对于降低患者病死率,减少患者住院时间具有重要意义.

  17. Padronização da dose de heparina sódica utilizada na cirurgia de revascularização do miocárdio sem circulação extracorpórea Standardization of the sodium heparin dose used in off-pump myocardial revascularization surgery

    Directory of Open Access Journals (Sweden)

    José Glauco Lobo Filho

    2005-09-01

    Full Text Available OBJETIVO: Propor uma metodologia de anticoagulação com heparina sódica monitorizada pelo Tempo de Coagulação Ativada (TCA nos pacientes submetidos à cirurgia de revascularização miocárdica (RM sem circulação extracorpórea (CEC, que promova uma anticoagulação segura (TCA >200 segundos, utilizando uma dose inicial de 1mg heparina sódica/kg de peso. MÉTODO: Quarenta pacientes (30 homens e 10 mulheres, entre 41 e 85 anos, foram submetidos à cirurgia de RM sem CEC, utilizando uma dose inicial de 1mg heparina sódica/kg de peso. Dez minutos após a administração da droga, quando TCA > 200 segundos, iniciava-se a confecção das anastomoses coronarianas. Caso contrário, administrava-se 0,5mg/kg de heparina suplementar. Durante a cirurgia, a cada 30 minutos, novos valores de TCA foram obtidos. Concluídas as anastomoses coronarianas, a heparina foi revertida na proporção de 1:1 utilizando cloridrato de protamina. RESULTADOS: O valor médio de TCA dez minutos pós-heparinização foi de 372,2(+/-104,31 segundos, sem variação estatisticamente significante entre os sexos ou grupos etários (p>0,05. Os valores de TCA, 30 e 60 minutos pós-heparinização, mantiveram-se acima de 200 segundos. Aos 30 minutos, verificou-se diferença estatisticamente significante dos valores do TCA entre os sexos e diferentes idades (pOBJECTIVE: To evaluate a methodology of anticoagulation during off pump coronary artery bypass surgery (CABS that promotes safe anticoagulation during the procedure (Activated Coagulation Time >200 seconds, using an initial dose of 1 mg of sodium heparin/kg weight. METHOD: 40 patients (30 men and 10 women, ages ranging from 41 to 85 years, were submitted to off pump CABS, using an initial sodium heparin dose of 1mg/kg of weight. Ten minutes after that drug was administered, if the ACT was > 200 seconds, we initiated the revascularization procedure. If not, we administered an additional of 0.5mg/kg heparin. During the

  18. 依托咪酯和咪唑安定对不停跳冠状动脉旁路搭桥手术气管插管期间心率和血压影响的比较%Comparison of etomidate and midazolam on heart rate and blood pressure during tracheal intubation in off-pump coronary artery bypass graft

    Institute of Scientific and Technical Information of China (English)

    余奇劲; 杨洁; 陈娟; 尹述洲

    2011-01-01

    Objective To compare the effect of etomidate and midazolam on heart rate and blood pressure during tracheal intubation in off-pump coronary artery bypass graft. Methods Sixty patients scheduled for coronary artery bypass graft surgery without cardiopulmonary bypass shunt were randomly and double-blindly divided into etomidate group ( Group E, n = 30) and midazolam group ( Croup M, n = 30 ) based on the anesthetic used for induction. Electrocardiogram, systolic blood pressure (SBP) , diastolic blood pressure ( DBP) , heart rate ( HR) and pulse oximetry saturation ( SpO-2 ) were measured and recorded continuously, as well as the value of rate-pressure product ( RPP). The time used for tracheal intubation was also recorded. Results In Group M,compared with pre-tracheal intubation,the SBP and DBP of all patients decreased remarkably at the beginning of tracheal intubation ( P < 0.05 ). At 1 minute post-trachealintubation,the SBP,DBP and HR increased remarkably (P <0.01) ; meanwhile, the values of RPP were increased significantly than those at the beginning of tracheal intubation and pre-tracheal intubation (P<0.01). Compared with the values in Croup E,at the beginning of tracheal intubation,the values of SBP and DBP in Group M were significantly decreased ( P < 0.05 and P < 0.01,respectively) , while the values of SBP,DBP and RPP at 1 minute after tracheal intubation were significantly increased ( P < 0. 05 and P <0. 01,respectively). Conclusions Compared with midazolam, etomidate used in anesthetic induction for coronary artery bypass graft surgery without cardiopulmonary bypass shunt may more effectively alleviate the cardiovascular responses to tracheal intubation.

  19. Revascularização do miocárdio sem circulação extracorpórea com enxertos arteriais: análise de 300 casos Off-pump coronary artery bypass grafting with arterial grafts: analysis of 300 cases

    Directory of Open Access Journals (Sweden)

    Rodrigo Milani

    2005-09-01

    arteriais nas operações para revascularização do miocárdio sem circulação extracorpórea não acarretou aumento da morbi-mortalidade imediata nesta série. Os resultados obtidos estão dentro do previsto através do EuroSCORE. O uso de enxertos arteriais em diabéticos deve ser realizado de maneira bastante criteriosa.OBJECTIVE: The present study reviews our immediate experience of off-pump coronary artery bypass grafting using arterial grafts alone. METHOD: Between June 2000 and December 2004, 300 patients were submitted to off-pump myocardial revascularization using only arterial grafts. The left internal mammary artery was the first-choice graft, followed by radial artery and the right mammary artery. RESULTS: The ages of the patients ranged from 33 to 77 years, with 234 male and 66 female. In respect to risk factors for coronary disease, 77% had hypertension, 66% had history of smoking, 53% had high levels of cholesterol and 21% had diabetes. Eighty-four patients (28% had a history of myocardial infarction and 77 (25.6% were using endovenous nitroglycerin in the preoperative period. The ejection fraction was less than 30% in 77 (25.6% patients. A total of 189 patients had multi-vessel disease. The EuroSCORE ranged from 0 to 12 points with an expected mortality rate of 3.7%. The total numbers of distal anastomoses were 838, with a mean of 2.79±0.97 anastomoses per patient. There were six deaths in this series, one caused by renal failure, one caused by metabolic disorders, two caused by mediastinitis, one caused by pneumonia and one caused by bleeding. Diabetes was the only factor associated with mortality. CONCLUSION: The use of arterial grafts in off-pump myocardial revascularization did not increase the immediate mobidity and mortality in this series. The results were similar to the results predicted by EuroSCORE. The use of arterial grafts alone in diabetics patients must be carefully evaluated.

  20. Cirurgia de revascularização miocárdica: uso de enxerto bilateral de artéria torácica interna sem circulação extracorpórea Surgical myocardial revascularization: off-pump use of bilateral internal thoracic artery grafting

    Directory of Open Access Journals (Sweden)

    Walter José Gomes

    2008-01-01

    Full Text Available FUNDAMENTO: Avanços na cirurgia de revascularização miocárdica (RM introduziram benefícios adicionais, como a técnica sem uso da circulação extracorpórea (CEC e a utilização do enxerto bilateral de artéria torácica interna (ATI. A cirurgia de RM sem uso da CEC tem sido associada a melhora dos resultados imediatos e a redução da incidência de complicações perioperatórias, e o uso bilateral de enxertos de ATI oferece aumento de sobrevida e redução de eventos cardiovasculares a longo prazo. OBJETIVO: Apresentar a experiência inicial com o emprego combinado desses avanços na cirurgia de RM. MÉTODOS: Foram estudados 35 pacientes consecutivos submetidos a RM sem CEC, com enxertos bilaterais de ATIs, sendo a ATI esquerda dirigida para a artéria descendente anterior e a ATI direita anastomosada aos ramos da artéria circunflexa. As co-morbidades predominantes foram infarto do miocárdio prévio em 71,4% dos pacientes, diabetes melito em 34,2% e insuficiência renal em 14,2%. RESULTADOS: Nenhum paciente apresentou alteração do eletrocardiograma ou elevação enzimática no pós-operatório. O número de pontes por paciente variou de 2 a 4 (mediana de 3 pontes/paciente. A permanência hospitalar pós-operatória esteve entre 3 e 12 dias (média de 4,7 + 1,7 dias. Não houve casos de infecção ou deiscência esternal, mas um paciente apresentou acidente vascular cerebral no quarto dia de pós-operatório e faleceu. A duração do seguimento tardio foi de 4 a 48 meses. Não houve óbitos tardios, 31 pacientes estão assintomáticos e 3 têm angina residual. CONCLUSÃO: A combinação desses avanços técnicos na cirurgia de revascularização cirúrgica mostrou-se eficaz e pode contribuir para a melhora dos benefícios a longo prazo.BACKGROUND: Advances in surgical myocardial revascularization (MR have introduced additional benefits with the off-pump (OP technique and the use of bilateral internal thoracic artery (ITA grafting

  1. Outcomes of On-pump Coronary Artery Bypass Grafting in Patients with Metabolic Syndrome in Mashhad, Iran

    Directory of Open Access Journals (Sweden)

    Aliasghar Moeinipour

    2017-09-01

    Full Text Available Introduction: Metabolic syndrome (MS is considered as an important risk factor for advanced coronary artery disease. This condition can increase the mortality and morbidity in the patients undergoing coronary artery bypass graft (CABG surgery. The aim of the study was compared mortality and morbidity after off Pump- CABG surgery between patients with and without the Metabolic syndrome. Materials & Methods: This prospective cross-sectional study was conducted on 120 patients, who underwent off-pump CABG surgery between October 2014-October 2016. The participants were equally divided into two groups including the patients with and without MS (MS and non-MS, respectively. Results: According to the results, 68 (56.6% patients were male. Furthermore, out of the 60 participants with MS, 36 (60% cases were male. The mean ages of the MS and non-MS groups were 64.96±9.6 and 65.62±10.6 P=0.6 years, respectively. No statistically significant difference was observed between the two groups in terms of the mortality and morbidity (e.g., surgical wound infection, length of Intensive Care Unit and hospital stay, atrial fibrillation rhythm, and bleeding in the first 24 h. The intubation time in patients with Metabolic Syndrome was significantly higher than patients without Metabolic Syndrome (6.66 ± 1.97 vs 5.83 ± 1.93 respectively; P=0.007 Conclusion: Metabolic syndrome was not associated with higher mortality and morbidity after CABG surgery compare to patients without Metabolic syndrome, although patients with Metabolic syndrome had higher risk for long intubation time.

  2. Analysis on the Clinical Efficacy of Off-pump Sequential Bilateral Internal Mammary Artery Grafting Combined with Selective Arterialization of the Coronary Venous System%非体外循环双乳内动脉序贯旁路移植加选择性心中静脉动脉化手术的疗效分析

    Institute of Scientific and Technical Information of China (English)

    于洋; 顾承雄; 李海涛

    2011-01-01

    提供了新的外科治疗方法.%Objective To evaluate the clinical efficacy of sequential bilateral internal mammary artery grafting combined with selective coronary venous bypass graft (CVBG) during off-pump coronary artery bypass surgery. Methods We retrospectively analyzed the clinical data of 38 patients with diffuse right coronary arteriostenosis undergoing operation in Anzhen Hospital of Capital Medical University from March 2004 to August 2010. Based on the operation method, the patients were divided into two groups. In the CVBG group, there were 17 patients including 11 males and 6 females with an average age of 46. 1 ± 6. 2 years who underwent off-pump sequential bilateral internal mammary artery grafting combined with CVBG. In the control group, there were 21 patients including 14 males and 7 females with an average age of 45. 9 ± 5. 7 years, and they underwent the off-pump sequential bilateral internal mammary artery grafting without CVBG. Blood flow of bridged vessels was measured. The perioperative parameters including number of grafts, tracheal intubation time, hospitalization time, complications, results of echocardiography, myocardial nuclide imaging and coronary angiography were compared between the two groups of patients. Results There was no hospital mortality or complications such as cerebral events, sternal and mediastinal infections. There was statistical difference in graft number between CVBG group and control group (3. 3 it 1.1 vessels vs. 2.2 ±1.6vessels, P0. 05). Follow-up was done for all the 38 patients with a follow-up rate of 100%. Follow-up time was 3-55 months (37. 4±9. 8 months). No angina symptoms occurred in CVBG group and myocardial blood supply of inferior wall in this groups improved obviously based on the results of electrocardiogram, while there were 8 cases of angina in the control group with inferior wall myocardial ischemia and ST-T changes according to the results of electrocardiogram (P<0. 05). Heart functions

  3. 磷酸肌酸钠复合氨甲环酸对非体外循环冠状动脉旁路移植术患者心肌和血液保护作用的研究%The myocardial and blood protectivie effects of creatine phosphate sodium combined with tranexamic acid in off-pump coronary artery bypass grafting

    Institute of Scientific and Technical Information of China (English)

    李长营; 郭爱华; 张宗旺; 张学俊; 张雷; 敖虎山

    2011-01-01

    Objective To investigate whether the supplement of creatine phosphate sodium and tranexamic acid to cardioplegic solutions can improve myocardial protection and blood conservation in off-pump coronary artery bypass graft(OPCABG).Methods 280 patients undergoing OPCABG were randomly assigned to experimental group (CP with TA group, n=70 ) , creatine phosphate sodium group (CP group, n=70), tranexamic acid group (TA group, n=70) and control group (n=70). Before BACG,creatine phosphate sodium ( 100 mg/kg) combined with tranexamic acid (30 mg/kg), creatine phosphate sodium ( 100 mg/kg),tranexamic acid (30 mg/kg), and equal volume of normal saline were given intravenously in each group respectively. Venous blood samples were taken preoperatively, and at 0, 6, 12, 24, 48, 72 h, 7 d postoperatively to analyze creatine kinase isoenzyme (CK-MB), troponin (cTnI) ; Meanwhile, the amount of cumulative chest fluid drainage and inotropic agent and blood transfused were also recorded. Results The plasma concentrations of CK-MB in experimental group at 6, 12, 24, 48, 72 h postoperatively (15±6), (14±5), (16±10), (15±6) and (13±6) U/ml and the plasma concentrations of cTnI(235±1.53), (2.72±1.46), (2.64±1.32),(1.16±0.76) and (0.48±0.24) mg/L were significantly lower than those in group CP, group TA and control group (P<0.05). The amount of postoperative cumulative chest fluid at 6, 12, 24, 48, 72 h were (246±56), (420±82), (680±114), (725±126) and (730±130) ml drainage and blood transfuison in experimental group (5/70) were also significantly lower than those in other groups (P<0.05). Conclusion For patients undergoing OPCABG, creatine phosphate sodium combined with tranexamic acid plays an important role in myocardial protection and blood conservation without increasing the surgical mortality and the incidence of postoperative complications.%目的 研究在非体外循环下行冠状动脉旁路移植术(off-pump coronary artery bypass grafting,OPCABG)中应用

  4. Revascularização da artéria marginal com uso da artéria torácica interna direita pediculada retroaórtica sem circulação extracorpórea Off-pump grafting of the circumflex artery with pedicled retro-aortic right internal thoracic artery graft

    Directory of Open Access Journals (Sweden)

    Walter J. Gomes

    2005-03-01

    Full Text Available OBJETIVO: A revascularização miocárdica (RM sem circulação extracorpórea (CEC tem demonstrado proporcionar redução da mortalidade e da morbidade. Também o uso bilateral das artérias torácicas internas (ATIs pode oferecer benefício adicional, conferindo maior sobrevida. Apresentamos técnica de revascularização miocárdica utilizando ambas ATIs pediculadas, com a ATI direita (ATID, passada retroaórtica, para revascularizar os ramos da artéria circunflexa (ACx, sem CEC. MÉTODO: Foram estudados 26 pacientes submetidos à RM sem CEC, com enxertos bilaterais de ATIs, sendo a ATI esquerda (ATIE dirigida para a artéria descendente anterior (ADA e a ATID, pediculada através do seio transverso, anastomosada aos ramos da ACx. Foram analisados 21 pacientes do sexo masculino e cinco do feminino, a idade variou entre 42 e 74 anos. As co-morbidades associadas foram infarto do miocárdio prévio em 18 (69% pacientes, diabetes mellitus em 10 (38%, insuficiência renal em quatro (7,7% e AIDS em um (3,8% doente. RESULTADOS: Nenhum paciente apresentou alteração de ECG ou elevação enzimática no pós-operatório. As pontes por paciente variaram de 2 a 4 (média de 3,0 pontes/paciente. Não houve infecção ou deiscência esternal. Um paciente apresentou AVC no 4º PO e faleceu. A permanência hospitalar pós-operatória variou entre 3 e 12 dias (média 5,8±2,0 dias. A duração do seguimento tardio foi de 2 a 38 meses. Não houve eventos cardiovasculares ou óbitos tardios. CONCLUSÕES: Esta técnica, possibilitando a revascularização dos ramos da artéria circunflexa com enxerto de ATI direita pediculada, sem uso de CEC, potencialmente amplia os benefícios da cirurgia de revascularização miocárdica.OBJECTIVE: Off-pump coronary artery bypass surgery (OPCAB has been demonstrated to provide a reduction of cardiovascular events and mortality. Also, the bilateral use of the internal thoracic arteries (ITAs can offer additional benefits

  5. Revascularização do miocárdio sem circulação extracorpórea em idosos: análise da morbidade e mortalidade Off-pump myocardial revascularization in the elderly: analysis of morbidity and mortality

    Directory of Open Access Journals (Sweden)

    Ana Maria Rocha Pinto e Silva

    2008-03-01

    Full Text Available OBJETIVO: Analisar a evolução intra-hospitalar de doentes com 70 anos de idade ou mais, submetidos a revascularização do miocárdio sem circulação extracorpórea, com uso de shunt intracoronário, operados na urgência, emergência e eletivamente. MÉTODOS: Foram submetidos à cirurgia 87 doentes com idade entre 70 e 92 anos de julho de 1989 a julho de 2005. Dos 87 doentes, 50 (57,5% eram portadores de angina instável, sendo três (3,4% na vigência de infarto agudo do miocárdio. Foram operados em caráter de emergência e urgência 31 (35,6% doentes. De todo o grupo, havia 13 (14,9% doentes com infarto ocorrido em até 30 dias e 34 (39,1% com infarto ocorrido há mais de 30 dias. RESULTADOS: As complicações mais freqüentes foram: fibrilação atrial (32,2%, insuficiência cardíaca congestiva (12,6%, broncopneumonia (10,3%, sepse (3,4%, infarto agudo do miocárdio peri-operatório (2,3%, mediastinite (1,1%, acidente isquêmico transitório (1,1%, pneumotórax (1,1%. O tempo médio de intubação foi de 18,50±19,09 horas; permanência em UTI, 2,92±2,03 dias, e hospitalar, 10,55±7,16 dias. Apenas nove (10,3% doentes receberam concentrado de hemácias no pós-operatório e nenhum foi reoperado por sangramento. A mortalidade hospitalar foi de 4,6%. CONCLUSÃO: Em doentes acima de 70 anos, operados na emergência, urgência e eletivamente, a revascularização do miocárdio sem extracorpórea com shunt intracoronário apresentou adequada evolução pós-operatória e baixos índices de complicações e mortalidade em relação à população estudada.OBJECTIVE: To analyze the in-hospital outcome of elderly patients aged 70 years and older who underwent off-pump coronary artery bypass graft surgery with an intraluminal shunt in urgent, emergent, and elective coronary revascularizations. METHODS: From July 1989 to July 2005, we analyzed 87 patients ranging in age from 70 to 92 years. Of the 87 patients enrolled, 50 (57.5% patients had

  6. Agreement between cardiac index measured with FloTrac-Vigileo system and pulmonary artery catheter in patients undergoing off-pump coronary artery bypass grafting%非体外循环冠状动脉旁路移植术患者FloTrac-Vigileo系统与肺动脉导管技术监测心指数的一致性

    Institute of Scientific and Technical Information of China (English)

    杜伯祥; 史宏伟; 宋杰; 葛亚力

    2011-01-01

    目的 评价非体外循环冠状动脉旁路移植术患者FloTrac- Vigileo( FV)系统与肺动脉导管(PAC)技术监测心指数(CI)的一致性.方法 拟行非体外循环冠状动脉旁路移植术患者43例,年龄53~75岁,身高150~ 183 cm,体重46~100 kg,ASA分级Ⅱ或Ⅲ级.静脉注射咪达唑仑、舒芬太尼、异丙酚和罗库溴铵行麻醉诱导,麻醉维持:静脉输注异丙酚和瑞芬太尼,间断静脉注射阿曲库铵.于锯胸骨后至搭桥开始前和搭桥完成后至闭合胸骨前,吸入1 MAC七氟醚,其余时间不吸入七氟醚.采用FV系统和PAC技术监测CI.于锯胸骨后未吸入七氟醚时、吸入七氟醚5、15 min时,冠状动脉搭桥完成后未吸入七氟醚时、吸人七氟醚5、15 min时记录两种方法监测的CI数据对,进行一致性分析.结果 FV系统和PAC技术测定CI共计258次配对数据,配对数据平均值的均数(2.8±0.6)L·min- ·m-2.配对数据差值的均数(平均偏差)为0.23 L· min-1·m-2,一致性限度(- 0.57,1.02)L·min-1·m-2,百分误差为28.6%,Kappa系数为0.546.结论 FV系统与PAC技术监测CI的一致性尚可,可替代PAC技术用于非体外循环冠状动脉旁路移植术患者CI的监测.%Objective To determine ff the cardiac index (CI) measured with FloTrac-Vigileo system agrees with that measured with pulmonary artery catheter (PAC).Methods Forty-three ASA Ⅱ or Ⅲ patients aged 53-75 yr weighing 46-100 kg undergoing off-pump coronary artery bypass grafting were included in this study.Anesthesia was induced with midasolam,sufentunil,propofol and rocuronium and maintained with propofol,remifentanil and atracurium.One MAC sevoflurane was inhaled at breast bone splitting and closing.CI was measured with FloTrac-Vigileo system and PAC before,and at 5,15 min of sevoflurane inhalation and recorded.All data were compared by Bland-Altman analysis and with kappa coefficient for agreement and percentage error was calculated.Results Bland-Altman comparison

  7. On-pump fibrillating heart mitral valve replacement with the SAPIEN™ XT transcatheter heart valve.

    Science.gov (United States)

    Ferrari, Enrico; Niclauss, Lars; Locca, Didier; Marcucci, Carlo

    2014-04-01

    In some high-risk patients, standard mitral valve replacement can represent a challenging procedure, requiring a risky extensive decalcification of the annulus. In particular, high-risk redo patients and patients with a previously implanted transcatheter aortic valve, who develop calcific mitral disease, would benefit from the development of new, minimally invasive, transcatheter or hybrid techniques for mitral valve replacement. In particular, mixing transcatheter valve therapies and well-established minimally invasive techniques for mitral replacement or repair can help in decreasing the surgical risk and the technical complexity. Thus, placing transcatheter, balloon-expandable Sapien™ XT stent-valves in calcified, degenerated mitral valves through a right thoracotomy, a left atriotomy and on an on-pump fibrillating heart, represents an attractive alternative to standard surgery in redo patients, in patients with concomitant transcatheter aortic stent-valves in place and in patients with a high-risk profile. We describe this hybrid technique in detail.

  8. Temporary diabetes insipidus in 2 men after on-pump coronary artery bypass grafting.

    Science.gov (United States)

    Uyar, Ihsan Sami; Sahin, Veysel; Akpinar, Besir; Yurtman, Volkan; Abacilar, Feyzi; Okur, Faik Fevzi; Ates, Mehmet

    2013-01-01

    Many complications have been reported after cardiopulmonary bypass. A common physiologic change during the early postoperative period after cardiopulmonary bypass is increased diuresis. In patients whose urine output is increased, postoperative diabetes insipidus can develop, although reports of this are rare. We present the cases of 2 patients who underwent on-pump coronary artery bypass grafting (with cardiopulmonary bypass). Each was diagnosed with diabetes insipidus postoperatively: a 54-year-old man on the 3rd day, and a 66-year-old man on the 4th day. Each patient recovered from the condition after 6 hours of intranasal therapy with synthetic vasopressin (antidiuretic hormone). The diagnosis of diabetes insipidus should be considered in patients who produce excessive urine early after cardiac surgery in which cardiopulmonary bypass has been used.

  9. Damages on pumps and systems the handbook for the operation of centrifugal pumps

    CERN Document Server

    Merkle, Thomas

    2014-01-01

    Damage on Pumps and Systems. The Handbook for the Operation of Centrifugal Pumps offers a combination of the theoretical basics and practical experience for the operation of circulation pumps in the engineering industry. Centrifugal pumps and systems are extremely vulnerable to damage from a variety of causes, but the resulting breakdown can be prevented by ensuring that these pumps and systems are operated properly. This book provides a total overview of operating centrifugal pumps, including condition monitoring, preventive maintenance, life cycle costs, energy savings and economic aspects. Extra emphasis is given to the potential damage to these pumps and systems, and what can be done to prevent breakdown. Addresses specific issues about pumping of metal chips, sand, abrasive dust and other solids in fluidsEmphasis on economic and efficiency aspects of predictive maintenance and condition monitoring Uses life cycle costs (LCC) to evaluate and calculate the costs of pumping systems

  10. The risk factors associated with intraoperative acute cardiac decompensation in patients undergoing off-pump coronary artery bypass grafting%非体外循环冠状动脉旁路移植术患者术中急性心功能失代偿的危险因素

    Institute of Scientific and Technical Information of China (English)

    董秀华; 卢家凯; 卿恩明; 王义军; 王学勇

    2010-01-01

    目的 筛选非体外循环冠状动脉旁路移植术(OPCABG)患者术中发生急性心功能失代偿的危险因素.方法 选择本院2007年11月至2009年2月行OPCABG的患者2379例,记录术前、术中与急性心功能失代偿可能有关的因素.根据是否发生急性心功能失代偿,分为2组:急性心功能失代偿组和非急性心功能失代偿组.采用1ogistic多元回归分析,筛选发生急性心功能失代偿的危险因素.结果 术中发生急性心功能失代偿368例(发生率15.5%),无一例患者死亡.logistic多元回归分析显示,室壁瘤、术中房颤、术中频发性室性期前收缩、术前射血分数<40%、术前室性期前收缩、合并瓣膜病、心肌梗死史、入室心动过速、急诊手术、左主干病变为术中发生急性心功能失代偿的危险因素.结论 术前合并室壁瘤、瓣膜病变、左主干病变、心肌梗死史、术前室性期前收缩、射血分数<40%,术中房颤、频发性室性期前收缩、入室心动过速和急诊手术为OPCABG患者术中发生急性心功能失代偿的危险因素.%Objective To identify the risk factors associated with intraoperative acute cardiac decompensation in patients undergoing off-pump coronary artery bypass grafting (OPCABG). Methods From November 2007 to February 2009, 2379 OPCABGs were performed in our hospital. The possible risk factors associated with intraoperative cardiac decompensation were retrospectively analyzed. The preoperative patient demographics and intraoperative characteristics were correlated with intraoperative acute cardiac decompensation.The possible risk factors included sex, age, body weight, cardiac function (NYHA classification), the associated diseases (hypertension, diabetes mellitus, liver-kidney dysfunction), history of myocardial infarct, ventricular aneurysm, preoperative treatment with β-blocker and/or calcium channel blocking agent, ventricular extrasystole,atrial fibrillation, duration of

  11. Change in right ventricular function during off-pump coronary artery bypass graft surgery in patients with different ejection fraction%不同射血分数患者非体外循环冠状动脉旁路移植术中右心功能变化

    Institute of Scientific and Technical Information of China (English)

    王长卿

    2012-01-01

    Objective To study the right ventricular (RV) function during off-pump coronary artery bypass graft COPCABG) surgery in patients with different ejection fraction(EF). Methods Fifty ASA E or DI patienis scheduled for OPCABG were randomly divided into two groups,group EF≥50% (n = 30), group EF≤35% (n = 20). A thermodilution pulmonary artery catheter was inserted after anesthesia induction. The values of CVP, mean pulmonary arterial pressure CMPAP), pulmonary arterial wedge pressure (PAWP), cardiac output index (CD, right ventricular ejection fraction (RVEF) and right ventricular end-diastolic volume index (RVEDVI) were measured at the points of immediate epicardium opening (baseline), 5 nun after the heart was positioned for each coronary anastomosis (Included left anterior descending( LAD) artery, left circumflex (LCX) artery, posterior descending artery (PDA)) and after the sternum closing. Results CVP. MPAP and PAWP increased during anastomoses of each coronary artery(P<0. 05). During anastomosis of the LCX artery and PDA, Cl and RVEF in both groups were significantly reduced(P<0. 05), RVEDVI in group EF≥50% decreased and increased in group EF≤35%(P<0. 05). Compared with group EF≤35%, RVEF in group EF≥50% increased significantly during anastomoses of LCX and PDA and after sternum closing, RVEDVI decreased during anastomoses of LCX and PDA(P<0. 05). Qmdusion The displacement of beating heart for positioning during anastomosis of the graft to I.CX artery and PDA caused significant derangement of RV function. The change of RV function was different in patients with different EF.%目的 研究不同射血分数患者非体外循环冠状动脉旁路移植术(OPCABG)术中右心功能变化规律.方法 选择50例择期行OPCABG的患者,ASAⅡ或Ⅲ级,其中EF≥50%组30例,EF≤35%组20例,麻醉诱导后放置肺动脉导管,分别记录开心包后(基础值)、前降支(LAD)搭桥、回旋支(LCX)搭桥、后降

  12. Heart-type fatty acid binding protein in the early diagnosis of myocardial infarction after off-pump coronary artery bypass%心肌型脂肪酸结合蛋白早期快速诊断OPCAB术后心肌梗死

    Institute of Scientific and Technical Information of China (English)

    孟冬梅; 李培军; 刘子后; 李杰; 孙静; 郭志刚; 刘建实

    2012-01-01

    目的 探讨心肌型脂肪酸结合蛋白(H-FABP)对非体外循环不停跳冠状动脉旁路移植术(OPCAB)术后心肌梗死的早期快速诊断价值.方法 2009年3月至7月,59例患者行首次单纯OPCAB.根据围手术期肌酸激酶同工酶(CK-MB)、心肌肌钙蛋白Ⅰ(cTnI)值及心电图、超声心动图的变化将患者分为正常组(Ⅰ组)、心肌损伤组(Ⅱ组)和心肌梗死组(Ⅲ组),分析各组H-FABP、CK-MB、cTnI含量的变化,并应用ROC曲线分析H-FABP诊断术后急性心肌梗死的诊断截断点和应用价值.结果 Ⅲ组的H-FABP水平显著高于Ⅱ组及Ⅰ组(P<0.01),H-FABP峰值出现时间早(人ICU 2 h即达到高峰),维持时间短(入ICU 4 h即开始下降),术后1天回到基线水平.经ROC曲线检验,以H-FABP 22μg/L为心肌梗死的诊断截断点,入ICU即刻诊断灵敏度为90.9%,特异性为77.1%.入ICU 2 h的H-FABP值灵敏度为72.7%,特异性为75.0%.结论 H-FABP有助于OPCAB术后心肌梗死的早期快速诊断.%Objective To evaluate the early diagnostic value of Heart-type fatty acid-binding protein(H-FABP) for myocardial infarction in patients post off-pump coronary artery bypass (OPCAB).Methods Between March 2009 and July 2009,59 patients had been undergone OPCAB for the first time.They were divided into 3 groups (normal group,myocardial injury group and myocardial infarction group) by myocardial-bound creatiue kinase (CK-MB) 、cardiac troponio Ⅰ (cTnI) 、electrocardiogram (ECG) and echocardiogram.Serial blood samples were taken during perioperation to quantify blood levels of H-FABP,CK-MB,cTnI.Results The average H-FABP value for the patients in the myocardial infarction group is higher than the others ( P < 0.01 ).H-FABP reached the peak valve at 2 hours and decreased at 4 hours after the patients arrived at ICU.H-FABP got back to the baseline one day postoperation.Receiver operating characteristic curves( ROC curve) demonstrated that H-FABP had greater diagnostic

  13. Effect of dexmedetomidine on hemodynamics and stress reaction in patients undergoing off-pump coronary artery bypass grafting%右美托咪定对非体外循环冠状动脉旁路移植术患者血流动力学及应激反应的影响

    Institute of Scientific and Technical Information of China (English)

    张子斌; 高成杰; 王瑞雯; 王惠霞; 徐鲁峰

    2015-01-01

    Objective To evaluate the effect of dexmedetomidine on hemodynamic and stress reaction in patients undergoing off-pump coronary artery bypass grafting (OPCABG).Methods Sixty patients,ASA Ⅱ or Ⅲ,aged 45 y-65 y,weighting 55 kg-86 kg,scheduled for OPCABG,were randomly assigned to two groups:the group dexmedetomidine (group D,n=30) and the group control (group C,n=30).Patients in group D received an initial bolus dose of dexmedetomidine (0.5 μg/kg) over 10 min before anesthesia induction followed by a continuous infusion of 0.5 μg ·kg-1 ·h-1 until the end of the operation.Group C received equal volume of normal saline.Hemodynamic parameters were recorded before injection (T0),after initial bolus dose infusion (T1),when tracheal intubation (T2),sternotomy (T3),at anastomosis of left anterior descending (T4),at anastomosis of right coronary artery or posterior descending artery (T5),at anastomosis of left circumflex cornary artery or diagonal artery (T6),at anastomosis of aortic (T7),at 10 min after reestablishment of coronary blood flow (T8),end of operation (T9) and after tracheal extubation (T10).The stability of circulation was evaluated and consumption of fentany in both groups was recorded.Concentrations of blood glucose,cortisol,norepinephrine and epinephrine were measured at T0,T3,T8-T10.Results There was significant difference between group D and group C in heart rate (HR) at T1-T10,mean arterial pressure (MAP) at T1-T3,T9,T10,mean pulmonary artery pressure (MPAP) at T1-T3,T9,T10,system vascular resistance index (SVRI) at T1-T10,pulmonary vascular resistance index (PVRI) at T1-T10,cardiac index (CI) at T7-T8,left ventricular stroke work index (LVSWI) and right ventricular stroke work index (RVSWI)at T7-T8 (P<0.05).The incidences of sinus tachycardia and hypertension in group D were significantly reduced than in group C (P<0.05).In both groups,glucose (Glu),cortisol (Cor),noradrenaline (NE) and epinephrine (E) increased significantly at T3,T8-T10 (P

  14. 主动脉内球囊反搏在高危患者非体外循环冠状动脉旁路移植术中的应用%Application of Intra-aortic Balloon Pump for High-risk Patients before Off-pump Coronary Artery Bypass Grafting

    Institute of Scientific and Technical Information of China (English)

    丁文军; 魏强; 孙勇新; 史昀青; 王春生

    2013-01-01

    目的 分析行非体外循环冠状动脉旁路移植术(off-pump coronary artery bypass grafting,OPCAB)的高危患者术前应用主动脉内球囊反搏(intraaortic balloon pump,IABP)的治疗效果,总结IABP的应用及撤机指征.方法 回顾性分析自2008年1月至2011年7月复旦大学附属中山医院102例高危冠心病患者[IABP组,男71例,女31例;年龄(63.0±8.2)岁]在OPCAB术前置入IABP治疗的临床资料,另外选择100例未于术前置入IABP的患者作为对照[对照组,男55例,女45例;年龄(64.1±9.5)岁].监测两组患者手术后有创动脉收缩压(SABP)、有创平均动脉压(MABP)、机械辅助通气时间、住ICU时间、并发症发生情况、IABP辅助时间、围术期死亡等.术后3个月复查心脏超声心动图检测左心室射血分数(LVEF).结果 IABP组患者术后SABP[(95.3±12.2) mm Hgvs.(80.1±11.7) mm Hg; t=8.440,P=0.000]、MABP[(78.9±13.5) mm Hg vs.(52.3±15.1)mm Hg; t=12.410,P=0.000]明显高于对照组;机械辅助通气时间、住ICU时间、正性肌力药物辅助时间较对照组短;室性心律失常、低心排血量、围术期心肌梗死和围术期肾功能不全血液透析的发生较对照组少;围术期死亡率低于对照组[5.9% (6/102) vs.17.0%(17/100),x2=6.180,P=0.020].IABP组随访96例,对照组随访83例,随访时间均为3个月.术后3个月时心脏超声心动图提示IABP组LVEF显著高于对照组(45.3%±12.0% vs.39.1%±8.2%,t=3.950,P=0.000).结论 对具有高危因素的OPCAB患者术前预防性置入IABP、且把握好撤机时机,可降低手术风险,明显提高手术效果,加快患者术后恢复,改善心功能,减少并发症的发生,降低围术期病死率.%Objective To analyze clinical outcomes of intra-aortic balloon pump (IABP) application for high-risk patients before undergoing off-pump coronary artery bypass grafting (OPC AB), and summarize our experience and weaning indications of IABP. Methods We retrospectively analyzed

  15. Supported employment: randomised controlled trial*

    Science.gov (United States)

    Howard, Louise M.; Heslin, Margaret; Leese, Morven; McCrone, Paul; Rice, Christopher; Jarrett, Manuela; Spokes, Terry; Huxley, Peter; Thornicroft, Graham

    2010-01-01

    Background There is evidence from North American trials that supported employment using the individual placement and support (IPS) model is effective in helping individuals with severe mental illness gain competitive employment. There have been few trials in other parts of the world. Aims To investigate the effectiveness and cost-effectiveness of IPS in the UK. Method Individuals with severe mental illness in South London were randomised to IPS or local traditional vocational services (treatment as usual) (ISRCTN96677673). Results Two hundred and nineteen participants were randomised, and 90% assessed 1 year later. There were no significant differences between the treatment as usual and intervention groups in obtaining competitive employment (13% in the intervention group and 7% in controls; risk ratio 1.35, 95% CI 0.95–1.93, P = 0.15), nor in secondary outcomes. Conclusions There was no evidence that IPS was of significant benefit in achieving competitive employment for individuals in South London at 1-year follow-up, which may reflect suboptimal implementation. Implementation of IPS can be challenging in the UK context where IPS is not structurally integrated with mental health services, and economic disincentives may lead to lower levels of motivation in individuals with severe mental illness and psychiatric professionals. PMID:20435968

  16. How much heparin do we really need to go on pump? A rethink of current practices.

    LENUS (Irish Health Repository)

    Shuhaibar, M N

    2012-02-03

    OBJECTIVES: Patients undergoing myocardial revascularisation using extracorporeal circulation require heparin anticoagulation. We aimed to evaluate the effect of reducing heparin dosage on target activated clotting time (ACT) and postoperative blood loss. METHODS: In a prospective randomised trial, 195 patients undergoing isolated primary CABG were randomised into four groups A, B, C, and D receiving an initial heparin dosage of 100, 200, 250 and 300 iu\\/kg, respectively. Extra incremental heparin (50 iu\\/kg) was added if required to achieve a target ACT of 480 s before initiating cardiopulmonary bypass. Postoperative blood loss was measured from the time of heparin reversal to drain removal 24h later. RESULTS: Target ACT was achieved in 0, 63, 68.3 and 82.4% of patients in groups A, B, C and D, respectively, after the initial dose of heparin. In group B, of those not achieving target act a single increment of heparin was sufficient to achieve target ACT in further 18.6%. The mean ACT after the initial dose in groups B, C and D was 482.9, 519 and 588 s, respectively (P<0.05). Postoperative blood loss in millilitre per kilogram was directly proportional to preoperative heparin dose. CONCLUSIONS: Patients receiving lower dose of heparin has lower postoperative blood loss. Of those achieving the target ACT, group B was significantly the closest to the target ACT. A starting dose of 200 iu\\/kg of heparin and if necessary one 50 iu\\/kg increment achieved target ACT in 81.5% of patients. The added benefit of significant drop in postoperative blood loss is evident.

  17. Surgical correction of ruptured aneurysms of the sinus of Valsalva using on-pump beating-heart technique

    Directory of Open Access Journals (Sweden)

    Lin Hui

    2010-05-01

    Full Text Available Abstract Background Rupture of aneurysms of the sinus of Valsalva results in abrupt onset of congestive heart failure. On-pump beating-heart surgery may reduce cardiac impairment by maintaining coronary blood flow and avoiding cardioplegia. Herein, we report the operative correction of thirty-one patients of ruptured aneurysms of the sinus of Valsalva, using the on-pump beating-heart technique. Methods Thirty-one patients with ruptured aneurysms of the sinus of Valsalva underwent operative corrections using the on-pump beating-heart technique. In patients with fistula diameter less than 1 cm and no aortic regurgitation, the aorta was unclamped throughout cardiopulmonary bypass(CPB while receiving antegrade heart perfusion. In remainder of patients, retrograde perfusion was used. Results After intracardiac manipulation was complete and the nasopharyngeal temperature was raised to 36-37°C, the patients were smoothly weaned off CPB. There were no early or late postoperative deaths. All patients were in New York Heart Association functional class I at follow-up (range, 0.5-1 year. Mild-to-moderate aortic valve regurgitation was observed in one patient. No recurrence of the left-to-right shunt from ruptured aneurysms of the sinus of Valsalva was observed. Conclusions Beating heart on pump allows adequate examination of the aortic lesion under near-physiologic conditions, allows decrease in ischemia-reperfusion injury and potentially decreases the risk of serious or fatal rhythm disturbances. On-pump beating-heart technique for repair of ruptured aneurysm of sinus of Valsalva is feasible and promising. Antegrade heart perfusion is suitable for patients with a fistula diameter

  18. Influence of Preoperative Cerebrovascular Evaluation on Neurological Complications Following Off -Pump Coronary Artery Bypass Grafting%术前脑血管评估对非体外循环冠状动脉旁路移植术后神经系统并发症的影响研究

    Institute of Scientific and Technical Information of China (English)

    许保磊; 毕齐; 陈明盈; 骆迪; 乔秋博

    2016-01-01

    目的 探讨非体外循环冠状动脉旁路移植术 (OPCABG) 后神经系统并发症 (NC) 的发生率及其危险因素, 并明确术前脑灌注异常、 颅脑CT血管成像 ( CTA) 狭窄情况与术后NC的关系. 方法 选取2010年7月—2012年7月北京安贞医院心脏外科连续收治的具有行OPCABG手术指征患者556例, 术前均采用320排动态容积CT评估脑灌注情况, 采用颅脑CTA评估脑血管狭窄情况. 所有患者分别于术前和术后1周进行NC评估, 根据OPCABG后是否发生NC分为NC组 (n=118) 和非NC组 (n=438), 分析脑灌注异常、 颅脑CTA狭窄情况对术后NC的影响. 结果术后 NC 总发生率为 21.2% ( 118/556 ) , 其中脑梗死为1.3% ( 7/556 ) , 缺血低氧性脑病 ( HIE ) 为 2.9%(16/556), 谵妄为1.1% (6/556), 术后认知功能障碍 (POCD) 为11.9% (66/556), 焦虑、 抑郁状态为6.0%(33/556). NC组脑血管病史、 脑灌注异常比例及颅脑CTA狭窄程度均高于非NC组, 差异有统计学意义 ( P<0.05).多因素Logistic回归分析结果显示, 脑血管病史、 术前脑灌注异常为术后NC发生的独立影响因素 ( P<0.05). 多因素Logistic回归分析结果亦显示, 与颅脑CTA 无狭窄患者相比, 重度狭窄患者术后发生NC 的OR ( 95%CI ) 为2.25 (1.35, 3.77), P<0.05. NC组颞叶、 枕叶、 基底核区达峰时间 (TTP) 差值, 枕叶、 基底核区对比剂平均通过时间(MTT) 差值均大于非NC组, 差异有统计学意义 (P<0.05). 结论 OPCABG后NC发生率较高, 脑血管病史、 术前脑灌注异常为术后NC的独立危险因素, 随着颅脑CTA狭窄程度增加, 术后NC的发生风险逐渐增加.%Objective To investigate the incidence and risk factors of neurological complications ( NC) following off-pump coronary artery bypass grafting (OPCABG) .Methods We recruited 556 patients who were admitted into Department of Cardiac Surgery of Beijing Anzhen University and underwent OPCABG there from July 2010 to July 2012.Before

  19. Analysis of risk factors for postoperative atrial fibrillation in elderly patients with coronary heart disease after off-pump coronary artery bypass grafting surgery%老年冠心病患者非体外循环冠状动脉旁路移植术后心房颤动的危险因素分析

    Institute of Scientific and Technical Information of China (English)

    权晓强; 程兆云; 赵健; 王圣; 孙俊杰; 李建强

    2015-01-01

    Objective To investigate certain risk factors for postoperative atrial fibrillation (AF) in elderly patients with coronary heart disease after off-pump coronary artery bypass grafting (OPCAB)surgery in order to provide a basis for the prevention and treatment of AF after OPCAB.Methods A total of 139 elderly patients with coronary heart disease who had undergone OPCAB surgery in our hospital were collected as research subjects and divided into the AF group and the nonAF group according to the occurrence of AF after operation.The patients' general information and clinical data were retrospectively analyzed.Risk factors for AF after OPCAB surgery in elderly patients with coronary heart disease were investigated.Results The incidence of AF after OPCAB was 15.8% in elderly patients with coronary heart disease.There were no statistical differences in gender,history of diabetes,history of myocardial infarction,preoperative β-blocker usage,number of coronary artery lesions,or operation time between the AF group and the non-AF group (P>0.05).The percentage of patients who were of older age (t=9.960) or had a left ventricular ejection fraction ≥40% (x2=4.942),a left atrial diameter ≥40 mm (x2 =4.491),a history of hypertension (x2 =12.357),dopamine medication after operation (x2 =8.511),or a bypass vessel count≥ 3 (x2 =5.385) was higher in the AF group than in the non-AF group (all P<0.05).Logistic regression analysis showed that age,history of hypertension,dopamine medication after operation,left atrial diameter and bypass vessel count were the risk factors for AF after OPCAB surgery in elderly patients with coronary heart disease (OR 3.080,2.435,2.465,3.593,and 1.921,respectively,P<0.05 for all).Conclusions The incidence of AF after OPCAB is high in elderly patients with coronary heart disease and is affected by many risk factors.These risk factors should be assessed before surgery so that appropriate prevention measures can be taken.%目的 探讨老年

  20. The clinical effects of dexmedetomidine during anesthetic induction for patients undergoing off-pump coronary artery bypass grafting%右旋美托咪啶麻醉诱导用于冠状动脉旁路移植术临床效果分析

    Institute of Scientific and Technical Information of China (English)

    赵丽云; 王辉; 徐源; 刘醒帅; 卿恩明

    2011-01-01

    Objective : To evaluate the clinical effects of dexmedetomidine combined with other anesthetics during anesthetic induction for patients undergoing off-pump coronary artery bypass grafting( OPCAB) .Methods :Thirty-six patients scheduled for OPCABG were randomly devided into group dexmedetomidine( group D) and control group ( group C) . Group D received dexmedetomidine 1. o μg/kg over lO min , and group C received placebo saline before anesthetic induction. The two group received the same method of anesthetic induction. Hemodynamic variables were recorded at pre-induction (T1) , intubation (T2) , after tracheal intubation (T3) . Pain was measured using visual analog scale ( VAS) , Remesay sedation scale was evaluated for sadition.The duration of tracheal intubation and intensive care unit, hospital length of stay and complications were recorded. Also, total sufentanil dosage and extra morphine dosage were calculated either. Results : Mean artery pressure(MAP) at intubation was significantly higher in Group D than Group C,The percent increase in MAP and HR due to tracheal intubation in Group D was significantly lower than that of Group C ( P < 0. 05) . There was no differences with VAS of 15min , 4h and 24h after tracheal extubation. No differences between groups were noted for duration of tracheal intubation, ICU and hospital length of stay, total sufentanil dosage, sedation, and postoperative nausea and vomit. Conclusion : Dexmedetomidine can suppresses the decrease in blood pressure due to anesthetic induction and also blunts the cardiovascular response to tracheal intubation. Provide better pain control, indicating that Dexmedetomidine can provide superior clinical effects in patients undergoing OPCAB.%目的:对比研究麻醉诱导时联合应用右旋美托咪啶(dexmedetomidine)在冠状动脉旁路血管移植术(OPCABG)的临床效果.方法:36例拟行OPCABG的患者随机分为右旋美托咪啶组(D组)与对照组(C组).D组于麻醉诱导前给

  1. Revascularização total do miocárdio sem circulação extracorpórea em pacientes com disfunção ventricular esquerda Off-pump total myocardial revascularization in patients with left ventricular dysfunction

    Directory of Open Access Journals (Sweden)

    Rodrigo Milani

    2007-07-01

    Full Text Available OBJETIVO: Avaliar a operação para revascularização do miocárdio sem circulação extracorpórea (CEC em pacientes com importante disfunção ventricular esquerda. MÉTODOS: Foram submetidos a operação para revascularização do miocárdio sem CEC, 405 pacientes com fração de ejeção (FE abaixo de 35%. A operação foi realizada com auxílio de estabilizador por sucção e ponto de LIMA. As anastomoses distais foram feitas primeiro. RESULTADOS: Foram avaliados 405 pacientes com idade média de 63,4±9,78 anos, sendo 279 do sexo masculino (68,8%. Quanto a fatores de risco, 347 eram hipertensos, 194 tabagistas, 202 dislipidêmicos e 134 diabéticos. Encontravam-se em classe funcional III e IV 260 pacientes. Eram renais crônicos 20 pacientes, em programa de diálise. Foram operados em caráter de emergência 51 pacientes, e 33 já apresentavam operação prévia. A FE média foi de 27,2±3,54%. O EUROSCORE médio foi de 8,46±4,41. O número médio de anastomoses foi 3,03±1,54 por paciente. Necessitaram de balão intraórtico após a indução anestésica 49 pacientes (12%, e 73 (18% necessitaram de suporte inotrópico no período transoperatório. Quanto a complicações, 2 (0,49% apresentaram insuficiência renal, 2 apresentaram mediastinite (0,49%, 7 (1,7% necessitaram de reoperação por sangramento, 5 (1,2% apresentaram infarto agudo do miocárdio e 70 (17,3% apresentaram fibrilação atrial. Houve 18 óbitos (4,4%. CONCLUSÃO: Com base nesses dados, concluímos que a operação para revascularização do miocárdio sem circulação extracorpórea em pacientes com disfunção ventricular esquerda é segura e eficaz, sendo uma alternativa para pacientes de alto risco. Os resultados obtidos foram superiores ao previsto pelo EUROSCORE.OBJECTIVE: To assess off-pump myocardial revascularization in patients with significant left ventricular dysfunction. METHODS: Four hundred and five patients with an ejection fraction less than 35

  2. Implante transapical de endoprótese valvada balão-expansível em posição aórtica sem circulação extracorpórea Off-pump transapical balloon-expandable aortic valve endoprosthesis implantation

    Directory of Open Access Journals (Sweden)

    Diego Felipe Gaia

    2009-06-01

    ão.OBJECTIVE: The aortic valve replacement is a routine procedure, and involves replacement of the native valve/prosthesis. In most of the patients who undergo such procedure the risk is acceptable, but in some cases, such risk can justify contraindication. The minimally invasive transcatheter aortic valve implantation without cardiopulmonary bypass (CPB has been shown to be viable, with lower morbidity and mortality. The aim of this study was to develop a catheter-mounted aortic bioprosthesis for implantation without CPB. METHODS: After developing in animals, three patients with high EuroSCORE underwent implantation. Case 1: patients with bioprosthesis dysfunction; Case 2: severe aortic stenosis; Case 3: dysfunction of aortic bioprosthesis. After minithoracotomy and under echocardiographic and fluoroscopic control, a balloon catheter was placed on aortic position and inflated. After, a second balloon with valved endoprosthesis was positioned and released under high ventricular rate. Echocardiographic and angiographic controls were performed and the patients were referred to ICU. RESULTS: In the first case, implantation without CPB was possible with appropriate results. The patient evolved with improvement of ventricular function. After, this patient developed bronchopneumonia, tracheoesophageal fistula and died due to mediastinitis. Autopsy confirmed proper valve positioning and leaflets preservation. The second case showed the device migration after inflation of the balloon, with the need for urgent median sternotomy, CPB and conventional valve replacement. This patient evolved well and was discharged from the ICU on the 14th postoperative day without complications. This patient developed respiratory infection, septic shock and died on the 60th postoperative day. The patient from the third case underwent successful implantation. CONCLUSION: The off-pump transapical implantation of catheter-mounted bioprosthesis was shown to be a feasible procedure. Technical details and learning

  3. Fast Track Extubation In Adult Patients On Pump Open Heart Surgery At A Tertiary Care Hospital.

    Science.gov (United States)

    Akhtar, Mohammad Irfan; Sharif, Hasanat; Hamid, Mohammad; Samad, Khalid; Khan, Fazal Hameed

    2016-01-01

    Fast-track cardiac surgery programs have been established as the standard of cardiac surgical care. Studies have shown that early extubation in elective cardiac surgery patients, including coronary and non-coronary open-heart surgery patients does not increase perioperative morbidity and mortality. The objective of this observational study was to determine the success and failure profile of fast track extubation (FTE) practice in adult open-heart surgical patients. The study was conducted at cardiac operating room and Cardiac Intensive Care Unit (CICU) of a tertiary care hospital for a period of nine months, i.e., from Oct 2014 to June-2015. All on pump elective adult cardiac surgery patients including isolated CABG, isolated Valve replacements, combined procedures and aortic root replacements were enrolled in the study. Standardized anesthetic technique was adopted. Surgical and bypass techniques were tailored according to the procedure. Success of Fast track extubation was defined as extubation within 6 hours of arrival in CICU. A total of 290 patients were recruited. The average age of the patients was 56.3±10.5 years. There were 77.6% male and 22.4% female patients. Overall success rate was 51.9% and failure rate was 48.1%. The peri-operative renal insufficiency, cross clamp time and CICU stay (hours) were significantly lower in success group. Re-intubation rate was 0.74%. The perioperative parameters were significantly better in success group and the safety was also demonstrated in the patients who were fast tracked successfully. To implement the practice in its full capacity and benefit, a fast track protocol needs to be devised to standardize the current practices and to disseminate the strategy among junior anaesthesiologists, perfusionists and nursing staff.

  4. Hemodynamic effects of peri-operative statin therapy in on-pump cardiac surgery patients

    Directory of Open Access Journals (Sweden)

    Hinz Jose

    2012-07-01

    Full Text Available Abstract Background Peri-operative statin therapy in cardiac surgery cases is reported to reduce the rate of mortality, stroke, postoperative atrial fibrillation, and systemic inflammation. Systemic inflammation could affect the hemodynamic parameters and stability. We set out to study the effect of statin therapy on perioperative hemodynamic parameters and its clinical outcome. Methods In a single center study from 2006 to 2007, peri-operative hemodynamic parameters of 478 patients, who underwent cardiac surgery with cardiopulmonary bypass, were measured. Patients were divided into those who received perioperative statin therapy (n = 276; statin group and those who did not receive statin therapy (n = 202; no-statin group. The two groups were compared together using Kolmogorov-Smirnov-Test, Fisher’s-Exact-Test, and Student’s-T-test. A p value  Results There was no significant difference in the preoperative risk factors. Onset of postoperative atrial fibrillation was not affected by statin therapy. Extended hemodynamic measurements revealed no significant difference between the two groups, apart from Systemic Vascular Resistance Index (SVRI . The no-statin group had a significantly higher SVRI (882 ± 206 vs. 1050 ± 501 dyn s/cm5/m2, p = 0.022. Inotropic support was the same in both groups and no significant difference in the mortality rate was noticed. Also, hemodynamic parameters were not affected by different types and doses of statins. Conclusions Perioperative statin therapy for patients undergoing on-pump coronary bypass grafting or valvular surgery, does not affect the hemodynamic parameters and its clinical outcome.

  5. Organ hierarchy during low blood flow on-pump: a randomized experimental positron emission tomography study

    DEFF Research Database (Denmark)

    Thomassen, Sisse Anette; Kjærgaard, Benedict; Frøkiær, Jørgen;

    ; normothermic CPB with a blood flow of 2.5 L/min/m2 for one hour followed by a randomisation to a blood flow of either 2.0 L/min/m2 (Group I) or 1.5 L/min/m2 (Group II) for another hour and finally one hour with blood flow of 2.5 L/min/m2. Regional tissue perfusion of brain, liver, kidney, and muscle...... indicates existence of an organ hierarchy with persevered perfusion of the brain but affected muscle tissue perfusion in in both Groups of suboptimal blood flow. The finally results will be ready for presentation at DASAIM 2014 in November. Non-parametric statistical method will be used. Discussion To our...... knowledge this is the first study investigating organ hierarchy with dynamic PET-CT during profound systemic ischemia due to suboptimal blood flows during normothermic CPB. References 1. Murphy JM, Hessel II EA, Groom RC. Optimal perfusion during cardiopulmonary bypass: an Evidence-based approach. Anesth...

  6. Effects of Shenfu injection on hemodynamics and oxygen metabolism in off-pump coronary artery bypass grafting%非体外循环冠脉搭桥术中参附注射液对血流动力学和氧代谢的影响

    Institute of Scientific and Technical Information of China (English)

    李向宇; 柳垂亮; 潘飞鹏; 黎涌; 招伟贤

    2011-01-01

    Objective To investigate the effect of Shenfu injection on hemodynamics and systemic oxygen metabolism during off-pump coronary artery bypass grafting (OPCABG).Methods Fifty-six patients with coronary heart disease undergoing selective OPCABG (ASA Ⅱ -Ⅲ )were randomly assigned to Shenfu group (SF,n=29) and normal saline control group (NS,n=27).Patients in SF group received Shenfu 40 ml via intravenous injection prior to dermal preparation and graft anastamosis,respectively.In contrast,an equivalent volume of normal saline was injected in subjects of NS group.Hemodynamics and systemic oxygen metabolism was monitored using Swan-Ganz catheter,arterial and mixed venous blood gas analysis during anesthesia and surgery at nine time points of post anesthetic induction with stable hemodynamics (T1),after stemotomy (T2),before vascular anastomosis (T3),anterior drop branch anastomosis (T4),posterior descending artery or right coronary artery anastamosis(T5),left circumflex coronary artery or diagonal branch anastamosis (T6),cardiac at original position after vascular anastomosis (T7),before sternum closur(T8)and the end of operation(T9).Results Cardiac index (CI) and stroke index (SI) were significantly lower after posterior descending artery or right coronary artery anastamosis (T5) and left circumflex coronary artery or diagonal branch anastamosis (T6) as compared with post anesthetic induction with stable hemodynamics (T1)[(2.1 ±0.6) and (2.0 ±0.5) vs (2.3±0.5) L·min-1·m-2,(1.7 ±0.6) and (1.8 ±0.6) vs (2.1±0.5) L·min-1·m-2;(24±10) and (23 ±8) vs (32±7) ml·beat-1·m-2,(22 ±9) and (22 ±8) vs (32±9) ml·beat-1·m-2,P<0.05].As compared with NS group,CI in SF group after sternotomy (T2) or T5 was slightly higher[ (2.5 ±0.7) vs (2.1 ±0.6) L·min-1·m-2,(2.1 ±0.6) vs (1.7 ±0.6) L·min-1·m-2,P<0.05].During the operation,HR,MAP,LVWI and RVWI in SF group were slightly higher as compared with NS group (P<0.05).pH decreased with time in both groups and

  7. Protective Effects of Danhong Injection against Cerebral Damage during On-Pump Coronary Artery Bypass Graft Surgery.

    Science.gov (United States)

    Xuejuan, Zhang; Jietao, Zhang; Di, Han; Yu, Zheng; Xiaozi, Guo; Yunfa, Li; Lihua, Dong

    2015-01-01

    To explore the protective effects of Danhong injection against cerebral damage during on-pump coronary artery bypass graft surgery and its mechanism. Methods. Fifty patients scheduled for on-pump CABG surgery were randomly divided into Danhong injection group (group D) and control group (group C). Group D was given Danhong injection while group C was given the same volume of normal saline when the artery was cut open. Jugular bulb blood right before the operation began (T1), when body temperature rewarming to 36°C (T2), 30 min after the termination of cardiopulmonary bypass (T3), and 6 hrs after the termination of CPB (T4) was collected. The superoxide dismutase activity by using xanthine oxidase method and concentration determination of malondialdehyde were examined. Results. In group C, SOD activity was less at T2-T4 than at T1. It was also less active comparatively in group D at T2-T4. The MDA concentration increased in both groups but was more obvious in group C. Levels of TNF-α, IL-6, IL-8, and IL-10 increased in both groups C and D at T3 and T4, compared to T1. Conclusions. Danhong injection shows significant protective effects against cerebral damage during on-pump coronary artery bypass graft surgery.

  8. On-pump beating heart coronary surgery for high risk patients requiring emergency multiple coronary artery bypass grafting

    Directory of Open Access Journals (Sweden)

    von Segesser Ludwig K

    2008-07-01

    Full Text Available Abstract Background Cardiopulmonary bypass (CPB with aortic cross-clamping and cardioplegic arrest remains the method of choice for patients requiring standard myocardial revascularization. Therefore, very high-risk patients presenting with acute coronary syndrome, unstable angina, onset of cardiac decompensation and requiring emergency multiple myocardial revascularization, can have a poor outcome. The on-pump beating heart technique can reduce the mortality and the morbidity in such a selected group of patients and this report describes our clinical experience. Methods Out of 290 patients operated for CABG from January 2005 to January 2006, 25 (8.6% selected high-risk patients suffering from life threatening coronary syndrome (mean age 69 ± 7 years and requiring emergency multiple myocardial revascularization, underwent on-pump beating heart surgery. The mean pre-operative left ventricle ejection fraction (LVEF was 27 ± 8%. The majority of them (88% suffered of tri-vessel coronary disease and 6 (24% had a left main stump disease. Nine patients (35% were on severe cardiac failure and seven among them (28% received a pre-operative intra-aortic balloon pump. The pre-operative EuroScore rate was equal or above 8 in 18 patients (73%. Results All patients underwent on-pump-beating heart coronary revascularization. The mean number of graft/patient was 2.9 ± 0.6 and the internal mammary artery was used in 23 patients (92%. The mean CPB time was 84 ± 19 minutes. Two patients died during the recovery stay in the intensive care unit, and there were no postoperative myocardial infarctions between the survivors. Eight patients suffered of transitorily renal failure and 1 patient developed a sternal wound infection. The mean hospital stay was 12 ± 7 days. The follow-up was complete for all 23 patients survived at surgery and the mean follow-up time was 14 ± 5 months. One patient died during the follow-up for cardiac arrest and 2 patients required an

  9. On-pump beating heart coronary surgery for high risk patients requiring emergency multiple coronary artery bypass grafting.

    Science.gov (United States)

    Ferrari, Enrico; Stalder, Nicolas; von Segesser, Ludwig K

    2008-07-02

    Cardiopulmonary bypass (CPB) with aortic cross-clamping and cardioplegic arrest remains the method of choice for patients requiring standard myocardial revascularization. Therefore, very high-risk patients presenting with acute coronary syndrome, unstable angina, onset of cardiac decompensation and requiring emergency multiple myocardial revascularization, can have a poor outcome. The on-pump beating heart technique can reduce the mortality and the morbidity in such a selected group of patients and this report describes our clinical experience. Out of 290 patients operated for CABG from January 2005 to January 2006, 25 (8.6%) selected high-risk patients suffering from life threatening coronary syndrome (mean age 69 +/- 7 years) and requiring emergency multiple myocardial revascularization, underwent on-pump beating heart surgery. The mean pre-operative left ventricle ejection fraction (LVEF) was 27 +/- 8%. The majority of them (88%) suffered of tri-vessel coronary disease and 6 (24%) had a left main stump disease. Nine patients (35%) were on severe cardiac failure and seven among them (28%) received a pre-operative intra-aortic balloon pump. The pre-operative EuroScore rate was equal or above 8 in 18 patients (73%). All patients underwent on-pump-beating heart coronary revascularization. The mean number of graft/patient was 2.9 +/- 0.6 and the internal mammary artery was used in 23 patients (92%). The mean CPB time was 84 +/- 19 minutes. Two patients died during the recovery stay in the intensive care unit, and there were no postoperative myocardial infarctions between the survivors. Eight patients suffered of transitorily renal failure and 1 patient developed a sternal wound infection. The mean hospital stay was 12 +/- 7 days. The follow-up was complete for all 23 patients survived at surgery and the mean follow-up time was 14 +/- 5 months. One patient died during the follow-up for cardiac arrest and 2 patients required an implantable cardiac defibrillator. One

  10. 不同剂量右美托咪定对非体外循环冠状动脉旁路移植术中血流动力学的影响%Effects of different doses of dexmedetomidine on hemodynamics in patients undergoing off-pump coronary artery bypass grafting

    Institute of Scientific and Technical Information of China (English)

    罗伟; 孙莹杰; 刘晓宇; 于洋; 刘康; 李伟彦

    2016-01-01

    significantly(P <0.05). Conclusion In OPCABG, dexmedetomidine infused at 0.4μg/(kg· h) after a loading dose of 0.5μg/(kg· 10 min) is useful in maintaining stable hemodynamics which contributes to oxygen balance and reduces myocardium injury in patients.%目的:右美托咪定具有一定的心脏保护作用,但其对非体外循环冠状动脉旁路移植术( off-pump coronary artery bypass grafting surgery, OPCABG)患者血流动力学的影响研究较少。文中旨在观察不同剂量右美托咪定对OPCABG患者术中血流动力学的影响。方法采用随机数字表法将60例择期行 OPCABG 患者分为4组( n =15):右美托咪定0.2μg/(kg· h)组、0.4μg/(kg· h)组、0.6μg/(kg· h)组和等渗盐水组。右美托咪定0.2μg/(kg· h)组、0.4μg/(kg· h)组、0.6μg/(kg· h)组于麻醉诱导前静脉输注右美托咪定负荷剂量0.5μg/kg,持续时间10 min,随后分别以0.2、0.4、0.6μg/(kg· h)的速率维持至术毕,等渗盐水组以相同速率给予等量等渗盐水。分别于入室后( T0)、麻醉诱导前( T1)、气管插管5 min后(T2)、锯开胸骨时(T3)、吻合前降支结束(T4)、吻合右冠状动脉或左旋支结束(T5)和术毕(T6)记录各项血流动力学指标,记录术中血管活性药物总量及心脏不良事件发生率情况。结果 T3至 T6时段,右美托咪定0.4μg/(kg· h)组、0.6μg/( kg· h)组心率、平均动脉压( mean artery pressure, MAP)、中心静脉压( central venous pressure, CVP)、平均肺动脉压( mean pulmonary artery pressure, MPAP)、肺毛细血管楔压( pulmonary capillary wedge pressure, PCWP)较同时段等渗盐水组明显下降(P<0.05)。右美托咪定0.2μg/(kg· h)组、等渗盐水组的体循环阻力指数(systemic vascular resistance index,SVRI)及肺循环阻力指数(pulmonary vascular

  11. Is the randomised controlled trial the best?

    African Journals Online (AJOL)

    is taken out of the analysis, or to the exaggeration of effect; in a large study, for ... randomisation was 64 years; yet most often hormone replacement therapy (HRT) is ... in labour, and not the aggressive syntocinon augmentation, in the highly ...

  12. Increasing recruitment to randomised trials: a review of randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Torgerson David J

    2006-07-01

    Full Text Available Abstract Background Poor recruitment to randomised controlled trials (RCTs is a widespread and important problem. With poor recruitment being such an important issue with respect to the conduct of randomised trials, a systematic review of controlled trials on recruitment methods was undertaken in order to identify strategies that are effective. Methods We searched the register of trials in Cochrane library from 1996 to end of 2004. We also searched Web of Science for 2004. Additional trials were identified from personal knowledge. Included studies had to use random allocation and participants had to be allocated to different methods of recruitment to a 'real' randomised trial. Trials that randomised participants to 'mock' trials and trials of recruitment to non-randomised studies (e.g., case control studies were excluded. Information on the study design, intervention and control, and number of patients recruited was extracted by the 2 authors. Results We identified 14 papers describing 20 different interventions. Effective interventions included: telephone reminders; questionnaire inclusion; monetary incentives; using an 'open' rather than placebo design; and making trial materials culturally sensitive. Conclusion Few trials have been undertaken to test interventions to improve trial recruitment. There is an urgent need for more RCTs of recruitment strategies.

  13. Randomised controlled trials: important but overrated?

    LENUS (Irish Health Repository)

    Boylan, J F

    2012-02-01

    Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial (RCT) is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons. Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered? In this controversy we explore the interpretation of RCT data for practising clinicians facing individualised patient choices. First, critical care anaesthetists John Boylan and Brian Kavanagh emphasise the dangers of bias and show how Bayesian approaches utilise prior probabilities to improve posterior (combined) probability estimates. Secondly, Jane Armitage, of the Clinical Trial Service Unit in Oxford, argues why RCTs remain essential and explores how the quality of randomisation can be improved through systematic reviews and by avoiding selective reporting.

  14. Razors versus clippers. A randomised controlled trial.

    Science.gov (United States)

    Taylor, Tracy; Tanner, Judith

    2005-12-01

    The purpose of this randomised controlled trial was to determine if patients showed a preference for preoperative hair removal with razors or clippers and to identify if one method was associated with more trauma or postoperative infections. The trial took place in a day surgery unit with patients who were having a range of surgical procedures including hernias and varicose veins. This study was sponsored by an award from the NATN/3M Clinical Fellowship.

  15. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2012-01-01

    To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes.......To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes....

  16. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2012-01-01

    To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes.......To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes....

  17. [Mendelian randomisation - a genetic approach to an epidemiological method].

    Science.gov (United States)

    Stensrud, Mats Julius

    2016-06-01

    BACKGROUND Genetic information is becoming more easily available, and rapid progress is being made in developing methods of illuminating issues of interest. Mendelian randomisation makes it possible to study causes of disease using observational data. The name refers to the random distribution of gene variants in meiosis. The methodology makes use of genes that influence a risk factor for a disease, without influencing the disease itself. In this review article I explain the principles behind Mendelian randomisation and present the areas of application for this methodology.MATERIAL AND METHOD Methodology articles describing Mendelian randomisation were reviewed. The articles were found through a search in PubMed with the combination «mendelian randomization» OR «mendelian randomisation», and a search in McMaster Plus with the combination «mendelian randomization». A total of 15 methodology articles were read in full text. Methodology articles were supplemented by clinical studies found in the PubMed search.RESULTS In contrast to traditional observational studies, Mendelian randomisation studies are not affected by two important sources of error: conventional confounding variables and reverse causation. Mendelian randomisation is therefore a promising tool for studying causality. Mendelian randomisation studies have already provided valuable knowledge on the risk factors for a wide range of diseases. It is nevertheless important to be aware of the limitations of the methodology. As a result of the rapid developments in genetics research, Mendelian randomisation will probably be widely used in future years.INTERPRETATION If Mendelian randomisation studies are conducted correctly, they may help to reveal both modifiable and non-modifiable causes of disease.

  18. Wound healing with honey - a randomised controlled trial

    African Journals Online (AJOL)

    Gold Mining and Westonaria Gold Mining from September. 1995 to July 1996 ... glycol20%, starch copolymer 2% and water 78%. ... Table I. Wound types randomised by block for treatment with honey or IntraSite Gel (withdrawn from analysis)*.

  19. Group sequential designs for stepped-wedge cluster randomised trials.

    Science.gov (United States)

    Grayling, Michael J; Wason, James Ms; Mander, Adrian P

    2017-06-01

    The stepped-wedge cluster randomised trial design has received substantial attention in recent years. Although various extensions to the original design have been proposed, no guidance is available on the design of stepped-wedge cluster randomised trials with interim analyses. In an individually randomised trial setting, group sequential methods can provide notable efficiency gains and ethical benefits. We address this by discussing how established group sequential methodology can be adapted for stepped-wedge designs. Utilising the error spending approach to group sequential trial design, we detail the assumptions required for the determination of stepped-wedge cluster randomised trials with interim analyses. We consider early stopping for efficacy, futility, or efficacy and futility. We describe first how this can be done for any specified linear mixed model for data analysis. We then focus on one particular commonly utilised model and, using a recently completed stepped-wedge cluster randomised trial, compare the performance of several designs with interim analyses to the classical stepped-wedge design. Finally, the performance of a quantile substitution procedure for dealing with the case of unknown variance is explored. We demonstrate that the incorporation of early stopping in stepped-wedge cluster randomised trial designs could reduce the expected sample size under the null and alternative hypotheses by up to 31% and 22%, respectively, with no cost to the trial's type-I and type-II error rates. The use of restricted error maximum likelihood estimation was found to be more important than quantile substitution for controlling the type-I error rate. The addition of interim analyses into stepped-wedge cluster randomised trials could help guard against time-consuming trials conducted on poor performing treatments and also help expedite the implementation of efficacious treatments. In future, trialists should consider incorporating early stopping of some kind into

  20. The Hawthorne Effect: a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    van Haselen Robbert

    2007-07-01

    Full Text Available Abstract Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months. Our primary outcomes were cognitive functioning (ADAS-Cog and participant and carer-rated quality of life (QOL-AD. Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT, with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group, and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group. There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048

  1. Lessons from randomised direct comparative trials.

    Science.gov (United States)

    Achiron, Anat; Fredrikson, Sten

    2009-02-01

    For over a decade, four immunomodulatory therapies have been available for the treatment of relapsing remitting multiple sclerosis. However, few direct comparative data were available to facilitate the choice of treatment. This choice has been influenced by the perception that interferon-beta preparations have greater efficacy than glatiramer acetate, due to apparently more rapid and robust reduction of gadolinium-enhancing lesions seen on magnetic resonance imaging in the pivotal trials of these agents. This situation has changed in the last year, with the outcomes of three randomised clinical trials comparing the efficacy and safety of glatiramer acetate with that of a high-dose interferon-beta in relapsing remitting multiple sclerosis. These are the REGARD, BEYOND and BECOME trials. In the REGARD trial, 764 patients were randomised to treatment with either interferon-beta 1a sc 44 microg or glatiramer acetate for 96 weeks; no significant difference in the time to first relapse was observed. The largest of the three comparative studies, the BEYOND trial, compared treatment with interferon-beta 1b sc 500 microg, interferon-beta 1b sc 250 microg or glatiramer acetate for two years in 2,244 patients. The hazard ratio for multiple relapses was close to unity for comparisons between all groups, indicating equivalent efficacy in all three treatment arms. Relapse rates (around 0.3 relapses/year) in all these studies were much lower than anticipated and lower than those reported a decade previously in the pivotal trials of beta-interferons and glatiramer acetate. No unexpected safety issues were identified in any of these studies. The completion of these direct comparative studies has considerably enriched the clinical evidence database by contributing large numbers of patients. This provides an invaluable contribution for helping the physician make an informed choice about treatment. The results of the direct comparative studies provide evidence that glatiramer acetate

  2. Alterations in antioxidant and oxidant status of children after on-pump surgery for cyanotic and acyanotic congenital heart diseases.

    Science.gov (United States)

    Altin, Firat H; Yildirim, Hayriye A; Tanidir, Ibrahim C; Yildiz, Okan; Kahraman, Meliha Z; Ozturk, Erkut; Celebi, Sinem B; Kyaruzi, Mugisha; Bakir, İhsan

    2017-03-01

    Oxidative stress refers to an imbalance between reactive oxidative species and antioxidants. In this case-controlled, prospective, observational study, we investigated the total oxidant status, total antioxidant status, oxidative stress index, and albumin and C-reactive protein levels of children with cyanotic and acyanotic congenital heart diseases who had undergone on-pump cardiac surgery. The study groups consisted of 60 patients with congenital heart disease, who were operated under cardiopulmonary bypass, and a control group of 30 healthy individuals. The patients were classified into two groups. Among them, one was a patient group that consisted of 30 patients with acyanotic congenital heart disease and the other group consisted of 30 patients with cyanotic congenital heart disease. In the patient groups, blood samples were collected before surgery and at one and 24 hours following surgery. In control groups, blood samples were collected once during hospital admission. No statistically significant differences were found between the groups in terms of baseline total oxidant status, total antioxidant status, and oxidative stress index values. Regarding the postoperative first-hour and 24-hour total oxidant status and total antioxidant status levels as well as oxidative stress index values, there were no significant differences between the groups, except for an increase in total antioxidant status levels (p=0.002) 24 hours after surgery in cyanotic patients. There was no difference between oxidative stress status of cyanotic and acyanotic congenital heart disease patients and healthy individuals. Oxidative stress status of cyanotic and acyanotic patients does not change after cardiac surgery under cardiopulmonary bypass.

  3. Mendelian randomisation in cardiovascular research: an introduction for clinicians.

    Science.gov (United States)

    Bennett, Derrick A; Holmes, Michael V

    2017-09-01

    Understanding the causal role of biomarkers in cardiovascular and other diseases is crucial in order to find effective approaches (including pharmacological therapies) for disease treatment and prevention. Classical observational studies provide naïve estimates of the likely role of biomarkers in disease development; however, such studies are prone to bias. This has direct relevance for drug development as if drug targets track to non-causal biomarkers, this can lead to expensive failure of these drugs in phase III randomised controlled trials. In an effort to provide a more reliable indication of the likely causal role of a biomarker in the development of disease, Mendelian randomisation studies are increasingly used, and this is facilitated by the availability of large-scale genetic data. We conducted a narrative review in order to provide a description of the utility of Mendelian randomisation for clinicians engaged in cardiovascular research. We describe the rationale and provide a basic description of the methods and potential limitations of Mendelian randomisation. We give examples from the literature where Mendelian randomisation has provided pivotal information for drug discovery including predicting efficacy, informing on target-mediated adverse effects and providing potential new evidence for drug repurposing. The variety of the examples presented illustrates the importance of Mendelian randomisation in order to prioritise drug targets for cardiovascular research. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  4. Off-pump atrial septostomy with thoracoscopic scissors under transesophageal echocardiography guidance

    Directory of Open Access Journals (Sweden)

    Raj R Benedict

    2013-01-01

    Full Text Available Selected children with congenital heart defects undergoing palliative closed heart procedures require a cardiopulmonary bypass (CPB run only for the purpose of creating an inter-atrial communication. We report a simple technique of atrial septostomy using thoracoscopy scissors under transesophageal echocardiography guidance without the need for CPB.

  5. Off-pump replacement of the INCOR implantable axial-flow pump.

    Science.gov (United States)

    Nakashima, Kuniki; Kirsch, Matthias E W; Vermes, Emmanuelle; Rosanval, Odile; Loisance, Daniel

    2009-02-01

    Owing to the actual increase of mechanical circulatory support durations, total or partial replacement of ventricular assist devices (VADs) will most certainly have to be performed with increasing frequency. Herein we report the case of a patient in whom an INCOR (Berlin Heart AG, Berlin) implantable axial-flow pump was replaced without the use of cardiopulmonary bypass (CPB), underscoring some of the unique features provided by this system.

  6. Anesthetic considerations for the patients with off-pump coronary artery bypass grafting

    Institute of Scientific and Technical Information of China (English)

    2005-01-01

    New surgical techniques for coronary artery bypass graft (CABG) have been explored in order to minimize disfiguring scars, avoid cardiopulmonary bypass and decrease hospital residence and costs etc. Improved surgical expertise can perform the procedures in some high-risk patients such as poor left ventricular function, redo CABG, advanced age and renal dysfunction etc. Intraoperatively there is an obligatory period of myocardial ischemia, which may lead to significant hemodynamic consequences. It is a quite challenge to anesthetist in managing the intraoperative patient.

  7. Applying the intention-to-treat principle in practice: Guidance on handling randomisation errors.

    Science.gov (United States)

    Yelland, Lisa N; Sullivan, Thomas R; Voysey, Merryn; Lee, Katherine J; Cook, Jonathan A; Forbes, Andrew B

    2015-08-01

    The intention-to-treat principle states that all randomised participants should be analysed in their randomised group. The implications of this principle are widely discussed in relation to the analysis, but have received limited attention in the context of handling errors that occur during the randomisation process. The aims of this article are to (1) demonstrate the potential pitfalls of attempting to correct randomisation errors and (2) provide guidance on handling common randomisation errors when they are discovered that maintains the goals of the intention-to-treat principle. The potential pitfalls of attempting to correct randomisation errors are demonstrated and guidance on handling common errors is provided, using examples from our own experiences. We illustrate the problems that can occur when attempts are made to correct randomisation errors and argue that documenting, rather than correcting these errors, is most consistent with the intention-to-treat principle. When a participant is randomised using incorrect baseline information, we recommend accepting the randomisation but recording the correct baseline data. If ineligible participants are inadvertently randomised, we advocate keeping them in the trial and collecting all relevant data but seeking clinical input to determine their appropriate course of management, unless they can be excluded in an objective and unbiased manner. When multiple randomisations are performed in error for the same participant, we suggest retaining the initial randomisation and either disregarding the second randomisation if only one set of data will be obtained for the participant, or retaining the second randomisation otherwise. When participants are issued the incorrect treatment at the time of randomisation, we propose documenting the treatment received and seeking clinical input regarding the ongoing treatment of the participant. Randomisation errors are almost inevitable and should be reported in trial publications. The

  8. EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment.

    Science.gov (United States)

    Whelan, J S; Bielack, S S; Marina, N; Smeland, S; Jovic, G; Hook, J M; Krailo, M; Anninga, J; Butterfass-Bahloul, T; Böhling, T; Calaminus, G; Capra, M; Deffenbaugh, C; Dhooge, C; Eriksson, M; Flanagan, A M; Gelderblom, H; Goorin, A; Gorlick, R; Gosheger, G; Grimer, R J; Hall, K S; Helmke, K; Hogendoorn, P C W; Jundt, G; Kager, L; Kuehne, T; Lau, C C; Letson, G D; Meyer, J; Meyers, P A; Morris, C; Mottl, H; Nadel, H; Nagarajan, R; Randall, R L; Schomberg, P; Schwarz, R; Teot, L A; Sydes, M R; Bernstein, M

    2015-02-01

    Four international study groups undertook a large study in resectable osteosarcoma, which included two randomised controlled trials, to determine the effect on survival of changing post-operative chemotherapy based on histological response. Patients with resectable osteosarcoma aged ≤40 years were treated with the MAP regimen, comprising pre-operatively of two 5-week cycles of cisplatin 120 mg/m(2), doxorubicin 75 mg/m(2), methotrexate 12 g/m(2) × 2 (MAP) and post-operatively two further cycles of MAP and two cycles of just MA. Patients were randomised after surgery. Those with ≥10% viable tumour in the resected specimen received MAP or MAP with ifosfamide and etoposide. Those with osteosarcoma study to date in 75 months. Commencing March 2005, 2260 patients were registered from 326 centres across 17 countries. About 1334 of 2260 registered patients (59%) were randomised. Pre-operative chemotherapy was completed according to protocol in 94%. Grade 3-4 neutropenia affected 83% of cycles and 59% were complicated by infection. There were three (0.13%) deaths related to pre-operative chemotherapy. At definitive surgery, 50% of patients had at least 90% necrosis in the resected specimen. New models of collaboration are required to successfully conduct trials to improve outcomes of patients with rare cancers; EURAMOS-1 demonstrates achievability. Considerable regulatory, financial and operational challenges must be overcome to develop similar studies in the future. The trial is registered as NCT00134030 and ISRCTN 67613327. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

  9. Experience of valve replacement under mild hypothermia on pump-beating heart:an analysis of 800 cases

    Institute of Scientific and Technical Information of China (English)

    陈柏成; 肖颖彬; 陈林; 钟前进; 王学锋; 周骐; 易广兵

    2004-01-01

    Objective: To assess the outcome of valve replacement under mild hypothermia on pump-beating heart and to discuss the risk factors of cardiac valve surgery. Methods: In the period from November 1997 to May 2003, a total of 800cases of valve replacement were carried out in our institute. The clinical data were reviewed and the technique of mild hypothermia and pump-beating heart to replace cardiac valve was described in detail. Results: 800 patients, 308 male and 492female, with age range from 8 to 66 years, weighing 19 to 88 kg, underwent operation. The average cardiopulmonary bypass time was (109.38 ± 40.64) min, the average clamping time of the vena cava was (77.87 ± 27.99) min and the average mechanical ventilation time was (17.78 ± 12.21) h. There were 17 patients died in the early postoperative stage with an early mortality rate of 2.13%. The causes of death were failure in the weaning of extracorporeal circulation in 2 cases, severe low output syndrome in 3 cases, ventricular fibrillation in 3 cases, obstruction of coronary ostium of mechanical prosthetic valve in 1 case, hepatic failure in 2 cases, pulmonary failure in 1 case, multiorgan failure in 4 cases, and prosthetic valve dysfunction in 1 case. Severe postopertive complications occurred in 51 cases (6.375%), which included reexploration because of excessive bleeding in 16 cases (2.0%), lavage of poststemal infection in 2 cases (0.25%), postoperative strike in 7 cases (0.875%), pulmonary failure in 5 cases (0.625%), hepatic failure in 4 cases (0.5%), multiorgan failure in 11 cases (1.375 % ), ventricular arrhythmia in 5 cases (0.625%) and peripheral circulation failure in 1 case(0. 125 % ). Conclusion: Mild hypothermia and pump-beating heart result in satisfying clinical outcome in patients undergoing valve replacement. The integrated sequenced deairing procedure ensures the avoidance of air embolism during operation.Pump-beating heart technique offers a safe and practical option especially in

  10. Promoting public awareness of randomised clinical trials using the media: the 'Get Randomised' campaign.

    Science.gov (United States)

    Mackenzie, Isla S; Wei, Li; Rutherford, Daniel; Findlay, Evelyn A; Saywood, Wendy; Campbell, Marion K; Macdonald, Thomas M

    2010-02-01

    WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT * Recruitment is key to the success of clinical trials. * Many clinical trials fail to achieve adequate recruitment. * Public understanding and engagement in clinical research could be improved. WHAT THIS STUDY ADDS * 'Get Randomised' is the first campaign of its kind in the UK. * It is possible to improve public awareness of clinical research using the media. * Further work is needed to determine whether improved public awareness leads to increased participation in clinical research in the future. AIM To increase public awareness and understanding of clinical research in Scotland. METHODS A generic media campaign to raise public awareness of clinical research was launched in 2008. The 'Get Randomised' campaign was a Scotland-wide initiative led by the University of Dundee in collaboration with other Scottish universities. Television, radio and newspaper advertising showed leading clinical researchers, general practitioners and patients informing the public about the importance of randomised clinical trials (RCTs). 'Get Randomised' was the central message and interested individuals were directed to the http://www.getrandomised.org website for more information. To assess the impact of the campaign, cross-sectional surveys were conducted in representative samples of 1040 adults in Scotland prior to campaign launch and again 6 months later. RESULTS There was an improvement in public awareness of clinical trials following the campaign; 56.7% [95% confidence interval (CI) 51.8, 61.6] of the sample recalled seeing or hearing advertising about RCTs following the campaign compared with 14.8% (10.8, 18.9) prior to the campaign launch (difference = 41.4%; 95% CI for difference 35.6, 48.3; P advertising, 49% felt that the main message was that people should take part more in medical research. However, on whether they would personally take part in a clinical trial if asked, there was little difference in response following the campaign

  11. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials

    DEFF Research Database (Denmark)

    Savović, J; Jones, He; Altman, Dg

    2012-01-01

    The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...

  12. Structured risk assessment and violence in acute psychiatric wards: randomised controlled trial

    National Research Council Canada - National Science Library

    Abderhalden, Christoph; Needham, Ian; Dassen, Theo; Halfens, Ruud; Haug, Hans-Joachim; Fischer, Joachim E

    2008-01-01

    .... To assess whether such risk assessments decrease the incidence of violence and coercion. A cluster randomised controlled trial was conducted with 14 acute psychiatric admission wards as the units of randomisation, including a preference arm...

  13. A randomised comparison of cognitive behavioural therapy

    Directory of Open Access Journals (Sweden)

    Carlijn de Roos

    2011-04-01

    Full Text Available Background : Building on previous research with disaster-exposed children and adolescents, a randomised clinical trial was performed in the treatment of trauma-related symptoms. In the current study two active treatments were compared among children in a broad age range and from a wide diversity of ethnic populations. Objective : The primary aim was to compare the effectiveness and efficiency of Cognitive Behavioural Therapy (CBT and Eye Movement Desensitisation and Reprocessing (EMDR. Design : Children (n=52, aged 4–18 were randomly allocated to either CBT (n=26 or EMDR (n=26 in a disaster mental health after-care setting after an explosion of a fireworks factory. All children received up to four individual treatment sessions over a 4–8 week period along with up to four sessions of parent guidance. Blind assessment took place pre- and post-treatment and at 3 months follow-up on a variety of parent-rated and self-report measures of post-traumatic stress disorder symptomatology, depression, anxiety, and behaviour problems. Analyses of variance (general linear model repeated measures were conducted on the intention-to-treat sample and the completers. Results : Both treatment approaches produced significant reductions on all measures and results were maintained at follow-up. Treatment gains of EMDR were reached in fewer sessions. Conclusion : Standardised CBT and EMDR interventions can significantly improve functioning of disaster-exposed children.For the abstract in other languages, please see Supplementary files under Reading Tools online

  14. Genetic Polymorphisms in Endothelin-1 as Predictors for Long-Term Survival and the Cardiac Index in Patients Undergoing On-Pump Cardiac Surgery.

    Directory of Open Access Journals (Sweden)

    Ashham Mansur

    Full Text Available Genetic variants within the endothelin-1 gene (EDN1 have been associated with several cardiovascular diseases and may act as genetic prognostic markers. Here, we explored the overall relevance of EDN1 polymorphisms for long-term survival in patients undergoing on-pump cardiac surgery. A prospectively collected cohort of 455 Caucasian patients who underwent cardiac surgery with cardiopulmonary bypass was followed up for 5 years. The obtained genotypes and inferred haplotypes were analyzed for their associations with the five-year mortality rate (primary endpoint. The EDN1 T-1370G and K198N genotype distributions did not deviate from Hardy-Weinberg equilibrium and the major allele frequencies were 83% and 77%, respectively. The cardiovascular risk factors were equally distributed in terms of the different genotypes and haplotypes associated with the two polymorphisms. The five-year mortality rate did not differ among the different EDN1 T-1370G and K198N genotypes and haplotypes. Haplotype analysis revealed that carriers of the G-T (compound EDN1 T-1370G G/K198N T haplotype had a higher cardiac index than did non-carriers (p = 0.0008; however, this difference did not reach significance after adjusting for multiple testing. The results indicate that common variations in EDN1 do not act as prognostic markers for long-term survival in patients undergoing on-pump cardiac surgery.

  15. Radiotherapy for Graves' orbitopathy : randomised placebo-controlled study

    NARCIS (Netherlands)

    Mourits, MP; van Kempen-Harteveld, ML; Garcia, MBG; Koppeschaar, HPF; Tick, L; Terwee, CB

    2000-01-01

    Background The best treatment (steroids, irradiation, or both) for moderately severe Graves' orbitopathy, a self-limiting disease is not known. We tested the efficacy of external beam irradiation compared with sham-irradiation. Methods In a double-blind randomised clinical trial, 30 patients with

  16. Authenticity of instruction and student performance: a prospective randomised trial.

    NARCIS (Netherlands)

    Rochelle, J.S. La; Durning, S.J.; Pangaro, L.N.; Artino, A.R.; Vleuten, C.P.M. van der; Schuwirth, L.

    2011-01-01

    OBJECTIVES: This study aimed to investigate the relationship between the authenticity of instructional formats and outcome measures within a pre-clerkship clinical reasoning course. METHODS: We conducted a randomised, prospective, crossover study with Year 2 medical students taking a pre-clerkship c

  17. The SafeBoosC Phase II Randomised Clinical Trial

    DEFF Research Database (Denmark)

    Pellicer, Adelina; Greisen, Gorm; Benders, Manon

    2013-01-01

    Near-infrared spectroscopy-derived regional tissue oxygen saturation of haemoglobin (rStO2) reflects venous oxygen saturation. If cerebral metabolism is stable, rStO2 can be used as an estimate of cerebral oxygen delivery. The SafeBoosC phase II randomised clinical trial hypothesises that the bur...

  18. Radiotherapy for Graves' orbitopathy : randomised placebo-controlled study

    NARCIS (Netherlands)

    Mourits, MP; van Kempen-Harteveld, ML; Garcia, MBG; Koppeschaar, HPF; Tick, L; Terwee, CB

    2000-01-01

    Background The best treatment (steroids, irradiation, or both) for moderately severe Graves' orbitopathy, a self-limiting disease is not known. We tested the efficacy of external beam irradiation compared with sham-irradiation. Methods In a double-blind randomised clinical trial, 30 patients with mo

  19. Yoga in schizophrenia : a systematic review of randomised controlled trials

    NARCIS (Netherlands)

    Vancampfort, D.; Vansteelandt, K.; Scheewe, T.; Probst, M.; Knapen, J.; De Herdt, A.; De Hert, M.

    2012-01-01

    Vancampfort D, Vansteelandt K, Scheewe T, Probst M, Knapen J, De Herdt A, De Hert M. Yoga in schizophrenia: a systematic review of randomised controlled trials. Objective: The objective of this systematic review was to assess the effectiveness of yoga as a complementary treatment on general psychopa

  20. Yoga in schizophrenia : a systematic review of randomised controlled trials

    NARCIS (Netherlands)

    Vancampfort, D.; Vansteelandt, K.; Scheewe, T.; Probst, M.; Knapen, J.; De Herdt, A.; De Hert, M.

    2012-01-01

    Vancampfort D, Vansteelandt K, Scheewe T, Probst M, Knapen J, De Herdt A, De Hert M. Yoga in schizophrenia: a systematic review of randomised controlled trials. Objective: The objective of this systematic review was to assess the effectiveness of yoga as a complementary treatment on general psychopa

  1. A prospective, randomised, controlled clinical trial to evaluate the ...

    African Journals Online (AJOL)

    ... reactivity to carbon dioxide and autoregulation.1,2 ... Capnography [end-tidal carbon dioxide (EtCO2)]. ... The patients were randomised into two groups using a random ... 67% N2O in oxygen in group A, and 33% oxygen in air in group B,.

  2. The effect of orthodontic referral guidelines: A randomised controlled trial

    OpenAIRE

    Conboy, Frances; O'Brien, K.

    2000-01-01

    Objective To develop and evaluate the effectiveness of referral guidelines for the referral of orthodontic patients to consultant and specialist practijioner orthodontists. Design Single centre randomised controlled trial with random allocation of referral guidelines for orthodontic treatment to general dental practitioners. Setting Hospital orthodontic departments and specialist orthodontic practices in Manchester and Stockport. Subjects General dental practitioners and the patients they ref...

  3. Effects of patient safety culture interventions on incident reporting in general practice : A cluster randomised trial a cluster randomised trial

    NARCIS (Netherlands)

    Verbakel, Natasha J.; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

    2015-01-01

    Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial

  4. Comparison of plasma NSE, protein S-100b and EEG changes in traditional arrested-heart procedures and on-pump beating-heart procedures

    Institute of Scientific and Technical Information of China (English)

    王咏; 肖颖彬; 陈林; 王学锋; 钟前进

    2003-01-01

    Objective: To assess the cerebral injury in on-pump beating-heart procedures under mild hypothermia in comparison with traditional on-pump arrested-heart procedures under moderate hypothermia. Methods: Forty patients, 20 with congenital heart disease (CHD) and 20 of rheumatic heart disease (RHD), were divided into 2 groups: Control group (group A, n=20) including 10 patients suffering from CHD as group A1 and the left 10 from RHD as group A2; and experiment group (group B, n=20) which consisting of group B1 (10 with CHD) and group B2 (10 of RHD). The patients in group A underwent traditional arrested-heart procedures, and those in group B were operated on with beating-heart procedures. Arterial blood samples were collected at preoperation (time A), 20 min after cardiopulmonary bypass (CPB) starting (time B), 1 h after CPB (time C) and 24 h postoperation (time D) respectively. Plasma contents of neuron-specific enolase (NSE) and protein S-100b were measured with sensitive ELISA. All the patients received echoencephalography (EEG) before and 1 week after operation. Results: The plasma contents of protein S-100b were increased very significantly at time B, C and D in comparison with those at time A (P<0.01), and that of patients in group A1 was significantly higher than that in group B at time B (P<0.05). There was no significant difference at other time points. At time B, the plasma contents of NSE were significantly higher in group A than in group B, and in group A1 and B1 than in group A2 and B2. What's more, at time B, the former fell back to their preoperative levels, but the latter remained still higher levels than the preoperative ones (P<0.01). No significant difference was found in the abnormality rates of postoperative EEG between 2 groups. Conclusion: The perioperative plasma contents of NSE and protein S-100b are not significantly higher in group B than in group A. On-pump beating-heart procedures do not make more serious cerebral dysfunction than the

  5. Subxyphoid pleural drain confers lesser impairment in respiratory muscle strength, oxygenation and lower chest pain after off-pump coronary artery bypass grafting: a randomized controlled trial Dreno pleural subxifoide confere menor comprometimento da força muscular respiratória, oxigenação e menor dor torácica após cirurgia de revascularização do miocárdio sem circulação extracorpórea: estudo controlado randomizado

    Directory of Open Access Journals (Sweden)

    Andreia S. A. Cancio

    2012-03-01

    Full Text Available OBJECTIVE: To evaluate respiratory muscle strength, oxygenation and chest pain in patients undergoing off-pump coronary artery bypass (OPCAB using internal thoracic artery grafts comparing pleural drain insertion site at the subxyphoid region versus the lateral region. METHODS: Forty patients were randomized into two groups in accordance with the pleural drain site. Group II (n = 19 -pleural drain exteriorized in the intercostal space; group (SI (n = 21 chest tube exteriorized at the subxyphoid region. All patients underwent assessment of respiratory muscle strength (inspiratory and expiratory on the pre, 1, 3 and 5 postoperative days (POD. Arterial blood gas analysis was collected on the pre and POD1. The chest pain sensation was measured 1, 3 and 5 POD. RESULTS: A significant decrease in respiratory muscle strength (inspiratory and expiratory was seen in both groups until POD5 (P OBJETIVO: Avaliar a força muscular respiratória, oxigenação e dor torácica em pacientes submetidos à cirurgia de revascularização miocárdica (RM sem circulação extracorpórea (CEC comparando o local de inserção do dreno pleural na região subxifoidea versus lateral. MÉTODOS: Quarenta pacientes foram randomizados em dois grupos Grupo (II - n = 19 - dreno pleural exteriorizado na região intercostal; Grupo (SI - n = 21 dreno pleural exteriorizado na região subxifoidea. Os pacientes foram submetidos à avaliação da força muscular respiratória no pré, 1º, 3ºe 5º dias de pós-operatório (PO. Gasometria arterial foi coletada no pré e 1º dia do PO. A dor torácica foi avaliada no 1º, 3º e 5º dias de PO. RESULTADOS: Ambos os grupos apresentaram diminuição significante da força muscular respiratória até o quinto dia do PO (P <0,05. A diferença entre os grupos manteve-se significante com maior decréscimo no grupo II (P <0,05. Houve queda na pressão arterial de oxigênio em ambos os grupos (P <0,05, mas quando comparado à queda foi maior no

  6. 采用斑点追踪食道超声观察经冠状动脉灌注舒芬太尼对2型糖尿病患者非体外循环冠脉旁路移植术后早期左心室功能失调的影响%Effect on the left ventricular dysfunction in the early postoperative period following off-pump coronary artery bypass grafting of type 2 diabetes mellitus underlying sufentanil coronary perfusion against ischemia-reperfusion injury by speckle tracking transesophageal echocardiography

    Institute of Scientific and Technical Information of China (English)

    鲁显福; 刘训芹; 顾尔伟

    2012-01-01

    背景 采用经斑点追踪食道超声(speckle tracking transesophageal echocardiography,STTE)记录左心室长轴平均收缩峰值应变(averaged global longitudinal peak systolic strain,aGLPS)值、观察舒芬太尼后处理对2型糖尿病-心血管病共病患者与单纯心血管病患者行非体外循环冠脉旁路移植(off-pump coronary artery bypass grafting,OPCABG)术后早期左心室功能失调的影响.方法 择期单纯心血管病患者(CVD组)与2型糖尿病-心血管疾病共病患者(T2DM-CVD组)各20例,择期施行OPCABG手术,术中经冠脉内灌注舒芬太尼(0.2 μg/kg)行缺血心肌后处理(Suf-PostC);经二维食道超声采集STTE/aGLPS,采用FloTrac/Vigileo及Philips M6多功能监测仪行心率(HR)、平均动脉压(MAP)、中心静脉压(CVP)、心脏指数(CI)、每搏量(SV)、左心室射血分数(LVEF).观察并测算给药后各时间点aGLPS(T0,Suf-PoC0 min;T1,Suf-PoC30 min;T2,Suf-PoC2 h;T3,SufPoC4 h;T4,Suf-PoC6 h).结果 两组患者术前除血糖外一般情况均无统计学差异;但在Suf-PoC2 h以后(冠脉全部复通后,T2-T4期),两组患者LVEF值均较术前明显改善(P<0.05);T2DM-CVD组[aGLPST0:(-13.4±2.2)%,aGLPST1:(-17.0±2.4)%,aGLPST2:( -17.3±3.1)%,aGLPST3:(-14.6±2.6)%,aGLPST4:( -14.7±1.7)%],CVD组[aGLPST0:(-13.1±2.4)%,aGLPST1:(-16.4±3.1)%,aGLPST2:( -19.6±3.4)%,aGLPST3:( -20.3±2.6)%,aGLPST4:(-20.4±1.9)%],两组患者aGLPS值在(T2~T4)期行同一时间点下的各组绝对数值比较差异有统计学意义(P<0.05). 结论 采用STTE记录aGLPS能够定量监测OPCABG患者术中左心室收缩功能;2型糖尿病削弱舒芬太尼后处理对于心肌缺血/再灌注损伤所起保护效应的临床研究仍需进一步积累资料.%Objective To assess sufentanil postconditioning against ischemia-reperfusion injury whether left ventricular systolic deformation in the early postoperative period could be estimated by speckle tracking transesophageal

  7. Probiotics in the prevention of eczema: a randomised controlled trial

    OpenAIRE

    Allen, Stephen J; Jordan, Sue; Storey, Melanie; Catherine A Thornton; Gravenor, Michael B.; Garaiova, Iveta; Plummer, Susan F; Wang, Duolao; Morgan, Gareth

    2014-01-01

    Objective To evaluate a multistrain, high-dose probiotic in the prevention of eczema. Design A randomised, double-blind, placebo-controlled, parallel group trial. Settings Antenatal clinics, research clinic, children at home. Patients Pregnant women and their infants. Interventions Women from 36 weeks gestation and their infants to age 6 months received daily either the probiotic (Lactobacillus salivarius CUL61, Lactobacillus paracasei CUL08, Bifidobacterium animalis subspecies lactis CUL34 a...

  8. A randomised controlled trial of complete denture impression materials.

    Science.gov (United States)

    Hyde, T P; Craddock, H L; Gray, J C; Pavitt, S H; Hulme, C; Godfrey, M; Fernandez, C; Navarro-Coy, N; Dillon, S; Wright, J; Brown, S; Dukanovic, G; Brunton, P A

    2014-08-01

    There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7-67.3%, pUnilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  9. Use of Lactated Ringer’s solution does not eliminate the risk of strong ion difference-related metabolic acidosis following on-pump cardiac surgery.

    Science.gov (United States)

    Jovaisa, T; Vicka, V; Linkaitė, G; Guseinovaitė, J; Ringaitienė, D; Norkienė, I

    2016-01-01

    There is a growing interest in the effects of plasma sodium levels on postoperative outcomes. A trend of using balanced crystalloid solutions is based on the extensive data on chloride and the strong ion difference-related acidosis. However, effects of sodium are often overlooked in this context. The aim of the study was to establish the effects of the routine use of Lactated Ringer’s Solution (RL) on postoperative changes in sodium concentrations and whether these changes result in metabolic acidosis. We performed database analysis of 358 consecutive elective on-pump cardiac surgery cases in a tertiary referral university hospital. Approval from the institutional ethics committee was obtained for this study. Intraoperative fluid balance was 2726±1073 ml and the total volume of intravenous infusions in the first 24 hours was 5865 (±1073) ml, 95% of which was RL; 58% of the patients had metabolic acidosis with a base excess below (–)2 mmol L–1 on arrival at the intensive care unit. There was a significant correlation between a strong ion difference and base excess (p less than 0.01). A significant improvement in metabolic acidosis was noted within the first 24 hours, from a base excess of (–)2.49±2.8 to 0.32±2.6 mmol L–1 (p less than 0.001). All of the improvement in the base excess is explained by a change in the strong ion difference from the mean value of 31±4.3 to 34.2±3.6 mmol L–1 (p less than 0.001). Changes in the strong ion difference were primarily driven by changes in the serum sodium concentration, which were three-fold higher compared to those of chloride [–2.36 (±2.6) mmol L–1 (p less than 0.001) and 0.84 (±3.2) mmol L–1, respectively (p = 0.01)]. In conclusion, our data confirm that there is a direct correlation between a strong ion difference and base excess following on-pump cardiac surgery. The use of RL prevented significant hyperchloraemia, but did not eliminate the risk of strong ion difference-related metabolic acidosis. The

  10. Applicability and generalisability of published results of randomised controlled trials and non-randomised studies evaluating four orthopaedic procedures: methodological systematic review.

    Science.gov (United States)

    Pibouleau, Leslie; Boutron, Isabelle; Reeves, Barnaby C; Nizard, Rémy; Ravaud, Philippe

    2009-11-17

    To compare the reporting of essential applicability data from randomised controlled trials and non-randomised studies evaluating four new orthopaedic surgical procedures. Medline and the Cochrane central register of controlled trials. All articles of comparative studies assessing total hip or knee arthroplasty carried out by a minimally invasive approach or computer assisted navigation system. Items judged to be essential for interpreting the applicability of findings about such procedures were identified by a survey of a sample of orthopaedic surgeons (77 of 512 completed the survey). Reports were evaluated for data describing these "essential" items and the number of centres and surgeons involved in the trials. When data on the number of centres and surgeons were not reported, the corresponding author of the selected trials was contacted. Results 84 articles were identified (38 randomised controlled trials, 46 non-randomised studies). The median percentage (interquartile range) of essential items reported for non-randomised studies compared with randomised controlled trials was 38% (25-63%) versus 44% (38-45%) for items about patients, 71% (43-86%) versus 71% (57-86%) for items considered essential for all interventions, and 38% (25-50%) versus 50% (25-50%) for items about the context of care. More than 80% of both study types were single centre studies, with one or two participating surgeons. The reporting of data related to the applicability of results was poor in published articles of both non-randomised studies and randomised controlled trials and did not differ by study design. The applicability of results from the trials and studies was similar in terms of number of centres and surgeons involved and the reproducibility of the intervention.

  11. The influence of low and moderate carotid stenosis on neurophysiologic status of patients undergoing on-pump coronary artery bypass grafting

    Directory of Open Access Journals (Sweden)

    Olga eTrubnikova

    2012-01-01

    Full Text Available Background: Significant (>70% extracranial stenosis of the internal carotid artery (ICA is a known risk factor for brain damage in patients with coronary heart disease (CHD undergoing coronary artery bypass grafting (CABG. There is no clear evidence of the low and moderate ICA stenoses influence on the neurophysiologic status of patients after CABG. This work was aimed at studying the influence ICA stenoses (<50% on the dynamics of neurophysiologic status in patients undergone CABG. Methods: We examined neurophysiologic functions and EEG in CHD patients (N=45 aged from 45 to 70 years. All patients were divided into two groups: with ICA stenosis (n=20 and without one (n= 25. Results: It was established that the group ICA stenosis had a negative dynamics of neurophysiologic status 6 months follow-up after CABG compared with patients without stenosis. Conclusions: Our results suggest that the presence of low and moderate ICA stenosis is one of the factors affecting the neurophysiologic status of CHD patients. It has been assumed that the patients with ≤50% ICA stenoses constitute a high-risk group for cerebral complications after on-pump CABG.

  12. Electronic voting to encourage interactive lectures: a randomised trial

    Directory of Open Access Journals (Sweden)

    Palmer Edward

    2007-07-01

    Full Text Available Abstract Background Electronic Voting Systems have been used for education in a variety of disciplines. Outcomes from these studies have been mixed. Because results from these studies have been mixed, we examined whether an EVS system could enhance a lecture's effect on educational outcomes. Methods A cohort of 127 Year 5 medical students at the University of Adelaide was stratified by gender, residency status and academic record then randomised into 2 groups of 64 and 63 students. Each group received consecutive 40-minute lectures on two clinical topics. One group received the EVS for both topics. The other group received traditional teaching only. Evaluation was undertaken with two, 15-question multiple-choice questionnaires (MCQ assessing knowledge and problem solving and undertaken as a written paper immediately before and after the lectures and repeated online 8–12 weeks later. Standardised institutional student questionnaires were completed for each lecture and independent observers assessed student behaviour during the lectures. Lecturer's opinions were assessed by a questionnaire developed for this study. Results Two-thirds of students randomised to EVS and 59% of students randomised to traditional lectures attended. One-half of the students in the EVS group and 41% in the traditional group completed all questionnaires. There was no difference in MCQ scores between EVS and traditional lectures (p = 0.785. The cervical cancer lectures showed higher student ranking in favour of EVS in all parameters. The breast cancer lectures showed higher ranking in favour of traditional lectures in 5 of 7 parameters (p Conclusion In this setting, EVS technology used in large group lectures did not offer significant advantages over the more traditional lecture format.

  13. A Randomised Controlled Trial of complete denture impression materials

    Science.gov (United States)

    Hyde, T.P.; Craddock, H.L.; Gray, J.C.; Pavitt, S.H.; Hulme, C.; Godfrey, M.; Fernandez, C.; Navarro-Coy, N.; Dillon, S.; Wright, J.; Brown, S.; Dukanovic, G.; Brunton, P.A.

    2014-01-01

    Objectives There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Methods Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Results Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7–67.3%, p silicone impressions were preferred by patients. Clinical significance Given the strength of the clinical findings within this paper, dentists should consider choosing silicone rather than alginate as their material of choice for secondary impressions for complete dentures. Trial Registration: ISRCTN 01528038.

 This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. PMID:24995473

  14. Randomised clinical trials with clinician-preferred treatment.

    Science.gov (United States)

    Korn, E L; Baumrind, S

    1991-01-19

    The standard design for randomised clinical trials may be inappropriate when the clinician believes that one of the treatments being tested is superior for the patient, or when the clinician has a preference for one of the treatments. For such instances the suggestion is that the patient is randomly allocated to treatment only when there is clinical disagreement about treatment of choice for that patient, and then the patient is assigned to a clinician who had thought that the regimen allocated is the one most appropriate for that patient.

  15. Pneumatic retinopexy versus scleral buckling: a randomised controlled trial.

    Science.gov (United States)

    Mulvihill, A; Fulcher, T; Datta, V; Acheson, R

    1996-01-01

    Pneumatic retinopexy (PR) is a technique for repairing certain retinal detachments which is easier to perform than conventional sceral buckling (SB) surgery but has comparable results. We performed a prospective, randomised, controlled trial to determine for ourselves whether PR is a safe and acceptable procedure. Twenty patients presenting consecutively with retinal detachments which fulfilled the selection criteria were randomised to have their detachments repaired by either PR or SB, ten patients in each group. The suitable patients had a single retinal break or small group of breaks of not greater than one clock hour in size, situated within the superior eight clock hours of retina. Patients with significant proliferative vitreoretinopathy or other fundus disorders were excluded. All patients in the PR group had local anaesthesia while all those in the SB group had general anaesthesia. Successful reattachment of the retina was achieved with one or more procedures in 90 percent of the PR group and in 100 percent of the SB group. We feel that narrowing the selection criteria for PR may further improve the success rate.

  16. A simple and robust LC-MS/MS method for quantification of free 3-nitrotyrosine in human plasma from patients receiving on-pump CABG surgery.

    Science.gov (United States)

    Hui, Yu; Wong, Michael; Zhao, Shuai Sherry; Love, Jennifer A; Ansley, David M; Chen, David D Y

    2012-02-01

    We have developed a simple, sensitive, and robust liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method to determine free 3-nitrotyrosine concentrations in human plasma of patients receiving on-pump coronary artery bypass grafting surgery. A one-step solid-phase extraction protocol was optimized to enrich the analyte at low nanomolar concentrations. The processed samples were analyzed by LC-MS/MS with a 2.1 × 100 mm Kinetex PFP column and a triple quadrupole mass spectrometer. The method was validated for 3-nitrotyrosine concentrations close to real patient plasma levels. The relative standard deviations or relative errors of the intraday and interday determinations were all within 10%. Limit of detection and limit of quantitation were determined to be 0.034 nM and 0.112 nM, respectively, while lower limit of quantitation was below 0.625 nM. No deterioration of the column performance was noticed after running a large number of patient samples. The results showed that the 3-nitrotyrosine concentrations in coronary sinus plasma samples were elevated after cardiopulmonary bypass (CPB) procedure. The pre-CPB and post-CPB concentrations of 3-nitrotyrosine in patient plasmas were 1.494 ± 0.107 nM and 2.167 ± 0.177 nM (mean ± SEM), respectively. Application of this method to more patients in clinical studies may help validate 3-nitrotyrosine as a meaningful biomarker for nitrosative stress and link patient characteristics, clinical outcomes, and cardioprotective treatments to endogenous nitrosative stress levels.

  17. A Comparative Study to Determine the Effect of Intravenous Magnesium on Postoperative Bleeding after on Pump CABG in Patients Receiving Pre-Operativc Aspirin

    Directory of Open Access Journals (Sweden)

    Sampa Dutta Gupta

    2009-01-01

    Full Text Available Hypomagnesaemia is a common complication after cardiopulmonary bypass (CPB and predisposes to the development of cardiac arrhythmias. Previous studies showed that intravenous magnesium reduces the incidence of postoperative cardiac arrhythmias but it also inhibits platelet function. Our aim was to compare the postoperative blood loss in patients not receiving magnesium after CPB with the group who received magnesium and to compare the requirement of blood, fresh frozen plasma (FFP and platelets within 24 hours after surgery. This prospective randomized controlled study was conducted in 80 adult patients on oral aspirin undergoing elective CABG requiring CPB. Group A patients had not received magnesium infusion after recovery from CPB. Group B patients received magnesium infusion after recovery from CPB. Postoperative bleeding was assessed in both the groups. All the data were statistically analyzed. There was a insignificant increase in 24 hours postoperative drainage in magnesium recipient group compared to control group ( p>0.05. Requirements of blood and blood products to maintain haematocrit and coagulation profile revealed insignificant ( p > 0.05.Increase in requirement of PRC, FFP and platelets in magnesium recipient patients than the control group. Incidence of atrial fibrillation ( Gr A 2.5%, Gr B 2.5% and atrial extrasystoles (Gr A 2.5%, Gr B 10% revealed comparable ( p > 0.05 between the groups, but incidence of ventricular arrhythmias were significantly ( p< 0.05 high in the patients of Gr A(17.5% than Gr B(5%. To conclude, magnesium may be administered to patients who continue pre-operative aspirin to undergo on-pump CABG surgery.

  18. Insulin-based strategies to prevent hypoglycaemia during and after exercise in adult patients with type 1 diabetes on pump therapy: the DIABRASPORT randomized study.

    Science.gov (United States)

    Franc, S; Daoudi, A; Pochat, A; Petit, M-H; Randazzo, C; Petit, C; Duclos, M; Penfornis, A; Pussard, E; Not, D; Heyman, E; Koukoui, F; Simon, C; Charpentier, G

    2015-12-01

    To validate strategies to prevent exercise-induced hypoglycaemia via insulin-dose adjustment in adult patients with type 1 diabetes (T1D) on pump therapy. A total of 20 patients randomly performed four 30-min late post-lunch (3 h after lunch) exercise sessions and a rest session: two moderate sessions [50% maximum oxygen consumption (VO2 max)] with 50 or 80% basal rate (BR) reduction during exercise + 2 h and two intense sessions (75% VO2 max) with 80% BR reduction or with their pump stopped. Two additional early post-lunch sessions (90 min after lunch) were analysed to compare hypoglycaemia incidence for BR reduction versus bolus reduction. In all, 100 late post-lunch sessions were analysed. Regardless of exercise type and BR reduction, no more hypoglycaemic events occurred in the period until the next morning than occurred after the rest sessions. In the afternoon, no more hypoglycaemic events occurred with 80% BR reduction/moderate exercise or with pump discontinuation/intense exercise than for the rest session, whereas more hypoglycaemic events occurred with 50% BR reduction/moderate exercise and 80% BR reduction/intense exercise. After early post-lunch exercise (n = 37), a trend towards fewer hypoglycaemic episodes was observed with bolus reduction versus BR reduction (p = 0.07). Mean blood glucose fell by ∼3.3 mmol/l after 30 min of exercise, irrespective of dose reduction, remaining stable until the next morning with no rebound hyperglycaemia. In adults with T1D, to limit the hypoglycaemic risk associated with 30 min of exercise 3 h after lunch, without carbohydrate supplements, the best options seem to be to reduce BR by 80% or to stop the pump for moderate or intense exercise, or for moderate exercise 90 min after lunch, to reduce the prandial bolus rather than the BR. © 2015 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

  19. Off-pump transapical closure of a mitral periprosthetic leak: a new approach to a difficult problem.

    Science.gov (United States)

    Gaia, Diego Felipe; Breda, João Roberto; Fischer, Claudio Henrique; Palma, José Honório

    2013-12-01

    A 60-year old male patient with multiple risk factors and two previous interventions over the mitral valve was admitted to the emergency unit with symptoms of cardiac failure. Initial examination revealed a competent mitral bioprosthesis with severe perivalvular mitral insufficiency. Based on previous experiences with transapical procedures, a transapical transcatheter closure of the perivalvular leak was performed. The apex was punctured with a 7 French introducer sheath, and a hydrophilic guidewire was advanced with the aid of a right Judkins catheter and positioned across the defect in the left atrium. Fluoroscopic and tridimensional transoesophageal echocardiography was used to guide the manoeuvre. Next, a long introducer sheath was advanced through the guidewire and positioned inside the left atrium. Two Amplatzer Vascular Plug II (St Jude Medical) were deployed, resulting in a significant reduction in the perivalvular leak. The procedure was considered to be successful. The patient regained consciousness, and the orotracheal tube was removed in the operating theatre. No neurological deficits were detected, and the patient was transferred to the intensive care unit. The patient recovered well and was transferred to the ward after 1 day. Discharge was accomplished after 4 days.

  20. Simple on-site assembled blower-mister device provides sufficient humidification and visualization in off-pump surgery.

    Science.gov (United States)

    Wippermann, Jens; Albes, Johannes M; Liebing, Kai; Breuer, Martin; Kaluza, Mirko; Strauch, Justus; Wahlers, Thorsten

    2006-09-01

    To effectively perform an anastomosis on a coronary artery under beating heart conditions, the anastomotic site must be cleared of blood to allow visualization for accurate suturing. We describe a simple, cost effective, on-site assembled blower-mister system.

  1. A pragmatic cluster randomised trial evaluating three implementation interventions

    Directory of Open Access Journals (Sweden)

    Rycroft-Malone Jo

    2012-08-01

    Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first

  2. Electronic voting to encourage interactive lectures: a randomised trial

    Science.gov (United States)

    2007-01-01

    Background Electronic Voting Systems have been used for education in a variety of disciplines. Outcomes from these studies have been mixed. Because results from these studies have been mixed, we examined whether an EVS system could enhance a lecture's effect on educational outcomes. Methods A cohort of 127 Year 5 medical students at the University of Adelaide was stratified by gender, residency status and academic record then randomised into 2 groups of 64 and 63 students. Each group received consecutive 40-minute lectures on two clinical topics. One group received the EVS for both topics. The other group received traditional teaching only. Evaluation was undertaken with two, 15-question multiple-choice questionnaires (MCQ) assessing knowledge and problem solving and undertaken as a written paper immediately before and after the lectures and repeated online 8–12 weeks later. Standardised institutional student questionnaires were completed for each lecture and independent observers assessed student behaviour during the lectures. Lecturer's opinions were assessed by a questionnaire developed for this study. Results Two-thirds of students randomised to EVS and 59% of students randomised to traditional lectures attended. One-half of the students in the EVS group and 41% in the traditional group completed all questionnaires. There was no difference in MCQ scores between EVS and traditional lectures (p = 0.785). The cervical cancer lectures showed higher student ranking in favour of EVS in all parameters. The breast cancer lectures showed higher ranking in favour of traditional lectures in 5 of 7 parameters (p lecturer-students interactions were increased in the EVS lecture for one lecturer and reduced for the other. Both lecturers felt that the EVS lectures were difficult to prepare, that they were able to keep to time in the traditional lectures, that the educational value of both lecture styles was similar, and that they were neutral-to-slightly favourably disposed

  3. Financial incentives for smoking cessation in pregnancy: randomised controlled trial.

    Science.gov (United States)

    Tappin, David; Bauld, Linda; Purves, David; Boyd, Kathleen; Sinclair, Lesley; MacAskill, Susan; McKell, Jennifer; Friel, Brenda; McConnachie, Alex; de Caestecker, Linda; Tannahill, Carol; Radley, Andrew; Coleman, Tim

    2015-01-27

    To assess the efficacy of a financial incentive added to routine specialist pregnancy stop smoking services versus routine care to help pregnant smokers quit. Phase II therapeutic exploratory single centre, individually randomised controlled parallel group superiority trial. One large health board area with a materially deprived, inner city population in the west of Scotland, United Kingdom. 612 self reported pregnant smokers in NHS Greater Glasgow and Clyde who were English speaking, at least 16 years of age, less than 24 weeks pregnant, and had an exhaled carbon monoxide breath test result of 7 ppm or more. 306 women were randomised to incentives and 306 to control. The control group received routine care, which was the offer of a face to face appointment to discuss smoking and cessation and, for those who attended and set a quit date, the offer of free nicotine replacement therapy for 10 weeks provided by pharmacy services, and four, weekly support phone calls. The intervention group received routine care plus the offer of up to £400 of shopping vouchers: £50 for attending a face to face appointment and setting a quit date; then another £50 if at four weeks' post-quit date exhaled carbon monoxide confirmed quitting; a further £100 was provided for continued validated abstinence of exhaled carbon monoxide after 12 weeks; a final £200 voucher was provided for validated abstinence of exhaled carbon monoxide at 34-38 weeks' gestation. The primary outcome was cotinine verified cessation at 34-38 weeks' gestation through saliva (incentives were documented. Significantly more smokers in the incentives group than control group stopped smoking: 69 (22.5%) versus 26 (8.6%). The relative risk of not smoking at the end of pregnancy was 2.63 (95% confidence interval 1.73 to 4.01) Pincentives need to be offered to achieve one extra quitter in late pregnancy) was 7.2 (95% confidence interval 5.1 to 12.2). The mean birth weight was 3140 g (SD 600 g) in the incentives group

  4. Education and coronary heart disease: mendelian randomisation study.

    Science.gov (United States)

    Tillmann, Taavi; Vaucher, Julien; Okbay, Aysu; Pikhart, Hynek; Peasey, Anne; Kubinova, Ruzena; Pajak, Andrzej; Tamosiunas, Abdonas; Malyutina, Sofia; Hartwig, Fernando Pires; Fischer, Krista; Veronesi, Giovanni; Palmer, Tom; Bowden, Jack; Davey Smith, George; Bobak, Martin; Holmes, Michael V

    2017-08-30

    Objective To determine whether educational attainment is a causal risk factor in the development of coronary heart disease.Design Mendelian randomisation study, using genetic data as proxies for education to minimise confounding.Setting The main analysis used genetic data from two large consortia (CARDIoGRAMplusC4D and SSGAC), comprising 112 studies from predominantly high income countries. Findings from mendelian randomisation analyses were then compared against results from traditional observational studies (164 170 participants). Finally, genetic data from six additional consortia were analysed to investigate whether longer education can causally alter the common cardiovascular risk factors.Participants The main analysis was of 543 733 men and women (from CARDIoGRAMplusC4D and SSGAC), predominantly of European origin.Exposure A one standard deviation increase in the genetic predisposition towards higher education (3.6 years of additional schooling), measured by 162 genetic variants that have been previously associated with education.Main outcome measure Combined fatal and non-fatal coronary heart disease (63 746 events in CARDIoGRAMplusC4D).Results Genetic predisposition towards 3.6 years of additional education was associated with a one third lower risk of coronary heart disease (odds ratio 0.67, 95% confidence interval 0.59 to 0.77; P=3×10(-8)). This was comparable to findings from traditional observational studies (prevalence odds ratio 0.73, 0.68 to 0.78; incidence odds ratio 0.80, 0.76 to 0.83). Sensitivity analyses were consistent with a causal interpretation in which major bias from genetic pleiotropy was unlikely, although this remains an untestable possibility. Genetic predisposition towards longer education was additionally associated with less smoking, lower body mass index, and a favourable blood lipid profile.Conclusions This mendelian randomisation study found support for the hypothesis that low education is a causal risk factor in the

  5. Electronic voting to encourage interactive lectures: a randomised trial.

    Science.gov (United States)

    Duggan, Paul M; Palmer, Edward; Devitt, Peter

    2007-07-27

    Electronic Voting Systems have been used for education in a variety of disciplines. Outcomes from these studies have been mixed. Because results from these studies have been mixed, we examined whether an EVS system could enhance a lecture's effect on educational outcomes. A cohort of 127 Year 5 medical students at the University of Adelaide was stratified by gender, residency status and academic record then randomised into 2 groups of 64 and 63 students. Each group received consecutive 40-minute lectures on two clinical topics. One group received the EVS for both topics. The other group received traditional teaching only. Evaluation was undertaken with two, 15-question multiple-choice questionnaires (MCQ) assessing knowledge and problem solving and undertaken as a written paper immediately before and after the lectures and repeated online 8-12 weeks later. Standardised institutional student questionnaires were completed for each lecture and independent observers assessed student behaviour during the lectures. Lecturer's opinions were assessed by a questionnaire developed for this study. Two-thirds of students randomised to EVS and 59% of students randomised to traditional lectures attended. One-half of the students in the EVS group and 41% in the traditional group completed all questionnaires. There was no difference in MCQ scores between EVS and traditional lectures (p = 0.785). The cervical cancer lectures showed higher student ranking in favour of EVS in all parameters. The breast cancer lectures showed higher ranking in favour of traditional lectures in 5 of 7 parameters (p higher-order lecturer-students interactions were increased in the EVS lecture for one lecturer and reduced for the other. Both lecturers felt that the EVS lectures were difficult to prepare, that they were able to keep to time in the traditional lectures, that the educational value of both lecture styles was similar, and that they were neutral-to-slightly favourably disposed to continue with

  6. Promotion of physical activity and fitness in sedentary patients with Parkinson's disease : randomised controlled trial

    NARCIS (Netherlands)

    van Nimwegen, Marlies; Speelman, Arlene D.; Overeem, Sebastiaan; van de Warrenburg, Bart P.; Smulders, Katrijn; Dontje, Manon L.; Borm, George F.; Backx, Frank J. G.; Bloem, Bastiaan R.; Munneke, Marten

    2013-01-01

    Objective To evaluate whether a multifaceted behavioural change programme increases physical activities in patients with Parkinson's disease. Design Multicentre randomised controlled trial. Setting 32 community hospitals in the Netherlands, collaborating in a nationwide network (ParkinsonNet). Parti

  7. Promotion of physical activity and fitness in sedentary patients with Parkinson's disease : randomised controlled trial

    NARCIS (Netherlands)

    van Nimwegen, Marlies; Speelman, Arlene D.; Overeem, Sebastiaan; van de Warrenburg, Bart P.; Smulders, Katrijn; Dontje, Manon L.; Borm, George F.; Backx, Frank J. G.; Bloem, Bastiaan R.; Munneke, Marten

    2013-01-01

    Objective To evaluate whether a multifaceted behavioural change programme increases physical activities in patients with Parkinson's disease. Design Multicentre randomised controlled trial. Setting 32 community hospitals in the Netherlands, collaborating in a nationwide network (ParkinsonNet). Parti

  8. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M; Bloemenkamp, Kitty W; Franssen, Maureen T; Papatsonis, Dimitri N; Hajenius, Petra J; Hollmann, Markus W; Woiski, Mallory D; Porath, Martina; van den Berg, Hans J; van Beek, Erik; Borchert, Odette W H M; Schuitemaker, Nico; Sikkema, J Marko; Kuipers, A H M; Logtenberg, Sabine L M; van der Salm, Paulien C M; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M Elske; le Cessie, Saskia; van Lith, Jan M; Struys, Michel M; Mol, Ben Willem J; Dahan, Albert; Middeldorp, Johanna M; Oude Rengerink, K

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an interm

  9. Practical aspects of conducting a pragmatic randomised trial in primary care: patient recruitment and outcome assessment

    NARCIS (Netherlands)

    D.A.W.M. van der Windt (Daniëlle); B.W. Koes (Bart); M. van Aarst; M.A. Heemskerk; L.M. Bouter (Lex)

    2000-01-01

    textabstractBACKGROUND: Conducting a pragmatic randomised trial in primary care is often accompanied by practical problems. Such problems are seldom reported and may constitute useful lessons for researchers planning future trials. AIM: To address the difficulties invol

  10. [Effects of a stepwise approach to behavioural problems in dementia: a cluster randomised controlled trial

    NARCIS (Netherlands)

    Pieper, M.J.; Francke, A.L.; Steen, J.T. van der; Scherder, E.J.; Twisk, J.W.R.; Kovach, C.R.; Achterberg, W.P.

    2016-01-01

    OBJECTIVE: To investigate whether implementation of a stepwise multidisciplinary intervention ('STA OP!' ['STAND UP!']) is effective in reducing behavioural problems and depressive symptoms in nursing home residents with advanced dementia. DESIGN: Cluster randomised controlled trial. METHOD: We

  11. The RESOLVE Trial for people with chronic low back pain: protocol for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Matthew K Bagg

    2017-01-01

    Full Text Available Introduction: Low back pain is the leading worldwide cause of disability, and results in significant personal hardship. Most available treatments, when tested in high-quality randomised, controlled trials

  12. Representation of people with intellectual disabilities in randomised controlled trials on antipsychotic treatment for behavioural problems

    NARCIS (Netherlands)

    Scheifes, A.; Stolker, J.J.; Nijman, H.L.I.; Egberts, A.C.G.; Heerdink, E.R.

    2011-01-01

    Background Behavioural problems are common in people with intellectual disability (ID) and are often treated with antipsychotics. Aim To establish the frequency and characteristics of people with ID included in randomised controlled trials (RCTs) on antipsychotic treatment for behavioural problems

  13. Aprotinin and transfusion requirements in orthotopic liver transplantation : a multicentre randomised double-blind study

    NARCIS (Netherlands)

    Porte, RJ; Molenaar, IQ; Begliomini, B; Groenland, THN; Januszkiewicz, A; Lindgren, L; Palareti, G; Hermans, J; Terpstra, OT

    2000-01-01

    Background Intraoperative hyperfibrinolysis contributes to bleeding during adult orthotopic liver transplantation. We aimed to find out whether aprotinin, a potent antifibrinolytic agent, reduces blood loss and transfusion requirements. Methods We did a randomised, double-blind placebo-controlled tr

  14. Rizatriptan vs. ibuprofen in migraine: a randomised placebo-controlled trial

    OpenAIRE

    Misra, Usha Kant; Kalita, Jayantee; Yadav, Rama Kant

    2007-01-01

    The objective of this study was to compare the efficacy of rizatriptan and ibuprofen in migraine. The study was a randomised placebo-controlled trial in a tertiary care teaching hospital. Migraine patients with

  15. Supervised exercise therapy versus usual care for patellofemoral pain syndrome : an open label randomised controlled trial

    NARCIS (Netherlands)

    van Linschoten, R.; van Middelkoop, M.; Berger, M. Y.; Heintjes, E. M.; Verhaar, J. A. N.; Willemsen, S. P.; Koes, B. W.; Bierma-Zeinstra, S. M.

    2009-01-01

    Objective To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome. Design Open label randomised controlled trial. Setting General practice and sport physician practice. Participants

  16. Supervised exercise therapy versus usual care for patellofemoral pain syndrome : an open label randomised controlled trial

    NARCIS (Netherlands)

    van Linschoten, R.; van Middelkoop, M.; Berger, M. Y.; Heintjes, E. M.; Verhaar, J. A. N.; Willemsen, S. P.; Koes, B. W.; Bierma-Zeinstra, S. M.

    2009-01-01

    Objective To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome. Design Open label randomised controlled trial. Setting General practice and sport physician practice. Participants

  17. Labour pain with remifentanil patient-controlled analgesia versus epidural analgesia : a randomised equivalence trial

    NARCIS (Netherlands)

    Logtenberg, Slm; Oude Rengerink, K; Verhoeven, C J; Freeman, L M; van den Akker, Esa; Godfried, M B; van Beek, E; Borchert, Owhm; Schuitemaker, N; van Woerkens, Ecsm; Hostijn, I; Middeldorp, J M; van der Post, J A; Mol, B W

    OBJECTIVE: To distinguish satisfaction with pain relief using remifentanil patient-controlled analgesia (RPCA) compared with epidural analgesia (EA) in low-risk labouring women. DESIGN: Randomised controlled equivalence trial. SETTING: Eighteen midwifery practices and six hospitals in the

  18. Choosing a control intervention for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Djulbegovic Benjamin

    2003-04-01

    Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

  19. Careful science? Bodywork and care practices in randomised clinical trials

    DEFF Research Database (Denmark)

    Jespersen, Astrid Pernille; Bønnelycke, Julie; Eriksen, Hanne Hellerup

    2013-01-01

    the focus to reflect everyday practices would foster better targeted public health campaigns. This article is based on our participation in FINE, a multidisciplinary Danish research project. The core methodology of FINE was a randomised controlled trial in which 61 moderately overweight men were put...... into different exercise groups. In this article we analyse the scientific work of the trial as representing entangled processes of bodywork, where data are extracted and objectified bodies are manipulated and care practices address the emotional, social and mundane aspects of the participants' everyday lives....... Care practices are an inherent part of producing scientific facts but they are removed from the recognised results of scientific practice and thus from common public health recommendations. However, knowledge about the strategic use of care practices in lifestyle interventions is important for public...

  20. Bronchodilators for treatment of mild bronchiolitis: a factorial randomised trial.

    Science.gov (United States)

    Wang, E E; Milner, R; Allen, U; Maj, H

    1992-01-01

    A randomised double blind trial was conducted to determine the efficacy of inhaled bronchodilators, salbutamol and ipratropium bromide, compared with placebo in the treatment of bronchiolitis. Patients, who were 2 months to 2 years of age and without underlying cardiac or pulmonary disease, received drug 1 (salbutamol or saline placebo) followed one hour later by drug 2 (ipratropium bromide or placebo). Both agents were administered every four hours. The patients were allocated to one of four groups according to a factorial design. The four groups were similar in demographic characteristics, initial oxygenation, and clinical score. The change in oxygen saturation of recipients of both agents was significantly better than that of recipients of salbutamol alone or ipratropium bromide alone. This change, however, was not statistically different from that of the control group. No difference was observed in the clinical score or hospital duration. Inhaled bronchodilators did not improve the condition of hospitalised mild bronchiolitis. PMID:1533504

  1. Reported challenges in nurse-led randomised controlled trials

    DEFF Research Database (Denmark)

    Wang Vedelø, Tina; Lomborg, Kirsten

    2011-01-01

    , nursing research, nursing, research, challenges, barriers, nurse's role, nurse attitude, attitude of health personnel. Findings: The literature on reported challenges and barriers between 1999 and 2009 showed that the most often experienced problems were (i) sufficient patient recruitment, (ii......Aims: The purpose of this integrative literature review was to explore and discuss the methodological challenges nurse researchers report after conducting nurse-led randomised controlled trials in clinical hospital settings. Our research questions were (i) what are the most commonly experienced...... and the clinical nursing staff. Two lessons learned from this integrative review can be highlighted. First, we recommend researchers openly to share their experiences of barriers and challenges. They should describe factors that may have inhibited the desired outcome. Second, efforts to improve the collaboration...

  2. Is voice therapy an effective treatment for dysphonia? A randomised controlled trial

    OpenAIRE

    MacKenzie, K.; Millar, A; Wilson, J. A.; Sellars, C.; Deary, I. J.

    2001-01-01

    OBJECTIVES: To assess the overall efficacy of voice therapy for dysphonia. DESIGN: Single blind randomised controlled trial. SETTING: Outpatient clinic in a teaching hospital. Participants: 204 outpatients aged 17-87 with a primary symptom of persistent hoarseness for at least two months. INTERVENTIONS: After baseline assessments, patients were randomised to six weeks of either voice therapy or no treatment. Assessments were repeated at six weeks on the 145 (71%) patients who continued to thi...

  3. Barriers to the conduct of randomised clinical trials within all disease areas

    DEFF Research Database (Denmark)

    Djurisic, Snezana; Rath, Ana; Gaber, Sabrina

    2017-01-01

    BACKGROUND: Randomised clinical trials are key to advancing medical knowledge and to enhancing patient care, but major barriers to their conduct exist. The present paper presents some of these barriers. METHODS: We performed systematic literature searches and internal European Clinical Research...... and trial methodology; lack of funding; excessive monitoring; restrictive privacy law and lack of transparency; complex regulatory requirements; and inadequate infrastructures. There is a need for more pragmatic randomised clinical trials conducted with low risks of systematic and random errors...

  4. A randomised study evaluating the use of pyridoxine to avoid capecitabine dose modifications

    OpenAIRE

    2012-01-01

    Background: Pyridoxine is frequently used to treat capecitabine-induced hand–foot syndrome (HFS), although the evidence of benefit is lacking. We performed a randomised placebo-controlled trial to determine whether pyridoxine could avoid the need for capecitabine dose modifications and improve outcomes. Methods: A total of 106 patients planned for palliative single-agent capecitabine (53 in each arm, 65%/ 35% colorectal/breast cancer) were randomised to receive either concomitant pyridoxine (...

  5. In veterinary trials reporting and communication regarding randomisation procedures is suboptimal.

    Science.gov (United States)

    Di Girolamo, N; Giuffrida, M A; Winter, A L; Meursinge Reynders, R

    2017-08-19

    To evaluate randomisation mechanisms in the veterinary literature, all trials defined as 'randomised' were extracted from five leading veterinary journals for the year 2013. Three blinded investigators evaluated (1) if the random sequence generation was actually non-random, and (2) whether method (CONSORT item 8A) and (3) type of randomisation (CONSORT item 8B) were reported. Trialists were contacted via email to establish (1) willingness to respond to questions on randomisation procedures, (2) whether reporting of randomisation improved following a suggestion to use the CONSORT 2010 guideline. Seven per cent ((95 per cent CI 2 to 12 per cent); 8/114) of the trials defined as 'randomised' explicitly used methods that are considered non-random. Almost half of the trials (49 per cent (40 to 59 per cent); 52/106) did not report any mechanism of randomisation. Only 13 trials (12.3 per cent (6 to 19 per cent); 13/106) reported both items. 39 of 114 (34.2 per cent) trialists contacted were willing to respond to further questions on randomisation mechanisms; 4 (3.5 per cent) trialists were unwilling and 71 (62.3 per cent) trialists did not respond. Email correspondence resulted in a mean clarification of 0.7 items (95 per cent CI 0.4 to 1.0) for the 15 trials for trialists that replied. Improved adherence to CONSORT guidelines and trialists communication is imperative to increase the quality of published evidence in veterinary medicine and to reduce research waste. British Veterinary Association.

  6. Early treatment of posterior crossbite - a randomised clinical trial

    Science.gov (United States)

    2013-01-01

    Background The aim of this randomised clinical trial was to assess the effect of early orthodontic treatment in contrast to normal growth effects for functional unilateral posterior crossbite in the late deciduous and early mixed dentition by means of three-dimensional digital model analysis. Methods This randomised clinical trial was assessed to analyse the orthodontic treatment effects for patients with functional unilateral posterior crossbite in the late deciduous and early mixed dentition using a two-step procedure: initial maxillary expansion followed by a U-bow activator therapy. In the treatment group 31 patients and in the control group 35 patients with a mean age of 7.3 years (SD 2.1) were monitored. The time between the initial assessment (T1) and the follow-up (T2) was one year. The orthodontic analysis was done by a three-dimensional digital model analysis. Using the ‘Digimodel’ software, the orthodontic measurements in the maxilla and mandible and for the midline deviation, the overjet and overbite were recorded. Results Significant differences between the control and the therapy group at T2 were detected for the anterior, median and posterior transversal dimensions of the maxilla, the palatal depth, the palatal base arch length, the maxillary arch length and inclination, the midline deviation, the overjet and the overbite. Conclusions Orthodontic treatment of a functional unilateral posterior crossbite with a bonded maxillary expansion device followed by U-bow activator therapy in the late deciduous and early mixed dentition is an effective therapeutic method, as evidenced by the results of this RCT. It leads to three-dimensional therapeutically induced maxillary growth effects. Dental occlusion is significantly improved, and the prognosis for normal craniofacial growth is enhanced. Trial registration Registration trial DRKS00003497 on DRKS PMID:23339736

  7. Statistical issues in randomised controlled trials: a narrative synthesis

    Directory of Open Access Journals (Sweden)

    Bolaji Emmanuel Egbewale

    2015-05-01

    Full Text Available Randomised controlled trials (RCT s are gold standard in the evaluation of treatment efficacy in medical investigations, only if well designed and implemented. Till date, distorted views and misapplications of statistical procedures involved in RCTs are still in practice. Hence, clarification of concepts and acceptable practices related to certain statistical issues involved in the design, conduct and reporting of randomised controlled trials is needed. This narrative synthesis aimed at providing succinct but clear information on the concepts and practices of selected statistical issues in RCT s to inform correct applications. The use of tests of significance is no longer acceptable as means to compare baseline similarity between treatment groups and in determining which covariate(s should be included in the model for adjustment. Distribution of baseline attributes simply presented in tabular form is however, rather preferred. Regarding covariate selection, such approach that makes use of information on the degree of correlation between the covariate(s and the outcome variable is more in tandem with statistical principle(s than that based on tests of significance. Stratification and minimisation are not alternatives to covariate adjusted analysis; in fact they establish the need for one. Intention-to-treat is the preferred approach for the evaluation of primary outcome measures and researchers have responsibility to report whether or not the procedure was followed. A major use of results from subgroup analysis is to generate hypothesis for future clinical trials. Since RCT s are gold standard in the comparison of medical interventions, researchers cannot afford the practices of distorted allocation or statistical procedures in this all important experimental design method.

  8. Laparoscopic cholecystectomy under spinal anaesthesia: A prospective, randomised study

    Directory of Open Access Journals (Sweden)

    Sangeeta Tiwari

    2013-01-01

    Full Text Available Context: Spinal anaesthesia has been reported as an alternative to general anaesthesia for performing laparoscopic cholecystectomy (LC. Aims: Study aimed to evaluate efficacy, safety and cost benefit of conducting laparoscopic cholecystectomy under spinal anaesthesia (SA in comparison to general anaesthesia(GA Settings and Design: A prospective, randomised study conducted over a two year period at an urban, non teaching hospital. Materials and Methods: Patients meeting inclusion criteria e randomised into two groups .Group A and Group B received general and spinal anaesthesia by standardised techniques. Both groups underwent standard four port laparoscopic cholecystectomy. Mean anaesthesia time, pneumoperitoneum time and surgery time defined primary outcome measures. Intraoperative events and post operative pain score were secondary outcome measure. Statistical Analysis Used: The Student t test, Pearson′s chi-square test and Fisher exact test. Results: Out of 235 cases enrolled in the study, 114 cases in Group A and 110 in Group B analysed. Mean anaesthesia time appeared to be more in the GA group (49.45 vs. 40.64, P = 0.02 while pneumoperitoneum time and corresponding the total surgery time was slightly longer in the SA group. 27/117 cases who received SA experienced intraoperative events, four significant enough to convert to GA. No postoperative complications noted in either group. Pain relief significantly more in SA group in immediate post operative period (06 and 12 hours but same as GA group at time of discharge (24 hours. No late postoperative complication or readmission noted in either group. Conclusion: Laparoscopic cholecystectomy done under spinal anaesthesia as a routine anaesthesia of choice is feasible and safe. Spinal anaesthesia can be recommended to be the anaesthesia technique of choice for conducting laparoscopic cholecystectomy in hospital setups in developing countries where cost factor is a major factor.

  9. Statistical issues in randomised controlled trials: a narrative synthesis

    Institute of Scientific and Technical Information of China (English)

    Bolaji; Emmanuel; Egbewale

    2015-01-01

    Randomised controlled trials(RCTs) are gold standard in the evaluation of treatment efficacy in medical investigations, only if well designed and implemented. Till date, distorted views and misapplications of statistical procedures involved in RCTs are still in practice. Hence, clarification of concepts and acceptable practices related to certain statistical issues involved in the design, conduct and reporting of randomised controlled trials is needed. This narrative synthesis aimed at providing succinct but clear information on the concepts and practices of selected statistical issues in RCTs to inform correct applications. The use of tests of significance is no longer acceptable as means to compare baseline similarity between treatment groups and in determining which covariate(s) should be included in the model for adjustment. Distribution of baseline attributes simply presented in tabular form is however, rather preferred. Regarding covariate selection, such approach that makes use of information on the degree of correlation between the covariate(s) and the outcome variable is more in tandem with statistical principle(s) than that based on tests of significance. Stratification and minimisation are not alternatives to covariate adjusted analysis; in fact they establish the need for one. Intention-totreat is the preferred approach for the evaluation of primary outcome measures and researchers have responsibility to report whether or not the procedure was followed. A major use of results from subgroup analysis is to generate hypothesis for future clinical trials. Since RCTs are gold standard in the comparison of medical interventions, researchers cannot afford the practices of distorted allocation or statistical procedures in this all important experimental design method.

  10. Significant reduction in blood loss in patients undergoing minimal extracorporeal circulation

    NARCIS (Netherlands)

    Gerritsen, W. B.; van Boven, W. J.; Smelt, M.; Morshuis, W. J.; van Dongen, H. P.; Haas, F. J.; Aarts, L. P.

    2006-01-01

    Several recent studies have shown differences in blood loss and allogeneic transfusion requirements between on-pump and off-pump coronary artery bypass grafting (CABG). Recently a new concept, the mini-extracorporeal circulation, was introduced to minimize the side effects of extracorporeal circulat

  11. Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform.

    Science.gov (United States)

    Treweek, Shaun; Altman, Doug G; Bower, Peter; Campbell, Marion; Chalmers, Iain; Cotton, Seonaidh; Craig, Peter; Crosby, David; Davidson, Peter; Devane, Declan; Duley, Lelia; Dunn, Janet; Elbourne, Diana; Farrell, Barbara; Gamble, Carrol; Gillies, Katie; Hood, Kerry; Lang, Trudie; Littleford, Roberta; Loudon, Kirsty; McDonald, Alison; McPherson, Gladys; Nelson, Annmarie; Norrie, John; Ramsay, Craig; Sandercock, Peter; Shanahan, Daniel R; Summerskill, William; Sydes, Matt; Williamson, Paula; Clarke, Mike

    2015-06-05

    Randomised trials are at the heart of evidence-based healthcare, but the methods and infrastructure for conducting these sometimes complex studies are largely evidence free. Trial Forge ( www.trialforge.org ) is an initiative that aims to increase the evidence base for trial decision making and, in doing so, to improve trial efficiency.This paper summarises a one-day workshop held in Edinburgh on 10 July 2014 to discuss Trial Forge and how to advance this initiative. We first outline the problem of inefficiency in randomised trials and go on to describe Trial Forge. We present participants' views on the processes in the life of a randomised trial that should be covered by Trial Forge.General support existed at the workshop for the Trial Forge approach to increase the evidence base for making randomised trial decisions and for improving trial efficiency. Agreed upon key processes included choosing the right research question; logistical planning for delivery, training of staff, recruitment, and retention; data management and dissemination; and close down. The process of linking to existing initiatives where possible was considered crucial. Trial Forge will not be a guideline or a checklist but a 'go to' website for research on randomised trials methods, with a linked programme of applied methodology research, coupled to an effective evidence-dissemination process. Moreover, it will support an informal network of interested trialists who meet virtually (online) and occasionally in person to build capacity and knowledge in the design and conduct of efficient randomised trials.Some of the resources invested in randomised trials are wasted because of limited evidence upon which to base many aspects of design, conduct, analysis, and reporting of clinical trials. Trial Forge will help to address this lack of evidence.

  12. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

    Science.gov (United States)

    Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2014-07-16

    To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

  13. Should desperate volunteers be included in randomised controlled trials?

    Science.gov (United States)

    Allmark, P; Mason, S

    2006-09-01

    Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguments that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. Third, desperate volunteers do not give proper consent: effectively, they are coerced. This paper responds by advocating a notion of equipoise based on expert knowledge and widely shared values. Where such collective, expert equipoise exists there is a prima facie case for an RCT. Next the paper argues that trial entry does not involve clinicians disavowing their therapeutic obligation; individualised care based on insufficient evidence is not in patients best interest. Finally, it argues that where equipoise exists it is acceptable to limit access to experimental agents; desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire.

  14. Impact of industry collaboration on randomised controlled trials in oncology.

    Science.gov (United States)

    Linker, Anne; Yang, Annie; Roper, Nitin; Whitaker, Evans; Korenstein, Deborah

    2017-02-01

    Industry funders can simply provide money or collaborate in trial design, analysis or reporting of clinical trials. Our aim was to assess the impact of industry collaboration on trial methodology and results of randomised controlled trials (RCT). We searched PubMed for oncology RCTs published May 2013 to December 2015 in peer-reviewed journals with impact factor > 5 requiring reporting of funder role. Two authors extracted methodologic (primary end-point; blinding of the patient, clinician and outcomes assessor; and analysis) and outcome data. We used descriptive statistics and two-sided Fisher exact tests to compare characteristics of trials with collaboration, with industry funding only, and without industry funding. We included 224 trials. Compared to those without industry funding, trials with collaboration used more placebo control (RR 3·59, 95% CI [1·88-6·83], p industry collaboration were more likely to use some high-quality methods than those without industry funding, with similar rates of positive results. Our findings suggest that collaboration is not associated with trial outcomes and that mandatory disclosure of funder roles may mitigate bias. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. Self Management Activation Randomised Trial for Prostatitis (SMART-P: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Rochester Mark

    2011-09-01

    Full Text Available Abstract Background Chronic prostatitis otherwise known as chronic pelvic pain syndrome is a common urological diagnosis that causes many men significant morbidity and has a detrimental effect on their quality of life. Standard treatment with antibiotics and simple analgesia are often ineffective and many patients are managed by the chronic pain services. Cognitive behavioural therapy has been shown to be helpful in the management of many chronic diseases and has recently been proposed as an effective treatment for chronic prostatitis. Furthermore, a self management programme administered to groups of men with lower urinary tract symptoms has been shown to be more effective than standard treatments including surgery. Therefore, we have developed a cognitive behavioural therapy programme specifically for men with chronic prostatitis. This novel treatment approach will be compared to conventional therapy in the pain clinic such as atypical analgesia and local anaesthetic injections in the context of a randomised controlled trial. Methods/Design Men will be recruited from general urology outpatient clinics following the exclusion of other diagnoses that could be responsible for their symptoms. Men will be randomised to attend either a self management healthcare and education programme or to pain clinic referral alone. The self management programme will be administered by a clinical psychologist to small groups of men over six consecutive weekly sessions each lasting two hours. Patients will be taught techniques of problem-solving and goal-setting and will learn coping mechanisms and how to modify catastrophic cognition. The primary outcome will be change from baseline in the National Institute of Health Chronic Prostatitis Symptom Index, a validated instrument for the assessment of men with chronic prostatitis. Secondary outcomes include generic quality of life scores and analgesic and drug usage. Outcomes will be assessed at 2, 6 and 12 months

  16. Self Management Activation Randomised Trial for Prostatitis (SMART-P): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Rochester, Mark; Armitage, James; Sanders, Mark; Christmas, Paula

    2011-09-26

    Chronic prostatitis otherwise known as chronic pelvic pain syndrome is a common urological diagnosis that causes many men significant morbidity and has a detrimental effect on their quality of life. Standard treatment with antibiotics and simple analgesia are often ineffective and many patients are managed by the chronic pain services.Cognitive behavioural therapy has been shown to be helpful in the management of many chronic diseases and has recently been proposed as an effective treatment for chronic prostatitis. Furthermore, a self management programme administered to groups of men with lower urinary tract symptoms has been shown to be more effective than standard treatments including surgery.Therefore, we have developed a cognitive behavioural therapy programme specifically for men with chronic prostatitis. This novel treatment approach will be compared to conventional therapy in the pain clinic such as atypical analgesia and local anaesthetic injections in the context of a randomised controlled trial. Men will be recruited from general urology outpatient clinics following the exclusion of other diagnoses that could be responsible for their symptoms. Men will be randomised to attend either a self management healthcare and education programme or to pain clinic referral alone. The self management programme will be administered by a clinical psychologist to small groups of men over six consecutive weekly sessions each lasting two hours. Patients will be taught techniques of problem-solving and goal-setting and will learn coping mechanisms and how to modify catastrophic cognition.The primary outcome will be change from baseline in the National Institute of Health Chronic Prostatitis Symptom Index, a validated instrument for the assessment of men with chronic prostatitis. Secondary outcomes include generic quality of life scores and analgesic and drug usage. Outcomes will be assessed at 2, 6 and 12 months. If this group administered self management programme is

  17. Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma : multicentre randomised trial

    NARCIS (Netherlands)

    Creutzberg, CL; van Putten, WLJ; Koper, PCM; Lybeert, MLM; Jobsen, JJ; Warlam-Rodenhuis, CC; De Winter, KAJ; Lutgens, LCHW; van den Bergh, ACM; van de Steen-Banasik, E; Beerman, H; van Lent, M

    2000-01-01

    Background Postoperative radiotherapy for international Federation of Gynaecology and Obstetrics (FIGO) stage-1 endometrial carcinoma is a subject of controversy due to the low relapse rate and the lack of data from randomised trials. We did a multicentre prospective randomised trial to find whether

  18. Prednisone versus prednisone plus ciclosporin versus prednisone plus methotrexate in new-onset juvenile dermatomyositis : a randomised trial

    NARCIS (Netherlands)

    Ruperto, Nicolino; Pistorio, Angela; Oliveira, Sheila; Zulian, Francesco; Cuttica, Ruben; Ravelli, Angelo; Fischbach, Michel; Magnusson, Bo; Sterba, Gary; Avcin, Tadej; Brochard, Karine; Corona, Fabrizia; Dressler, Frank; Gerloni, Valeria; Apaz, Maria T; Bracaglia, Claudia; Cespedes-Cruz, Adriana; Cimaz, Rolando; Couillault, Gerard; Joos, Rik; Quartier, Pierre; Russo, Ricardo; Tardieu, Marc; Wulffraat, Nico; Bica, Blanca; Dolezalova, Pavla; Ferriani, Virginia; Flato, Berit; Bernard-Medina, Ana G; Herlin, Troels; Trachana, Maria; Meini, Antonella; Allain-Launay, Emma; Pilkington, Clarissa; Vargova, Veronika; Wouters, Carine; Angioloni, Simona; Martini, Alberto

    2016-01-01

    BACKGROUND: Most data for treatment of dermatomyositis and juvenile dermatomyositis are from anecdotal, non-randomised case series. We aimed to compare, in a randomised trial, the efficacy and safety of prednisone alone with that of prednisone plus either methotrexate or ciclosporin in children with

  19. Cervical occlusion in women with cervical insufficiency: protocol for a randomised, controlled trial with cerclage, with and without cervical occlusion

    DEFF Research Database (Denmark)

    Secher, Niels Jørgen; MaCormack, CD; Weber, Tom;

    2007-01-01

    , without the membranes being exposed to the vagina. 6. Tertiary cerclage: Short cervix, membranes exposed to the vagina. Observational study: Eligible women who refuse to be randomised will participate in an observational study. 7. Repeat/requested cervical occlusion. METHODS: The women will be randomised...

  20. The effects of a randomised multi-centre trial and international accreditation on availability and quality of clinical guidelines

    DEFF Research Database (Denmark)

    Juul, AB; Gluud, C; Wetterslev, J;

    2005-01-01

    To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation.......To examine the availability and quality of clinical guidelines on perioperative diabetes care in hospital units before and after a randomised clinical trial (RCT) and international accreditation....

  1. Randomised comparison of leucocyte-depleted versus buffy-coat-poor blood transfusion and complications after colorectal surgery

    DEFF Research Database (Denmark)

    Jensen, L S; Kissmeyer-Nielsen, P; Wolff, B;

    1996-01-01

    surgery were randomised to receive buffy-coat poor (n = 299) or filtered leucocyte-depleted red-cells (n = 290) when transfusion was indicated. 260 patients actually received blood transfusion. Three patients were excluded from analysis. FINDINGS: The 142 patients randomised to and transfused with buffy...

  2. Infant feeding bottle design, growth and behaviour: results from a randomised trial

    Directory of Open Access Journals (Sweden)

    Fewtrell MS

    2012-03-01

    Full Text Available Abstract Background Whether the design of an anti-vacuum infant feeding bottle influences infant milk intake, growth or behavior is unknown, and was the subject of this randomized trial. Methods Subjects 63 (36 male healthy, exclusively formula-fed term infants. Intervention Randomisation to use Bottle A (n = 31, one-way air valve: Philips Avent versus Bottle B (n = 32, internal venting system: Dr Browns. 74 breast-fed reference infants were recruited, with randomisation (n = 24 to bottle A (n = 11 or B (n = 13 if bottle-feeding was subsequently introduced. Randomisation stratified by gender and parity; computer-based telephone randomisation by independent clinical trials unit. Setting Infant home. Primary outcome measure infant weight gain to 4 weeks. Secondary outcomes (i milk intake (ii infant behaviour measured at 2 weeks (validated 3-day diary; (iii risk of infection; (iv continuation of breastfeeding following introduction of mixed feeding. Results Number analysed for primary outcome Bottle A n = 29, Bottle B n = 25. Primary outcome There was no significant difference in weight gain between randomised groups (0-4 weeks Bottle A 0.74 (SD 1.2 SDS versus bottle B 0.51 (0.39, mean difference 0.23 (95% CI -0.31 to 0.77. Secondary outcomes Infants using bottle A had significantly less reported fussing (mean 46 versus 74 minutes/day, p Breast-fed reference group There were no significant differences in primary or secondary outcomes between breast-fed and formula fed infants. The likelyhood of breastfeeding at 3 months was not significantly different in infants subsequently randomised to bottle A or B. Conclusion Bottle design may have short-term effects on infant behaviour which merit further investigation. No significant effects were seen on milk intake or growth; confidence in these findings is limited by the small sample size and this needs confirmation in a larger study. Trial registration Clinical Trials.gov NCT00325208.

  3. Does antenatal pelvic floor muscle training affect the outcome of labour? A randomised controlled trial.

    Science.gov (United States)

    Agur, Wael; Steggles, Pippin; Waterfield, Malcolm; Freeman, Robert

    2008-01-01

    It is thought that antenatal pelvic floor muscle training (PFMT) might produce a strong pelvic floor resulting in prolonged labour, whilst some believe it produces well-controlled muscles that facilitate rotation of the foetal head and shortens the duration of labour. This secondary analysis (of a previously published randomised controlled trial) assesses the labour and delivery details of 268 primigravidae who were originally randomised at approximately 20 weeks gestation to supervised PFMT or a control group. Between the two groups, there was no difference in the duration of the second stage of labour or in the need for instrumental delivery. PFMT does not appear to facilitate or obstruct labour.

  4. Randomised clinical trial of Levonantradol and Chlorpromazine in the prevention of radiotherapy-induced vomiting

    Energy Technology Data Exchange (ETDEWEB)

    Lucraft, H.H.; Palmer, M.K. (Christie Hospital and Holt Radium Inst., Manchester (UK))

    1982-11-01

    Levonantradol is a cannabis derivative. Cannabinoid anti-emetics are being assessed in cancer chemotherapy but have been little used in radiotherapy to date. A pilot study and randomised trial compared the anti-emetic effect of a standard drug (Chlorpromazine 25 mg) with Levonantradol at two doses (0.5 and 0.75 mg) in patients receiving palliative single fraction radiotherapy to sites likely to cause nausea and vomiting. Most patients were out-patients. Both drugs were well tolerated. The frequency of vomiting was similar in all three groups in both the pilot study and randomised trial.

  5. Stress debriefing after childbirth: a randomised controlled trial.

    Science.gov (United States)

    Priest, Susan R; Henderson, Jenni; Evans, Sharon F; Hagan, Ronald

    2003-06-02

    To test whether critical incident stress debriefing after childbirth reduces the incidence of postnatal psychological disorders. Randomised single-blind controlled trial stratified for parity and delivery mode. Two large maternity hospitals in Perth. 1745 women who delivered healthy term infants between April 1996 and December 1997 (875 allocated to intervention and 870 to control group). An individual, standardised debriefing session based on the principles of critical incident stress debriefing carried out within 72 hours of delivery. Diagnosis of stress disorders or depression in the 12 months postpartum, using structured psychological interview and criteria of the Diagnostic and statistical manual of mental disorders, 4th edition. Follow-up information was available for 1730 women (99.1%), 482 of whom underwent psychological interview. There were no significant differences between control and intervention groups in scores on Impact of Events or Edinburgh Postnatal Depression Scales at 2, 6 or 12 months postpartum, or in proportions of women who met diagnostic criteria for a stress disorder (intervention, 0.6% v control, 0.8%; P = 0.58) or major or minor depression (intervention, 17.8% v control, 18.2%; relative risk [95% CI], 0.99 [0.87-1.11]) during the postpartum year. Nor were there differences in median time to onset of depression (intervention, 6 [interquartile range, 4-9] weeks v control, 4 [3-8] weeks; P = 0.84), or duration of depression (intervention, 24 [12-46] weeks v control, 22 [10-52] weeks; P = 0.98). There is a high prevalence of depression in women during the first year after childbirth. A session of midwife-led, critical incident stress debriefing was not effective in preventing postnatal psychological disorders, but had no adverse effects.

  6. Chinese Obstetrics & Gynecology journal club: a randomised controlled trial.

    Science.gov (United States)

    Tsui, Ilene K; Dodson, William C; Kunselman, Allen R; Kuang, Hongying; Han, Feng-Juan; Legro, Richard S; Wu, Xiao-Ke

    2016-01-28

    To assess whether a journal club model could improve comprehension and written and spoken medical English in a population of Chinese medical professionals. The study population consisted of 52 medical professionals who were residents or postgraduate master or PhD students in the Department of Obstetrics and Gynecology, Heilongjiang University of Chinese Medicine, China. After a three-part baseline examination to assess medical English comprehension, participants were randomised to either (1) an intensive journal club treatment arm or (2) a self-study group. At the conclusion of the 8-week intervention participants (n=52) were re-tested with new questions. The primary outcome was the change in score on a multiple choice examination. Secondary outcomes included change in scores on written and oral examinations which were modelled on the Test of English as a Foreign Language (TOEFL). Both groups had improved scores on the multiple choice examination without a statistically significant difference between them (90% power). However, there was a statistically significant difference between the groups in mean improvement in scores for both written (95% CI 1.1 to 5.0; p=0.003) and spoken English (95% CI 0.06 to 3.7; p=0.04) favouring the journal club intervention. Interacting with colleagues and an English-speaking facilitator in a journal club improved both written and spoken medical English in Chinese medical professionals. Journal clubs may be suitable for use as a self-sustainable teaching model to improve fluency in medical English in foreign medical professionals. NCT01844609. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  7. Acupuncture for dry eye: a randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Kim Ae-Ran

    2009-12-01

    Full Text Available Abstract Background Dry eye is usually managed by conventional medical interventions such as artificial tears, anti-inflammatory drugs and surgical treatment. However, since dry eye is one of the most frequent ophthalmologic disorders, safer and more effective methods for its treatment are necessary, especially for vulnerable patients. Acupuncture has been widely used to treat patients with dry eye. Our aim is to evaluate the effectiveness and safety of acupuncture for this condition. Methods/Design A randomised, patient-assessor blinded, sham (non-acupuncture point, shallow acupuncture controlled study was established. Participants allocated to verum acupuncture and sham acupuncture groups will be treated three times weekly for three weeks for a total of nine sessions per participant. Seventeen points (GV23; bilateral BL2, GB4, TE23, Ex1 (Taiyang, ST1 and GB20; and left SP3, LU9, LU10 and HT8 for men, right for women have been selected for the verum acupuncture; for the sham acupuncture, points have been selected that do not coincide with a classical acupuncture point and that are located close to the verum points, except in the case of the rim of the eye. Ocular surface disease index, tear film breakup time, the Schirmer I test, medication quantification scale and general assessment of improvement will be used as outcome variables for evaluating the effectiveness of acupuncture. Safety will also be assessed at every visit. Primary and secondary outcomes will be assessed four weeks after screening. All statistical analyses will be performed using analysis of covariance. Discussion The results of this trial will be used as a basis for clarifying the efficacy of acupuncture for dry eye. Trial registration ClinicalTrials.gov NCT00969280.

  8. Promoting childbirth companions in South Africa: a randomised pilot study

    Directory of Open Access Journals (Sweden)

    Smith Helen

    2007-04-01

    Full Text Available Abstract Background Most women delivering in South African State Maternity Hospitals do not have a childbirth companion; in addition, the quality of care could be better, and at times women are treated inhumanely. We piloted a multi-faceted intervention to encourage uptake of childbirth companions in state hospitals, and hypothesised that lay carers would improve the behaviour of health professionals. Methods We conducted a pilot randomised controlled trial of an intervention to promote childbirth companions in hospital deliveries. We promoted evidence-based information for maternity staff at 10 hospitals through access to the World Health Organization Reproductive Health Library (RHL, computer hardware and training to all ten hospitals. We surveyed 200 women at each site, measuring companionship, and indicators of good obstetric practice and humanity of care. Five hospitals were then randomly allocated to receive an educational intervention to promote childbirth companions, and we surveyed all hospitals again at eight months through a repeat survey of postnatal women. Changes in median values between intervention and control hospitals were examined. Results At baseline, the majority of hospitals did not allow a companion, or access to food or fluids. A third of women were given an episiotomy. Some women were shouted at (17.7%, N = 2085, and a few reported being slapped or struck (4.3%, N = 2080. Despite an initial positive response from staff to the childbirth companion intervention, we detected no difference between intervention and control hospitals in relation to whether a companion was allowed by nursing staff, good obstetric practice or humanity of care. Conclusion The quality and humanity of care in these state hospitals needs to improve. Introducing childbirth companions was more difficult than we anticipated, particularly in under-resourced health care systems with frequent staff changes. We were unable to determine whether the presence

  9. Inflammatory markers in a randomised soya intervention among men.

    Science.gov (United States)

    Maskarinec, Gertraud; Oum, Robert; Chaptman, Ann K; Ognjanovic, Simona

    2009-06-01

    The present analysis investigated the effect of soya foods on serum levels of six inflammatory markers, leptin, adiponectin, monocyte attractant protein 1 (MCP-1), macrophage inflammatory protein-1b (MIP-1b), IL-6 and C-reactive protein (CRP), and their relationship with BMI and lifetime soya intake. We randomised twenty-four men to a high- (two daily servings with 30-35 mg isoflavones per serving) or a low-soya diet for 3 months. After a 1-month washout period, the men crossed over to the other treatment. We used a multiplex bead immunoassay to measure leptin, adiponectin, MCP-1 and MIP-1b and ELISA assays for IL-6 and CRP. The statistical analysis applied mixed models that incorporated the four repeated measurements. The men had a mean age of 58.7 (sd 7.2) years and a mean BMI of 28.4 (sd 4.9) kg/m2. We observed no significant intervention effect of the soya treatment on any of the six markers. After adjustment for age and ethnicity, highly significant associations of BMI and body weight with leptin and MCP-1 emerged. Men with high soya intake early in life also had higher levels of leptin and MCP-1, whereas no association was seen for soya intake during adulthood. MIP-1b, adiponectin, IL-6 and CRP were not related to BMI, body weight or soya intake at any time in life. No intervention effect of soya foods on markers of inflammation was observed in this small study, but adiposity and early-life soya intake were related to higher leptin and MCP-1 levels.

  10. Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial.

    Science.gov (United States)

    Hopewell, Sally; Boutron, Isabelle; Altman, Douglas G; Barbour, Ginny; Moher, David; Montori, Victor; Schriger, David; Cook, Jonathan; Gerry, Stephen; Omar, Omar; Dutton, Peter; Roberts, Corran; Frangou, Eleni; Clifton, Lei; Chiocchia, Virginia; Rombach, Ines; Wartolowska, Karolina; Ravaud, Philippe

    2016-11-28

    The CONSORT Statement is an evidence-informed guideline for reporting randomised controlled trials. A number of extensions have been developed that specify additional information to report for more complex trials. The aim of this study was to evaluate the impact of using a simple web-based tool (WebCONSORT, which incorporates a number of different CONSORT extensions) on the completeness of reporting of randomised trials published in biomedical publications. We conducted a parallel group randomised trial. Journals which endorsed the CONSORT Statement (i.e. referred to it in the Instruction to Authors) but do not actively implement it (i.e. require authors to submit a completed CONSORT checklist) were invited to participate. Authors of randomised trials were requested by the editor to use the web-based tool at the manuscript revision stage. Authors registering to use the tool were randomised (centralised computer generated) to WebCONSORT or control. In the WebCONSORT group, they had access to a tool allowing them to combine the different CONSORT extensions relevant to their trial and generate a customised checklist and flow diagram that they must submit to the editor. In the control group, authors had only access to a CONSORT flow diagram generator. Authors, journal editors, and outcome assessors were blinded to the allocation. The primary outcome was the proportion of CONSORT items (main and extensions) reported in each article post revision. A total of 46 journals actively recruited authors into the trial (25 March 2013 to 22 September 2015); 324 author manuscripts were randomised (WebCONSORT n = 166; control n = 158), of which 197 were reports of randomised trials (n = 94; n = 103). Over a third (39%; n = 127) of registered manuscripts were excluded from the analysis, mainly because the reported study was not a randomised trial. Of those included in the analysis, the most common CONSORT extensions selected were non-pharmacologic (n = 43; n

  11. Statistical analyses in Swedish randomised trials on mammography screening and in other randomised trials on cancer screening: a systematic review

    Science.gov (United States)

    Boniol, Mathieu; Smans, Michel; Sullivan, Richard; Boyle, Peter

    2015-01-01

    Objectives We compared calculations of relative risks of cancer death in Swedish mammography trials and in other cancer screening trials. Participants Men and women from 30 to 74 years of age. Setting Randomised trials on cancer screening. Design For each trial, we identified the intervention period, when screening was offered to screening groups and not to control groups, and the post-intervention period, when screening (or absence of screening) was the same in screening and control groups. We then examined which cancer deaths had been used for the computation of relative risk of cancer death. Main outcome measures Relative risk of cancer death. Results In 17 non-breast screening trials, deaths due to cancers diagnosed during the intervention and post-intervention periods were used for relative risk calculations. In the five Swedish trials, relative risk calculations used deaths due to breast cancers found during intervention periods, but deaths due to breast cancer found at first screening of control groups were added to these groups. After reallocation of the added breast cancer deaths to post-intervention periods of control groups, relative risks of 0.86 (0.76; 0.97) were obtained for cancers found during intervention periods and 0.83 (0.71; 0.97) for cancers found during post-intervention periods, indicating constant reduction in the risk of breast cancer death during follow-up, irrespective of screening. Conclusions The use of unconventional statistical methods in Swedish trials has led to overestimation of risk reduction in breast cancer death attributable to mammography screening. The constant risk reduction observed in screening groups was probably due to the trial design that optimised awareness and medical management of women allocated to screening groups. PMID:26152677

  12. Randomised controlled trial of magnetic-resonance pelvimetry in breech presentation at term

    NARCIS (Netherlands)

    van Loon, AJ; Mantingh, A; Serlier, EK; Kroon, G; Mooyaart, EL; Huisjes, HJ

    1997-01-01

    Background Pelvimetry is widely used in women with breech presentation at term to select those for whom planned vaginal delivery is appropriate. However, its clinical value has never been established, We evaluated pelvimetry in a randomised controlled trial. The main outcome measures were the electi

  13. Improved interobserver variation after training of doctors in the Neer system. A randomised trial

    DEFF Research Database (Denmark)

    Brorson, S; Bagger, J; Sylvest, A;

    2002-01-01

    We investigated whether training doctors to classify proximal fractures of the humerus according to the Neer system could improve interobserver agreement. Fourteen doctors were randomised to two training sessions, or to no training, and asked to categorise 42 unselected pairs of plain radiographs...

  14. Association between alcohol and cardiovascular disease : Mendelian randomisation analysis based on individual participant data

    NARCIS (Netherlands)

    Holmes, Michael V.; Dale, Caroline E.; Zuccolo, Luisa; Silverwood, Richard J.; Guo, Yiran; Ye, Zheng; Prieto-Merino, David; Dehghan, Abbas; Trompet, Stella; Wong, Andrew; Cavadino, Alana; Drogan, Dagmar; Padmanabhan, Sandosh; Li, Shanshan; Yesupriya, Ajay; Leusink, Maarten; Sundstrom, Johan; Hubacek, Jaroslav A.; Pikhart, Hynek; Swerdlow, Daniel I.; Panayiotou, Andrie G.; Borinskaya, Svetlana A.; Finan, Chris; Shah, Sonia; Kuchenbaecker, Karoline B.; Shah, Tina; Engmann, Jorgen; Folkersen, Lasse; Eriksson, Per; Ricceri, Fulvio; Melander, Olle; Sacerdote, Carlotta; Gamble, Dale M.; Rayaprolu, Sruti; Ross, Owen A.; McLachlan, Stela; Vikhireva, Olga; Sluijs, Ivonne; Scott, Robert A.; Adamkova, Vera; Flicker, Leon; Van Bockxmeer, Frank M.; Power, Christine; Marques-Vidal, Pedro; Meade, Tom; Marmot, Michael G.; Ferro, Jose M.; Paulos-Pinheiro, Sofia; Humphries, Steve E.; Talmud, Philippa J.; Leach, Irene Mateo; Verweij, Niek; Linneberg, Allan; Skaaby, Tea; Doevendans, Pieter A.; Cramer, Maarten J.; Van Der Harst, Pim; Klungel, Olaf H.; Dowling, Nicole F.; Dominiczak, Anna F.; Kumari, Meena; Nicolaides, Andrew N.; Weikert, Cornelia; Boeing, Heiner; Ebrahim, Shah; Gaunt, Tom R.; Price, Jackie F.; Lannfelt, Lars; Peasey, Anne; Kubinova, Ruzena; Pajak, Andrzej; Malyutina, Sofia; Voevoda, Mikhail I.; Tamosiunas, Abdonas; Maitland-van Der Zee, Anke H.; Norman, Paul E.; Hankey, Graeme J.; Bergmann, Manuela M.; Hofman, Albert; Franco, Oscar H.; Cooper, Jackie; Palmen, Jutta; Spiering, Wilko; De Jong, Pim A.; Kuh, Diana; Hardy, Rebecca; Uitterlinden, Andre G.; Ikram, M. Arfan; Ford, Ian; Hyppönen, Elina; Almeida, Osvaldo P.; Wareham, Nicholas J.; Khaw, Kay Tee; Hamsten, Anders; Husemoen, Lise Lotte N; Tjønneland, Anne; Tolstrup, Janne S.; Rimm, Eric; Beulens, Joline W J; Verschuren, W. M Monique; Onland-Moret, N. Charlotte; Hofker, Marten H.; Wannamethee, S. Goya; Whincup, Peter H.; Morris, Richard; Vicente, Astrid M.; Watkins, Hugh; Farrall, Martin; Jukema, J. Wouter; Meschia, James; Cupples, L. Adrienne; Sharp, Stephen J.; Fornage, Myriam; Kooperberg, Charles; LaCroix, Andrea Z.; Dai, James Y.; Lanktree, Matthew B.; Siscovick, David S.; Jorgenson, Eric; Spring, Bonnie; Coresh, Josef; Li, Yun R.; Buxbaum, Sarah G.; Schreiner, Pamela J.; Ellison, R. Curtis; Tsai, Michael Y.; Patel, Sanjay R.; Redline, Susan; Johnson, Andrew D.; Hoogeveen, Ron C.; Hakonarson, Hakon; Rotter, Jerome I.; Boerwinkle, Eric; De Bakker, Paul I W; Kivimaki, Mika; Asselbergs, Folkert W.; Sattar, Naveed; Lawlor, Debbie A.; Whittaker, John; Smith, George Davey; Mukamal, Kenneth; Psaty, Bruce M.; Wilson, James G.; Lange, Leslie A.; Hamidovic, Ajna; Nordestgaard, Børge G.; Bobak, Martin; Leon, David A.; Langenberg, Claudia; Palmer, Tom M.; Reiner, Alex P.; Keating, Brendan J.; Dudbridge, Frank; Casas, Juan P.

    2014-01-01

    Objective: To use the rs1229984 variant in the alcohol dehydrogenase 1B gene (ADH1B) as an instrument to investigate the causal role of alcohol in cardiovascular disease. Design: Mendelian randomisation meta-analysis of 56 epidemiological studies. Participants: 261 991 individuals of European descen

  15. Association between alcohol and cardiovascular disease : Mendelian randomisation analysis based on individual participant data

    NARCIS (Netherlands)

    Holmes, Michael V.; Dale, Caroline E.; Zuccolo, Luisa; Silverwood, Richard J.; Guo, Yiran; Ye, Zheng; Prieto-Merino, David; Dehghan, Abbas; Trompet, Stella; Wong, Andrew; Cavadino, Alana; Drogan, Dagmar; Padmanabhan, Sandosh; Li, Shanshan; Yesupriya, Ajay; Leusink, Maarten; Sundstrom, Johan; Hubacek, Jaroslav A.; Pikhart, Hynek; Swerdlow, Daniel I.; Panayiotou, Andrie G.; Borinskaya, Svetlana A.; Finan, Chris; Shah, Sonia; Kuchenbaecker, Karoline B.; Shah, Tina; Engmann, Jorgen; Folkersen, Lasse; Eriksson, Per; Ricceri, Fulvio; Melander, Olle; Sacerdote, Carlotta; Gamble, Dale M.; Rayaprolu, Sruti; Ross, Owen A.; McLachlan, Stela; Vikhireva, Olga; Sluijs, Ivonne; Scott, Robert A.; Adamkova, Vera; Flicker, Leon; Van Bockxmeer, Frank M.; Power, Christine; Marques-Vidal, Pedro; Meade, Tom; Marmot, Michael G.; Ferro, Jose M.; Paulos-Pinheiro, Sofia; Humphries, Steve E.; Talmud, Philippa J.; Mateo Leach, Irene; Verweij, Niek; Linneberg, Allan; Skaaby, Tea; Doevendans, Pieter A.; Cramer, Maarten J.; Van der Harst, Pim; Klungel, Olaf H.; Dowling, Nicole F.; Dominiczak, Anna F.; Kumari, Meena; Nicolaides, Andrew N.; Weikert, Cornelia; Boeing, Heiner; Ebrahim, Shah; Gaunt, Tom R.; Price, Jackie F.; Lannfelt, Lars; Peasey, Anne; Kubinova, Ruzena; Pajak, Andrzej; Malyutina, Sofia; Voevoda, Mikhail I.; Tamosiunas, Abdonas; Maitland-van der Zee, Anke H.; Norman, Paul E.; Hankey, Graeme J.; Bergmann, Manuela M.; Hofman, Albert; Franco, Oscar H.; Cooper, Jackie; Palmen, Jutta; Spiering, Wilko; de Jong, Pim A.; Kuh, Diana; Hardy, Rebecca; Uitterlinden, Andre G.; Ikram, M. Arfan; Ford, Ian; Hyppoenen, Elina; Almeida, Osvaldo P.; Wareham, Nicholas J.; Khaw, Kay-Tee; Hamsten, Anders; Husemoen, Lise Lotte N.; Tjonneland, Anne; Tolstrup, Janne S.; Rimm, Eric; Beulens, Joline W. J.; Verschuren, W. M. Monique; Onland-Moret, N. Charlotte; Hofker, Marten H.; Wannamethee, S. Goya; Whincup, Peter H.; Morris, Richard; Vicente, Astrid M.; Watkins, Hugh; Farrall, Martin; Jukema, J. Wouter; Meschia, James; Cupples, L. Adrienne; Sharp, Stephen J.; Fornage, Myriam; Kooperberg, Charles; LaCroix, Andrea Z.; Dai, James Y.; Lanktree, Matthew B.; Siscovick, David S.; Jorgenson, Eric; Spring, Bonnie; Coresh, Josef; Li, Yun R.; Buxbaum, Sarah G.; Schreiner, Pamela J.; Ellison, R. Curtis; Tsai, Michael Y.; Patel, Sanjay R.; Redline, Susan; Johnson, Andrew D.; Hoogeveen, Ron C.; Rotter, Jerome I.; Boerwinkle, Eric; de Bakker, Paul I. W.; Kivimaki, Mika; Asselbergs, Folkert W.; Sattar, Naveed; Lawlor, Debbie A.; Whittaker, John; Smith, George Davey; Mukamal, Kenneth; Psaty, Bruce M.; Wilson, James G.; Lange, Leslie A.; Hamidovic, Ajna; Hingorani, Aroon D.; Nordestgaard, Borge G.; Bobak, Martin; Leon, David A.; Langenberg, Claudia; Palmer, Tom M.; Reiner, Alex P.; Keating, Brendan J.; Dudbridge, Frank; Casas, Juan P.

    2014-01-01

    Objective To use the rs1229984 variant in the alcohol dehydrogenase 1B gene (ADH1B) as an instrument to investigate the causal role of alcohol in cardiovascular disease. Design Mendelian randomisation meta-analysis of 56 epidemiological studies. Participants 261 991 individuals of European descent,

  16. Psychosocial consequences in the Danish randomised controlled lung cancer screening trial (DLCST)

    DEFF Research Database (Denmark)

    F. Rasmussen, Jakob; Siersma, V.; H. Pedersen, J.

    2015-01-01

    on Airway Symptoms, Stigmatisation, Introvert, and Harm of Smoking. Results: 4104 participants were randomised to the DLCST and the COS-LC completion rates for the CT group and the control group were 95.5% and 73.6%, respectively. There was a significant increase in negative psychosocial consequences from...

  17. Vibration therapy reduces CPAP need in a prospective randomised controlled trial

    NARCIS (Netherlands)

    K. Helder MScN (Onno); W.C.J. Hop (Wim); J.B. van Goudoever (Hans)

    2008-01-01

    textabstractBackground: Increased mucus production is a common phenomena following ventilatory support, which might increase morbidity. In order to reduce airway obstruction we tested the effect of vibration therapy on the duration of ventilatory support. Methodology: We conducted a randomised

  18. Timing of insertion of levonorgestrel-releasing intrauterine system : a randomised controlled trial

    NARCIS (Netherlands)

    van der Heijden, Pahh; Geomini, Pmaj; Herman, M C; Veersema, S; Bongers, M Y

    OBJECTIVE: The objective was to assess whether patient-perceived pain during the insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) depends on the timing during the menstrual cycle. DESIGN: A stratified two-armed non-inferiority randomised controlled trial. SETTING: Large

  19. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

    NARCIS (Netherlands)

    O’Cathain, A.; Hoddinott, P.; Lewin, S.; Thomas, K.J.; Young, B.; Adamson, J.; Jansen, J.F.M.; Mills, N.; Moore, G.; Donovan, J.L.

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full t

  20. Induction versus expectant monitoring for intrauterine growth restriction at term : randomised equivalence trial (DIGITAT)

    NARCIS (Netherlands)

    Boers, K. E.; Vijgen, S. M. C.; Bijlenga, D.; van der Post, J. A. M.; Bekedam, D. J.; Kwee, A.; van der Salm, P. C. M.; van Pampus, M. G.; Spaanderman, M. E. A.; de Boer, K.; Duvekot, J. J.; Bremer, H. A.; Hasaart, T. H. M.; Delemarre, F. M. C.; Bloemenkamp, K. W. M.; van Meir, C. A.; Willekes, C.; Wijnen, E. J.; Rijken, M.; le Cessie, S.; Roumen, F. J. M. E.; Thornton, J. G.; van Lith, J. M. M.; Mol, B. W. J.; Scherjon, S. A.

    2010-01-01

    Objective To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term. Design Multicentre randomised equivalence trial (the Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT)). Setting Eight academic and 44 n

  1. Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial.

    NARCIS (Netherlands)

    Verbakel, N.J.; Langelaan, M.; Verheij, T.J.M.; Wagner, C.; Zwart, D.L.M.

    2015-01-01

    Background A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting A three-arm cluster randomised trial was

  2. Prophylactic antibiotic regimens in tumour surgery (PARITY) A PILOT MULTICENTRE RANDOMISED CONTROLLED TRIAL

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; St Yves, H.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, K.; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Chai, Y.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Ghert, M.; Evaniew, N.; McKay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Bil-Jan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; Yves, H. St.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, Kristine; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Tran, N.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Geller, D.; Hoang, B.; Tingling, J.; Solorzano, C.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Puloski, S.; Monument, M.; Carcary, K.; Cameron, C.; Aboulafia, A.; Loo-Mis, M.; Bosley, J.; Bonvegna, R.; Kassa, M.; Damron, T.; Craig, T.; Reale, M.; Goodman, H. J.; Culbertson, M. Deza; Caruso, P.; Garling, E.; Schwab, J.; Fiore, A.; Phukan, R.; Park, C.; Joshi, L.; Aboulafia, A.; Wallace, M.; Flack, J.; Vaughan, K.; Avergas, A.; Brady, M.; Brown, S.; Schadie, N.; Battersby, R.; Weiss, K.; Goodman, M.; Heyl, A.; Yeschke, C. A.; Sumic, P.; Dudgeon, M.; Prosser, R.; Korenoski, C.; DiCaprio, M.; Palmer, B.; Cioppa, E.; Schaeffer, T. M.; Paul, P.; Toreson, J.; Cummings, J.; Schwartz, L.; Zahner, B.; Morris, C.; Laljani, V.; Mesko, N.; Joyce, M.; Lietman, S.; Wustrack, R.; O'Donnell, R.; Stevenson, C.; Carmody, E.; Tyler, W.; McIntyre, A.; Spiguel, A.; Scarborough, M.; Gibbs, C. P.; Steshyn, J.; Nunn, B.; Rosenthal, H.; Haynes, K.; Leddy, L.; Walton, Z.; Doung, Y-C.; Hayden, J.; Velez, R.; Aguirre, M.; Perez, M.; Barrera, S.; Garca Lopez, A.; Grimer, R.; Dunn, K.; Virdee, H.; Rankin, K.; Beckingsale, T.; Gerrand, C.; Campbell, I.; Allen, M.; Khan, S. Alam; Bakshi, S.; Rastogi, S.; Poudel, R.; Kumar, V. Sampath; Rai, A.; Baptista, A. M.; de Camargo, O. P.; Marais, L.; Rodseth, R.; Ferreira, N.; Rajah, C.; Gumede, S.; Gortzak, Y.; Sternheim, A.; Bickels, J.; Kolander, Y.; Lev, S.; Hettwer, W.; Petersen, M. M.; Grum-Schwensen, T.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.; Mahendra, A.; Gupta, S.; Bergovec, M.; Leithner, A.; Funovics, P.; Dijkstra, P. D. S.; Van De Sande, M.; Hoogenstraaten, A.; Leijerzapf, N.; Steadman, P.; Steadman, P.; Boffano, M.; Piana, R.; Marone, S.; Albertini, U.; Boux, E.; Maiello, A.; Repsa, L.; Zile, S.; Aston, W.; Pollock, R.; Cool, P.; Gibbons, M.; Whit-Well, D.; Cosker, T.; Hemingway, J.; Porter, D.; Patton, S.; Navia, J.; Betancur, A. F.; Laitenen, M.; Pakarinen, K.; Nieminen, J.; Yla-Mononen, S.; Rautiainen, S.; Fiorenza, F.

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a

  3. Melatonin for chronic whiplash syndrome with delayed melatonin onset randomised, placebo-controlled trial

    NARCIS (Netherlands)

    Wieringen, S. van; Jansen, T.; Smits, M.G.; Nagtegaal, J.E.; Coenen, A.M.L.

    2001-01-01

    Objective: To assess the influence of melatonin in patients with chronic whiplash syndrome and delayed melatonin onset. Design: Randomised, double-blind, placebo-controlled, parallel-group trial. One-week baseline was followed by a 4-week treatment period with either melatonin or placebo. In the ba

  4. Relationship between obesity and the risk of clinically significant depression: Mendelian randomisation study.

    LENUS (Irish Health Repository)

    Hung, Chi-Fa

    2014-07-01

    Obesity has been shown to be associated with depression and it has been suggested that higher body mass index (BMI) increases the risk of depression and other common mental disorders. However, the causal relationship remains unclear and Mendelian randomisation, a form of instrumental variable analysis, has recently been employed to attempt to resolve this issue.

  5. Exercise therapy for Stress-related mental disorder, a randomised controlled trial in primary care

    NARCIS (Netherlands)

    Quartero, A. Otto; Burger, Huib; Donker, Marieke; de Wit, Niek J.

    2011-01-01

    Background: to investigate whether a structured physical exercise programme (PEP) improves the recovery of general health in patients suffering from Stress-related Mental Disorder (SMD). Method: Study design: randomised open trial in general practice. Patients from two regions in the Netherlands wer

  6. GP-initiated preconception counselling in a randomised controlled trial does not induce anxiety

    NARCIS (Netherlands)

    Jong-Potjer, L.C. de; Elsinga, J.; Cessie, S. le; Pal-de Bruin, K.M. van der; Knuistingh Neven, A.; Buitendijk, S.E.; Assendelft, W.J.J.

    2006-01-01

    Background: Preconception counselling (PCC) can reduce adverse pregnancy outcome by addressing risk factors prior to pregnancy. This study explores whether anxiety is induced in women either by the offer of PCC or by participation with GP-initiated PCC. Methods: Randomised trial of usual care versus

  7. TIPP and Lichtenstein modalities for inguinal hernia repair: a cost minimisation analysis alongside a randomised trial

    NARCIS (Netherlands)

    Koning, G.G.; Adang, E.M.M.; Stalmeier, P.F.M.; Keus, F.; Vriens, P.W.H.E.; Laarhoven, C.J.H.M. van

    2013-01-01

    The transinguinal preperitoneal (TIPP) technique using a soft mesh with a memory ring was developed recently for inguinal hernia repair. To compare TIPP with the Lichtenstein method, a randomised trial was conducted (ISRCTN93798494). The aim of this study was to perform an economic evaluation of the

  8. TIPP and Lichtenstein modalities for inguinal hernia repair : a cost minimisation analysis alongside a randomised trial

    NARCIS (Netherlands)

    Koning, G. G.; Adang, E. M. M.; Stalmeier, P. F. M.; Keus, F.; Vriens, P. W. H. E.; van Laarhoven, C. J. H. M.

    2013-01-01

    The transinguinal preperitoneal (TIPP) technique using a soft mesh with a memory ring was developed recently for inguinal hernia repair. To compare TIPP with the Lichtenstein method, a randomised trial was conducted (ISRCTN93798494). The aim of this study was to perform an economic evaluation of the

  9. Prophylactic antibiotic regimens in tumour surgery (PARITY) A PILOT MULTICENTRE RANDOMISED CONTROLLED TRIAL

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; St Yves, H.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, K.; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Chai, Y.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Ghert, M.; Evaniew, N.; McKay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Bil-Jan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; Yves, H. St.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, Kristine; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Tran, N.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Geller, D.; Hoang, B.; Tingling, J.; Solorzano, C.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Puloski, S.; Monument, M.; Carcary, K.; Cameron, C.; Aboulafia, A.; Loo-Mis, M.; Bosley, J.; Bonvegna, R.; Kassa, M.; Damron, T.; Craig, T.; Reale, M.; Goodman, H. J.; Culbertson, M. Deza; Caruso, P.; Garling, E.; Schwab, J.; Fiore, A.; Phukan, R.; Park, C.; Joshi, L.; Aboulafia, A.; Wallace, M.; Flack, J.; Vaughan, K.; Avergas, A.; Brady, M.; Brown, S.; Schadie, N.; Battersby, R.; Weiss, K.; Goodman, M.; Heyl, A.; Yeschke, C. A.; Sumic, P.; Dudgeon, M.; Prosser, R.; Korenoski, C.; DiCaprio, M.; Palmer, B.; Cioppa, E.; Schaeffer, T. M.; Paul, P.; Toreson, J.; Cummings, J.; Schwartz, L.; Zahner, B.; Morris, C.; Laljani, V.; Mesko, N.; Joyce, M.; Lietman, S.; Wustrack, R.; O'Donnell, R.; Stevenson, C.; Carmody, E.; Tyler, W.; McIntyre, A.; Spiguel, A.; Scarborough, M.; Gibbs, C. P.; Steshyn, J.; Nunn, B.; Rosenthal, H.; Haynes, K.; Leddy, L.; Walton, Z.; Doung, Y-C.; Hayden, J.; Velez, R.; Aguirre, M.; Perez, M.; Barrera, S.; Garca Lopez, A.; Grimer, R.; Dunn, K.; Virdee, H.; Rankin, K.; Beckingsale, T.; Gerrand, C.; Campbell, I.; Allen, M.; Khan, S. Alam; Bakshi, S.; Rastogi, S.; Poudel, R.; Kumar, V. Sampath; Rai, A.; Baptista, A. M.; de Camargo, O. P.; Marais, L.; Rodseth, R.; Ferreira, N.; Rajah, C.; Gumede, S.; Gortzak, Y.; Sternheim, A.; Bickels, J.; Kolander, Y.; Lev, S.; Hettwer, W.; Petersen, M. M.; Grum-Schwensen, T.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.; Mahendra, A.; Gupta, S.; Bergovec, M.; Leithner, A.; Funovics, P.; Dijkstra, P. D. S.; Van De Sande, M.; Hoogenstraaten, A.; Leijerzapf, N.; Steadman, P.; Steadman, P.; Boffano, M.; Piana, R.; Marone, S.; Albertini, U.; Boux, E.; Maiello, A.; Repsa, L.; Zile, S.; Aston, W.; Pollock, R.; Cool, P.; Gibbons, M.; Whit-Well, D.; Cosker, T.; Hemingway, J.; Porter, D.; Patton, S.; Navia, J.; Betancur, A. F.; Laitenen, M.; Pakarinen, K.; Nieminen, J.; Yla-Mononen, S.; Rautiainen, S.; Fiorenza, F.

    2015-01-01

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a five-da

  10. Conductive Education as a Method of Stroke Rehabilitation: A Single Blinded Randomised Controlled Feasibility Study

    Directory of Open Access Journals (Sweden)

    Judith Bek

    2016-01-01

    Full Text Available Background. Conductive Education for stroke survivors has shown promise but randomised evidence is unavailable. This study assessed the feasibility of a definitive randomised controlled trial to evaluate efficacy. Methods. Adult stroke survivors were recruited through local community notices. Those completing the baseline assessment were randomised using an online program and group allocation was independent. Intervention group participants received 10 weekly 1.5-hour sessions of Conductive Education at the National Institute of Conductive Education in Birmingham, UK. The control group participants attended two group meetings. The study evaluated the feasibility of recruitment procedures, delivery of the intervention, retention of participants, and appropriateness of outcome measures and data collection methods. Independent assessments included the Barthel Index, the Stroke Impact Scale, the Timed Up and Go test, and the Hospital Anxiety and Depression Scale. Results. Eighty-two patients were enrolled; 77 completed the baseline assessment (46 men, mean age 62.1 yrs. and were randomised. 70 commenced the intervention (n=37 or an equivalent waiting period (n=33. 32/37 completed the 10-week training and 32/33 the waiting period. There were no missing items from completed questionnaires and no adverse events. Discussion. Recruitment, intervention, and assessment methods worked well. Transport issues for intervention and assessment appointments require review. Conclusion. A definitive trial is feasible. This trial is registered with ISRCTN84064492.

  11. Stress in Fathers of Moderately and Late Preterm Infants: A Randomised Controlled Trial

    Science.gov (United States)

    Ravn, Ingrid Helen; Lindemann, Rolf; Smeby, Nina Aarhus; Bunch, Eli Haugen; Sandvik, Leiv; Smith, Lars

    2012-01-01

    The atypical behaviour of preterm infants can elicit stress in fathers and influence their ability to perceive and interpret infants' cues. This study investigated whether fathers of moderately and late preterm infants were more stressed than fathers of term infants. In a randomised controlled trial, we also studied the effect of the Mother-Infant…

  12. Comparison of Bobath based and movement science based treatment for stroke: a randomised controlled trial

    OpenAIRE

    van Vliet, P. M.; Lincoln, N; Foxall, A

    2005-01-01

    Objectives: Bobath based (BB) and movement science based (MSB) physiotherapy interventions are widely used for patients after stroke. There is little evidence to suggest which is most effective. This single-blind randomised controlled trial evaluated the effect of these treatments on movement abilities and functional independence.

  13. HLM in Cluster-Randomised Trials--Measuring Efficacy across Diverse Populations of Learners

    Science.gov (United States)

    Hegedus, Stephen; Tapper, John; Dalton, Sara; Sloane, Finbarr

    2013-01-01

    We describe the application of Hierarchical Linear Modelling (HLM) in a cluster-randomised study to examine learning algebraic concepts and procedures in an innovative, technology-rich environment in the US. HLM is applied to measure the impact of such treatment on learning and on contextual variables. We provide a detailed description of such…

  14. Targeting cancer patients' quality of life through social comparison : A randomised trial

    NARCIS (Netherlands)

    Brakel, Thecla M.; Dijkstra, Arie; Buunk, Abraham P.

    2014-01-01

    Objective: Former cancer patients' quality of life can be improved by offering social comparison information. Whether patients, however, benefit from the information may depend on how negative they perceive their present and their future. Design: We conducted a randomised experimental field study wi

  15. Hysteroscopy before in-vitro fertilisation (inSIGHT) : A multicentre, randomised controlled trial

    NARCIS (Netherlands)

    Smit, Janine G.; Kasius, Jenneke C.; Eijkemans, Marinus J C; Koks, Carolien A M; van Golde, Ronald; Nap, Annemiek W.; Scheffer, Gabrielle J.; Manger, Petra A P; Hoek, Annemieke; Schoot, Benedictus C.; van Heusden, Arne M.; Kuchenbecker, Walter K H; Perquin, Denise A M; Fleischer, Kathrin; Kaaijk, Eugenie M.; Sluijmer, Alexander; Friederich, Jaap; Dykgraaf, Ramon H M; van Hooff, Marcel; Louwe, Leonie A.; Kwee, Janet; de Koning, Corry H.; Janssen, Ineke C A H; Mol, Femke; Mol, Ben W J; Broekmans, Frank J M; Torrance, Helen L.

    2016-01-01

    BACKGROUND: Hysteroscopy is often done in infertile women starting in-vitro fertilisation (IVF) to improve their chance of having a baby. However, no data are available from randomised controlled trials to support this practice. We aimed to assess whether routine hysteroscopy before the first IVF tr

  16. Hysteroscopy before in-vitro fertilisation (inSIGHT) : a multicentre, randomised controlled trial

    NARCIS (Netherlands)

    Smit, Janine G.; Kasius, Jenneke C.; Eijkemans, Marinus J. C.; Koks, Carolien A. M.; van Golde, Ronald; Nap, Annemiek W.; Scheffer, Gabrielle J.; Manger, Petra A. P.; Hoek, Annemieke; Schoot, Benedictus C.; van Heusden, Arne M.; Kuchenbecker, Walter K. H.; Perquin, Denise A. M.; Fleischer, Kathrin; Kaaijk, Eugenie M.; Sluijmer, Alexander; Friederich, Jaap; Dykgraaf, Ramon H. M.; van Hooff, Marcel; Louwe, Leonie A.; Kwee, Janet; de Koning, Corry H.; Janssen, Ineke C. A. H.; Mol, Femke; Mol, Ben W. J.; Broekmans, Frank J. M.; Torrance, Helen L.

    2016-01-01

    Background Hysteroscopy is often done in infertile women starting in-vitro fertilisation (IVF) to improve their chance of having a baby. However, no data are available from randomised controlled trials to support this practice. We aimed to assess whether routine hysteroscopy before the first IVF tre

  17. Skills Training to Avoid Inadvertent Plagiarism: Results from a Randomised Control Study

    Science.gov (United States)

    Newton, Fiona J.; Wright, Jill D.; Newton, Joshua D.

    2014-01-01

    Plagiarism continues to be a concern within academic institutions. The current study utilised a randomised control trial of 137 new entry tertiary students to assess the efficacy of a scalable short training session on paraphrasing, patch writing and plagiarism. The results indicate that the training significantly enhanced students' overall…

  18. Health effects of freshwater bathing among primary school children; Design for a randomised exposure study

    NARCIS (Netherlands)

    Asperen IA van; Medema GJ; Havelaar AH; Borgdorff MW; CIE; MGB

    1997-01-01

    To study the health effects of bathing in freshwaters that meet current water quality standard, large epidemiological studies are needed. A design is presented of a study among primary school children, that aims to evaluate current water quality standard. The study concerns a randomised exposure

  19. Physical Activity and School Performance: Evidence from a Danish Randomised School-Intervention Study

    Science.gov (United States)

    Quinto Romani, A.; Klausen, T. B.

    2017-01-01

    It has been claimed that physical activity has a positive effect on not only health but also on school performance. Using data from a randomised school-intervention study, this paper investigates whether different interventions promoting physical activity affect school performance in primary school children. The results indicate that on average,…

  20. Community based physiotherapeutic exercise in COPD self-management : A randomised controlled trial

    NARCIS (Netherlands)

    Effing, Tanja; Zielhuis, Gerhard; Kerstjens, Huib; van der Valk, Paul; van der Palen, Job

    2011-01-01

    Little is known about effects of community-based physiotherapeutic exercise programmes incorporated in COPD self-management programmes. In a randomised trial, the effect of such a programme (COPE-active) on exercise capacity and various secondary outcomes including daily activity as a marker of beha

  1. The significance of clinical experience on learning outcome from resuscitation training-a randomised controlled study

    DEFF Research Database (Denmark)

    Jensen, Morten Lind; Lippert, Freddy; Hesselfeldt, Rasmus

    2009-01-01

    and retention of learning. Materials and methods: This was a prospective single blinded randomised controlled study of the learning outcome from a standard ALS course on a volunteer sample of the entire cohort of newly graduated doctors from Copenhagen University. The outcome measurement was ALS...... a small but statistically significant impact on the retention of learning, but not on the immediate learning outcome....

  2. Initiation of home mechanical ventilation at home : A randomised controlled trial of efficacy, feasibility and costs

    NARCIS (Netherlands)

    Hazenberg, A; Kerstjens, H A M; Prins, S C L; Vermeulen, K M; Wijkstra, P J

    Introduction: Home mechanical ventilation (HMV) in the Netherlands is normally initiated in hospital, but this is expensive and often a burden for the patient. In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is

  3. Initiation of home mechanical ventilation at home: A randomised controlled trial of efficacy, feasibility and costs

    NARCIS (Netherlands)

    Hazenberg, A.; Kerstjens, H.A.M.; Prins, S.C.L.; Vermeulen, K.M.; Wijkstra, P.J.

    2014-01-01

    Introduction Home mechanical ventilation (HMV) in the Netherlands is normally initiated in hospital, but this is expensive and often a burden for the patient. In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is

  4. A randomised trial of lung sealant versus medical therapy for advanced emphysema

    NARCIS (Netherlands)

    Come, Carolyn E.; Kramer, Mordechai R.; Dransfield, Mark T.; Abu-Hijleh, Muhanned; Berkowitz, David; Bezzi, Michela; Bhatt, Surya P.; Boyd, Michael B.; Cases, Enrique; Chen, Alexander C.; Cooper, Christopher B.; Flandes, Javier; Gildea, Thomas; Gotfried, Mark; Hogarth, D. Kyle; Kolandaivelu, Kumaran; Leeds, William; Liesching, Timothy; Marchetti, Nathaniel; Marquette, Charles; Mularski, Richard A.; Pinto-Plata, Victor M.; Pritchett, Michael A.; Rafeq, Samaan; Rubio, Edmundo R.; Slebos, Dirk-Jan; Stratakos, Grigoris; Sy, Alexander; Tsai, Larry W.; Wahidi, Momen; Walsh, John; Wells, J. Michael; Whitten, Patrick E.; Yusen, Roger; Zulueta, Javier J.; Criner, Gerard J.; Washko, George R.

    Uncontrolled pilot studies demonstrated promising results of endoscopic lung volume reduction using emphysematous lung sealant (ELS) in patients with advanced, upper lobe predominant emphysema. We aimed to evaluate the safety and efficacy of ELS in a randomised controlled setting. Patients were

  5. Moderate alcohol consumption increases insulin sensitivity and ADIPOQ expression in postmenopausal women: A randomised, crossover trial

    NARCIS (Netherlands)

    Joosten, M.M.; Beulens, J.W.J.; Kersten, S.; Hendriks, H.F.J.

    2008-01-01

    Aims/hypothesis: To determine whether 6 weeks of daily, moderate alcohol consumption increases expression of the gene encoding adiponectin (ADIPOQ) and plasma levels of the protein, and improves insulin sensitivity in postmenopausal women. Methods: In a randomised, open-label, crossover trial conduc

  6. Initiation of home mechanical ventilation at home : A randomised controlled trial of efficacy, feasibility and costs

    NARCIS (Netherlands)

    Hazenberg, A; Kerstjens, H A M; Prins, S C L; Vermeulen, K M; Wijkstra, P J

    2014-01-01

    Introduction: Home mechanical ventilation (HMV) in the Netherlands is normally initiated in hospital, but this is expensive and often a burden for the patient. In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is non-in

  7. Delayed cord clamping in South African neonates with expected low birthweight : a randomised controlled trial

    NARCIS (Netherlands)

    Tiemersma, Sybrich; Heistein, Julia; Ruijne, Roos; Lopez, Gustavo; van Lobenstein, Jeroen; van Rheenen, Patrick

    OBJECTIVE: To evaluate safety and haematological effects of delayed cord clamping (DCC) in infants with expected low birthweight born in a resource-poor setting. METHODS: Randomised controlled trial involving pregnant women in early labour ≥18 years with intrapartum symphysal-fundal height ≤32 cm.

  8. Helmet therapy in infants with positional skull deformation: randomised controlled trial

    NARCIS (Netherlands)

    Wijk, R.M. van; Vlimmeren, L.A. van; Groothuis-Oudshoorn, C.G.M.; Ploeg, C.P.B. van der; Ijzerman, M.J.; Boere-Boonekamp, M.M.

    2014-01-01

    Objective To determine the effectiveness of helmet therapy for positional skull deformation compared with the natural course of the condition in infants aged 5-6 months.Design Pragmatic, single blinded, randomised controlled trial (HEADS, HElmet therapy Assessment in Deformed Skulls) nested in a pro

  9. The gait and balance of patients with diabetes can be improved: a randomised controlled trial.

    NARCIS (Netherlands)

    Allet, L.; Armand, S.; Bie, R.A. de; Golay, A.; Monnin, D.; Aminian, K.; Staal, J.B.; Bruin, E.D. de

    2010-01-01

    AIMS/HYPOTHESIS: Gait characteristics and balance are altered in diabetic patients. Little is known about possible treatment strategies. This study evaluates the effect of a specific training programme on gait and balance of diabetic patients. METHODS: This was a randomised controlled trial (n=71) w

  10. Implementing Randomised Control Trials in Open and Distance Learning: A Feasibility Study

    Science.gov (United States)

    Herodotou, Christothea; Heiser, Sarah; Rienties, Bart

    2017-01-01

    Randomised control trials (RCTs) are an evidence-based research approach which has not yet been adopted and widely used in open and distance education to inform educational policy and practice. Despite the challenges entailed in their application, RCTs hold the power to robustly evaluate the effects of educational interventions in distance…

  11. Low quality of reporting adverse drug reactions in paediatric randomised controlled trials

    NARCIS (Netherlands)

    de Vries, Tjalling W; van Roon, Eric N

    2010-01-01

    OBJECTIVE: Randomised controlled trials (RCT) offer an opportunity to learn about frequency and character of adverse drug reactions. To improve the quality of reporting adverse effects, the Consort group published recommendations. The authors studied the application of these recommendations in RCTs

  12. Supervised exercise therapy versus usual care for patellofemoral pain syndrome: an open label randomised controlled trial.

    NARCIS (Netherlands)

    R. van Linschoten (Robbart); M. van Middelkoop (Marienke); M.Y. Berger (Marjolein); E.M. Heintjes (Edith); J.A.N. Verhaar (Jan); S.P. Willemsen (Sten); B.W. Koes (Bart); S.M. Bierma-Zeinstra (Sita)

    2009-01-01

    textabstractOBJECTIVE: To assess the effectiveness of supervised exercise therapy compared with usual care with respect to recovery, pain, and function in patients with patellofemoral pain syndrome. DESIGN: Open label randomised controlled trial. SETTING: General practice and sport physician practic

  13. Vibration therapy reduces CPAP need in a prospective randomised controlled trial

    NARCIS (Netherlands)

    K. Helder MScN (Onno); W.C.J. Hop (Wim); J.B. van Goudoever (Hans)

    2008-01-01

    textabstractBackground: Increased mucus production is a common phenomena following ventilatory support, which might increase morbidity. In order to reduce airway obstruction we tested the effect of vibration therapy on the duration of ventilatory support. Methodology: We conducted a randomised contr

  14. Helmet therapy in infants with positional skull deformation: randomised controlled trial

    NARCIS (Netherlands)

    Wijk, R.M. van; Vlimmeren, L.A. van; Groothuis-Oudshoorn, C.G.; Ploeg, C.P. van der; IJzerman, M.J.; Boere-Boonekamp, M.M.

    2014-01-01

    OBJECTIVE: To determine the effectiveness of helmet therapy for positional skull deformation compared with the natural course of the condition in infants aged 5-6 months. DESIGN: Pragmatic, single blinded, randomised controlled trial (HEADS, HElmet therapy Assessment in Deformed Skulls) nested in a

  15. Helmet therapy in infants with positional skull deformation: randomised controlled trial

    NARCIS (Netherlands)

    Wijk, van Renske M.; Vlimmeren, van Leo A.; Groothuis-Oudshoorn, Catharina G.M.; Ploeg, van der Catharina P.B.; IJzerman, Maarten J.; Boere-Boonekamp, Magda M.

    2014-01-01

    Objective To determine the effectiveness of helmet therapy for positional skull deformation compared with the natural course of the condition in infants aged 5-6 months. Design Pragmatic, single blinded, randomised controlled trial (HEADS, HElmet therapy Assessment in Deformed Skulls) nested in a p

  16. Cervical collar or physiotherapy versus wait and see policy for recent onset cervical radiculopathy: randomised trial.

    NARCIS (Netherlands)

    B. Kuijper (Barbara); J.T. Tans; A. Beelen (Anita); F. Nollet (Frans); M. de Visser (Marianne)

    2009-01-01

    textabstractOBJECTIVE: To evaluate the effectiveness of treatment with collar or physiotherapy compared with a wait and see policy in recent onset cervical radiculopathy. DESIGN: Randomised controlled trial. SETTING: Neurology outpatient clinics in three Dutch hospitals. PARTICIPANTS: 205 patients w

  17. Unilateral pallidotomy in Parkinson's disease : a randomised, single-blind, multicentre trial

    NARCIS (Netherlands)

    de Bie, RMA; de Haan, RJ; Nijssen, PCG; Rutgers, AWF; Beute, GN; Haaxma, R; Schmand, B; Staal, MJ; Speelman, J.D.

    1999-01-01

    Background The results of several cohort studies suggest that patients with advanced Parkinson's disease would benefit from unilateral pallidotomy. We have assessed the efficacy of unilateral pallidotomy in a randomised, single-blind, multicentre trial. Methods We enrolled 37 patients with advanced

  18. Association between alcohol and cardiovascular disease : Mendelian randomisation analysis based on individual participant data

    NARCIS (Netherlands)

    Holmes, Michael V.; Dale, Caroline E.; Zuccolo, Luisa; Silverwood, Richard J.; Guo, Yiran; Ye, Zheng; Prieto-Merino, David; Dehghan, Abbas; Trompet, Stella; Wong, Andrew; Cavadino, Alana; Drogan, Dagmar; Padmanabhan, Sandosh; Li, Shanshan; Yesupriya, Ajay; Leusink, Maarten; Sundstrom, Johan; Hubacek, Jaroslav A.; Pikhart, Hynek; Swerdlow, Daniel I.; Panayiotou, Andrie G.; Borinskaya, Svetlana A.; Finan, Chris; Shah, Sonia; Kuchenbaecker, Karoline B.; Shah, Tina; Engmann, Jorgen; Folkersen, Lasse; Eriksson, Per; Ricceri, Fulvio; Melander, Olle; Sacerdote, Carlotta; Gamble, Dale M.; Rayaprolu, Sruti; Ross, Owen A.; McLachlan, Stela; Vikhireva, Olga; Sluijs, Ivonne; Scott, Robert A.; Adamkova, Vera; Flicker, Leon; Van Bockxmeer, Frank M.; Power, Christine; Marques-Vidal, Pedro; Meade, Tom; Marmot, Michael G.; Ferro, Jose M.; Paulos-Pinheiro, Sofia; Humphries, Steve E.; Talmud, Philippa J.; Mateo Leach, Irene; Verweij, Niek; Linneberg, Allan; Skaaby, Tea; Doevendans, Pieter A.; Cramer, Maarten J.; Van der Harst, Pim; Klungel, Olaf H.; Dowling, Nicole F.; Dominiczak, Anna F.; Kumari, Meena; Nicolaides, Andrew N.; Weikert, Cornelia; Boeing, Heiner; Ebrahim, Shah; Gaunt, Tom R.; Price, Jackie F.; Lannfelt, Lars; Peasey, Anne; Kubinova, Ruzena; Pajak, Andrzej; Malyutina, Sofia; Voevoda, Mikhail I.; Tamosiunas, Abdonas; Maitland-van der Zee, Anke H.; Norman, Paul E.; Hankey, Graeme J.; Bergmann, Manuela M.; Hofman, Albert; Franco, Oscar H.; Cooper, Jackie; Palmen, Jutta; Spiering, Wilko; de Jong, Pim A.; Kuh, Diana; Hardy, Rebecca; Uitterlinden, Andre G.; Ikram, M. Arfan; Ford, Ian; Hyppoenen, Elina; Almeida, Osvaldo P.; Wareham, Nicholas J.; Khaw, Kay-Tee; Hamsten, Anders; Husemoen, Lise Lotte N.; Tjonneland, Anne; Tolstrup, Janne S.; Rimm, Eric; Beulens, Joline W. J.; Verschuren, W. M. Monique; Onland-Moret, N. Charlotte; Hofker, Marten H.; Wannamethee, S. Goya; Whincup, Peter H.; Morris, Richard; Vicente, Astrid M.; Watkins, Hugh; Farrall, Martin; Jukema, J. Wouter; Meschia, James; Cupples, L. Adrienne; Sharp, Stephen J.; Fornage, Myriam; Kooperberg, Charles; LaCroix, Andrea Z.; Dai, James Y.; Lanktree, Matthew B.; Siscovick, David S.; Jorgenson, Eric; Spring, Bonnie; Coresh, Josef; Li, Yun R.; Buxbaum, Sarah G.; Schreiner, Pamela J.; Ellison, R. Curtis; Tsai, Michael Y.; Patel, Sanjay R.; Redline, Susan; Johnson, Andrew D.; Hoogeveen, Ron C.; Rotter, Jerome I.; Boerwinkle, Eric; de Bakker, Paul I. W.; Kivimaki, Mika; Asselbergs, Folkert W.; Sattar, Naveed; Lawlor, Debbie A.; Whittaker, John; Smith, George Davey; Mukamal, Kenneth; Psaty, Bruce M.; Wilson, James G.; Lange, Leslie A.; Hamidovic, Ajna; Hingorani, Aroon D.; Nordestgaard, Borge G.; Bobak, Martin; Leon, David A.; Langenberg, Claudia; Palmer, Tom M.; Reiner, Alex P.; Keating, Brendan J.; Dudbridge, Frank; Casas, Juan P.

    2014-01-01

    Objective To use the rs1229984 variant in the alcohol dehydrogenase 1B gene (ADH1B) as an instrument to investigate the causal role of alcohol in cardiovascular disease. Design Mendelian randomisation meta-analysis of 56 epidemiological studies. Participants 261 991 individuals of European descent,

  19. Blood pressure response to changes in sodium and potassium intake: a metaregression analysis of randomised trials

    NARCIS (Netherlands)

    Geleijnse, J.M.; Kok, F.J.; Grobbee, D.E.

    2003-01-01

    The objective of the study was to assess the blood pressure response to changes in sodium and potassium intake and examine effect modification by age, gender, blood pressure, body weight and habitual sodium and potassium intake. Randomised trials of sodium reduction or potassium supplementation and

  20. Randomised controlled trial of topical kanuka honey for the treatment of rosacea

    NARCIS (Netherlands)

    Braithwaite, Irene; Hunt, Anna; Riley, Judith; Fingleton, James; Kocks, Janwillem; Corin, Andrew; Helm, Colin; Sheahan, Davitt; Tofield, Christopher; Montgomery, Barney; Holliday, Mark; Weatherall, Mark; Beasley, Richard

    2015-01-01

    OBJECTIVE: To investigate the efficacy of topical 90% medical-grade kanuka honey and 10% glycerine (Honevo) as a treatment for rosacea. DESIGN: Randomised controlled trial with blinded assessment of primary outcome variable. SETTING: Outpatient primary healthcare population from 5 New Zealand sites.

  1. Evaluation of benefit to patients of training mental health professionals in suicide guidelines: cluster randomised trial.

    NARCIS (Netherlands)

    Beurs, D.P. de; Groot, M.H. de; Keijser, J. de; Duijn, E. van; Winter, R.F.P. de; Kerkhof, A.J.F.M.

    2015-01-01

    Background: Randomised studies examining the effect on patients of training professionals in adherence to suicide guidelines are scarce. Aims: To assess whether patients benefited from the training of professionals in adherence to suicide guidelines. Method: In total 45 psychiatric departments were

  2. Evaluation of benefit to patients of training mental health professionals in suicide guidelines: cluster randomised trial.

    NARCIS (Netherlands)

    Beurs, D.P. de; Groot, M.H. de; Keijser, J. de; Duijn, E. van; Winter, R.F.P. de; Kerkhof, A.J.F.M.

    2016-01-01

    Background: Randomised studies examining the effect on patients of training professionals in adherence to suicide guidelines are scarce. Aims: To assess whether patients benefited from the training of professionals in adherence to suicide guidelines. Method: In total 45 psychiatric departments were

  3. Skills Training to Avoid Inadvertent Plagiarism: Results from a Randomised Control Study

    Science.gov (United States)

    Newton, Fiona J.; Wright, Jill D.; Newton, Joshua D.

    2014-01-01

    Plagiarism continues to be a concern within academic institutions. The current study utilised a randomised control trial of 137 new entry tertiary students to assess the efficacy of a scalable short training session on paraphrasing, patch writing and plagiarism. The results indicate that the training significantly enhanced students' overall…

  4. Testing the activitystat hypothesis: a randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Gomersall Sjaan

    2012-10-01

    Full Text Available Abstract Background The activitystat hypothesis proposes that when physical activity or energy expenditure is increased or decreased in one domain, there will be a compensatory change in another domain to maintain an overall, stable level of physical activity or energy expenditure. To date, there has been no experimental study primarily designed to test the activitystat hypothesis in adults. The aim of this trial is to determine the effect of two different imposed exercise loads on total daily energy expenditure and physical activity levels. Methods This study will be a randomised, multi-arm, parallel controlled trial. Insufficiently active adults (as determined by the Active Australia survey aged 18–60 years old will be recruited for this study (n=146. Participants must also satisfy the Sports Medicine Australia Pre-Exercise Screening System and must weigh less than 150 kg. Participants will be randomly assigned to one of three groups using a computer-generated allocation sequence. Participants in the Moderate exercise group will receive an additional 150 minutes of moderate to vigorous physical activity per week for six weeks, and those in the Extensive exercise group will receive an additional 300 minutes of moderate to vigorous physical activity per week for six weeks. Exercise targets will be accumulated through both group and individual exercise sessions monitored by heart rate telemetry. Control participants will not be given any instructions regarding lifestyle. The primary outcome measures are activity energy expenditure (doubly labeled water and physical activity (accelerometry. Secondary measures will include resting metabolic rate via indirect calorimetry, use of time, maximal oxygen consumption and several anthropometric and physiological measures. Outcome measures will be conducted at baseline (zero weeks, mid- and end-intervention (three and six weeks with three (12 weeks and six month (24 week follow-up. All assessors will be

  5. Randomised prior feedback modulates neural signals of outcome monitoring.

    Science.gov (United States)

    Mushtaq, Faisal; Wilkie, Richard M; Mon-Williams, Mark A; Schaefer, Alexandre

    2016-01-15

    Substantial evidence indicates that decision outcomes are typically evaluated relative to expectations learned from relatively long sequences of previous outcomes. This mechanism is thought to play a key role in general learning and adaptation processes but relatively little is known about the determinants of outcome evaluation when the capacity to learn from series of prior events is difficult or impossible. To investigate this issue, we examined how the feedback-related negativity (FRN) is modulated by information briefly presented before outcome evaluation. The FRN is a brain potential time-locked to the delivery of decision feedback and it is widely thought to be sensitive to prior expectations. We conducted a multi-trial gambling task in which outcomes at each trial were fully randomised to minimise the capacity to learn from long sequences of prior outcomes. Event-related potentials for outcomes (Win/Loss) in the current trial (Outcomet) were separated according to the type of outcomes that occurred in the preceding two trials (Outcomet-1 and Outcomet-2). We found that FRN voltage was more positive during the processing of win feedback when it was preceded by wins at Outcomet-1 compared to win feedback preceded by losses at Outcomet-1. However, no influence of preceding outcomes was found on FRN activity relative to the processing of loss feedback. We also found no effects of Outcomet-2 on FRN amplitude relative to current feedback. Additional analyses indicated that this effect was largest for trials in which participants selected a decision different to the gamble chosen in the previous trial. These findings are inconsistent with models that solely relate the FRN to prediction error computation. Instead, our results suggest that if stable predictions about future events are weak or non-existent, then outcome processing can be determined by affective systems. More specifically, our results indicate that the FRN is likely to reflect the activity of positive

  6. Probiotics in the prevention of eczema: a randomised controlled trial

    Science.gov (United States)

    Allen, Stephen J; Jordan, Sue; Storey, Melanie; Thornton, Catherine A; Gravenor, Michael B; Garaiova, Iveta; Plummer, Susan F; Wang, Duolao; Morgan, Gareth

    2014-01-01

    Objective To evaluate a multistrain, high-dose probiotic in the prevention of eczema. Design A randomised, double-blind, placebo-controlled, parallel group trial. Settings Antenatal clinics, research clinic, children at home. Patients Pregnant women and their infants. Interventions Women from 36 weeks gestation and their infants to age 6 months received daily either the probiotic (Lactobacillus salivarius CUL61, Lactobacillus paracasei CUL08, Bifidobacterium animalis subspecies lactis CUL34 and Bifidobacterium bifidum CUL20; total of 1010 organisms/day) or matching placebo. Main outcome measure Diagnosed eczema at age 2 years. Infants were followed up by questionnaire. Clinical examination and skin prick tests to common allergens were done at 6 months and 2 years. Results The cumulative frequency of diagnosed eczema at 2 years was similar in the probiotic (73/214, 34.1%) and placebo arms (72/222, 32.4%; OR 1.07, 95% CI 0.72 to 1.6). Among the secondary outcomes, the cumulative frequency of skin prick sensitivity at 2 years was reduced in the probiotic (18/171; 10.5%) compared with the placebo arm (32/173; 18.5%; OR 0.52, 95% CI 0.28 to 0.98). The statistically significant differences between the arms were mainly in sensitisation to cow's milk and hen's egg proteins at 6 months. Atopic eczema occurred in 9/171 (5.3%) children in the probiotic arm and 21/173 (12.1%) in the placebo arm (OR 0.40, 95% CI 0.18 to 0.91). Conclusions The study did not provide evidence that the probiotic either prevented eczema during the study or reduced its severity. However, the probiotic seemed to prevent atopic sensitisation to common food allergens and so reduce the incidence of atopic eczema in early childhood. Trial registration Number ISRCTN26287422. PMID:24947281

  7. Atypical antipsychotics in bipolar disorder: systematic review of randomised trials

    Directory of Open Access Journals (Sweden)

    Moore R Andrew

    2007-08-01

    Full Text Available Abstract Background Atypical antipsychotics are increasingly used for treatment of mental illnesses like schizophrenia and bipolar disorder, and considered to have fewer extrapyramidal effects than older antipsychotics. Methods We examined efficacy in randomised trials of bipolar disorder where the presenting episode was either depression, or manic/mixed, comparing atypical antipsychotic with placebo or active comparator, examined withdrawals for any cause, or due to lack of efficacy or adverse events, and combined all phases for adverse event analysis. Studies were found through systematic search (PubMed, EMBASE, Cochrane Library, and data combined for analysis where there was clinical homogeneity, with especial reference to trial duration. Results In five trials (2,206 patients participants presented with a depressive episode, and in 25 trials (6,174 patients the presenting episode was manic or mixed. In 8-week studies presenting with depression, quetiapine and olanzapine produced significantly better rates of response and symptomatic remission than placebo, with NNTs of 5–6, but more adverse event withdrawals (NNH 12. With mania or mixed presentation atypical antipsychotics produced significantly better rates of response and symptomatic remission than placebo, with NNTs of about 5 up to six weeks, and 4 at 6–12 weeks, but more adverse event withdrawals (NNH of about 22 in studies of 6–12 weeks. In comparisons with established treatments, atypical antipsychotics had similar efficacy, but significantly fewer adverse event withdrawals (NNT to prevent one withdrawal about 10. In maintenance trials atypical antipsychotics had significantly fewer relapses to depression or mania than placebo or active comparator. In placebo-controlled trials, atypical antipsychotics were associated with higher rates of weight gain of ≥7% (mainly olanzapine trials, somnolence, and extrapyramidal symptoms. In active controlled trials, atypical antipsychotics

  8. Timing of birth for women with a twin pregnancy at term: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Haslam Ross R

    2010-10-01

    Full Text Available Abstract Background There is a well recognized risk of complications for both women and infants of a twin pregnancy, increasing beyond 37 weeks gestation. Preterm birth prior to 37 weeks gestation is a recognized complication of a twin pregnancy, however, up to 50% of twins will be born after this time. The aims of this randomised trial are to assess whether elective birth at 37 weeks gestation compared with standard care in women with a twin pregnancy affects the risk of perinatal death, and serious infant complications. Methods/Design Design: Multicentred randomised trial. Inclusion Criteria: women with a twin pregnancy at 366 weeks or more without contraindication to continuation of pregnancy. Trial Entry & Randomisation: Following written informed consent, eligible women will be randomised from 36+6 weeks gestation. The randomisation schedule uses balanced variable blocks, with stratification for centre of birth and planned mode of birth. Women will be randomised to either elective birth or standard care. Treatment Schedules: Women allocated to the elective birth group will be planned for elective birth from 37 weeks gestation. Where the plan is for vaginal birth, this will involve induction of labour. Where the plan is for caesarean birth, this will involve elective caesarean section. For women allocated to standard care, birth will be planned for 38 weeks gestation or later. Where the plan is for vaginal birth, this will involve either awaiting the spontaneous onset of labour, or induction of labour if required. Where the plan is for caesarean birth, this will involve elective caesarean section (after 38 and as close to 39 weeks as possible. Primary Study Outcome: A composite of perinatal mortality or serious neonatal morbidity. Sample Size: 460 women with a twin pregnancy to show a reduction in the composite outcome from 16.3% to 6.7% with adjustment for the clustering of twin infants within mothers (p = 0.05, 80% power. Discussion This

  9. DIRECT trial. Diverticulitis recurrences or continuing symptoms: Operative versus conservative Treatment. A MULTICENTER RANDOMISED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    van de Wall Bryan JM

    2010-08-01

    Full Text Available Abstract Background Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses. Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management. We, therefore, constructed a randomised clinical trial comparing these two treatment strategies. Methods/design The DIRECT trial is a multicenter randomised clinical trial. Patients (18-75 years presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomised. Patients randomised for conservative treatment are treated according to the current daily practice (antibiotics, analgetics and/or expectant management. Patients randomised for elective resection will undergo an elective resection of the affected colon segment. Preferably, a laparoscopic approach is used. The primary outcome is health related quality of life measured by the Gastro-intestinal Quality of Life Index, Short-Form 36, EQ-5D and a visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs. The total follow-up will be three years. Discussion Considering the high incidence and the

  10. Promoting Recruitment using Information Management Efficiently (PRIME): study protocol for a stepped-wedge cluster randomised controlled trial within the REstart or STop Antithrombotics Randomised Trial (RESTART).

    Science.gov (United States)

    Maxwell, Amy E; Dennis, Martin; Rudd, Anthony; Weir, Christopher J; Parker, Richard A; Al-Shahi Salman, Rustam

    2017-03-01

    Research into methods to boost recruitment has been identified as the highest priority for randomised controlled trial (RCT) methodological research in the United Kingdom. Slow recruitment delays the delivery of research and inflates costs. Using electronic patient records has been shown to boost recruitment to ongoing RCTs in primary care by identifying potentially eligible participants, but this approach remains relatively unexplored in secondary care, and for stroke in particular. The REstart or STop Antithrombotics Randomised Trial (RESTART; ISRCTN71907627) is an ongoing RCT of secondary prevention after stroke due to intracerebral haemorrhage. Promoting Recruitment using Information Management Efficiently (PRIME) is a stepped-wedge cluster randomised trial of a complex intervention to help RESTART sites increase their recruitment and attain their own target numbers of participants. Seventy-two hospital sites that were located in England, Wales or Scotland and were active in RESTART in June 2015 opted into PRIME. Sites were randomly allocated (using a computer-generated block randomisation algorithm, stratified by hospital location in Scotland vs. England/Wales) to one of 12 months in which the intervention would be delivered. All sites began in the control state. The intervention was delivered by a recruitment co-ordinator via a teleconference with each site. The intervention involved discussing recruitment strategies, providing software for each site to extract from their own stroke audit data lists of patients who were potentially eligible for RESTART, and a second teleconference to review progress 6 months later. The recruitment co-ordinator was blinded to the timing of the intervention until 2 months before it was due at a site. Staff at RESTART sites were blinded to the nature and timing of the intervention. The primary outcome is the total number of patients randomised into RESTART per month per site and will be analysed in a negative binomial

  11. Increasing participation of cancer patients in randomised controlled trials: a systematic review

    Directory of Open Access Journals (Sweden)

    Stirk Lisa

    2006-05-01

    Full Text Available Abstract Background There are many barriers to patient participation in randomised controlled trials of cancer treatments. To increase participation in trials, strategies need to be identified to overcome these barriers. Our aim was to assess the effectiveness of interventions to overcome barriers to patient participation in randomised controlled trials (RCTs of cancer treatments. Methods A systematic review was conducted. Published and unpublished studies in any language were searched for in fifteen electronic databases, including MEDLINE, EMBASE, CINAHL and PsycINFO, from inception to the end of 2004. Studies of any interventions to improve cancer patient participation in RCTs, which reported the change in recruitment rates, were eligible for inclusion. RCTs and non-randomised controlled trials as well as before and after studies reporting baseline rates specific to the population being investigated were included. Data were extracted by one reviewer into structured summary tables and checked for accuracy by a second reviewer. Each included study was assessed against a checklist for methodological quality by one reviewer and checked by a second reviewer. A narrative synthesis was conducted. Results Eight studies were identified that met the inclusion criteria: three RCTs, two non-randomised controlled trials and three observational studies. Six of the studies had an intervention that had some relevance to the UK. There was no robust evidence that any of the interventions investigated led to an increase in cancer patient participation in RCTs, though one good quality RCT found that urologists and nurses were equally effective at recruiting participants to a treatment trial for prostate cancer. Although there was no evidence of an effect in any of the studies, the evidence was not of sufficient quality to be able to conclude that these interventions therefore do not work. Conclusion There is not a strong evidence-base for interventions that

  12. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study.

    Science.gov (United States)

    Lewin, Simon; Glenton, Claire; Oxman, Andrew D

    2009-09-10

    To examine the use of qualitative approaches alongside randomised trials of complex healthcare interventions. Review of randomised controlled trials of interventions to change professional practice or the organisation of care. Systematic sample of 100 trials published in English from the register of the Cochrane Effective Practice and Organisation of Care Review Group. Published and unpublished qualitative studies linked to the randomised controlled trials were identified through database searches and contact with authors. Data were extracted from each study by two reviewers using a standard form. We extracted data describing the randomised controlled trials and qualitative studies, the quality of these studies, and how, if at all, the qualitative and quantitative findings were combined. A narrative synthesis of the findings was done. 30 of the 100 trials had associated qualitative work and 19 of these were published studies. 14 qualitative studies were done before the trial, nine during the trial, and four after the trial. 13 studies reported an explicit theoretical basis and 11 specified their methodological approach. Approaches to sampling and data analysis were poorly described. For most cases (n=20) we found no indication of integration of qualitative and quantitative findings at the level of either analysis or interpretation. The quality of the qualitative studies was highly variable. Qualitative studies alongside randomised controlled trials remain uncommon, even where relatively complex interventions are being evaluated. Most of the qualitative studies were carried out before or during the trials with few studies used to explain trial results. The findings of the qualitative studies seemed to be poorly integrated with those of the trials and often had major methodological shortcomings.

  13. Changing cluster composition in cluster randomised controlled trials: design and analysis considerations.

    Science.gov (United States)

    Corrigan, Neil; Bankart, Michael J G; Gray, Laura J; Smith, Karen L

    2014-05-24

    There are many methodological challenges in the conduct and analysis of cluster randomised controlled trials, but one that has received little attention is that of post-randomisation changes to cluster composition. To illustrate this, we focus on the issue of cluster merging, considering the impact on the design, analysis and interpretation of trial outcomes. We explored the effects of merging clusters on study power using standard methods of power calculation. We assessed the potential impacts on study findings of both homogeneous cluster merges (involving clusters randomised to the same arm of a trial) and heterogeneous merges (involving clusters randomised to different arms of a trial) by simulation. To determine the impact on bias and precision of treatment effect estimates, we applied standard methods of analysis to different populations under analysis. Cluster merging produced a systematic reduction in study power. This effect depended on the number of merges and was most pronounced when variability in cluster size was at its greatest. Simulations demonstrate that the impact on analysis was minimal when cluster merges were homogeneous, with impact on study power being balanced by a change in observed intracluster correlation coefficient (ICC). We found a decrease in study power when cluster merges were heterogeneous, and the estimate of treatment effect was attenuated. Examples of cluster merges found in previously published reports of cluster randomised trials were typically homogeneous rather than heterogeneous. Simulations demonstrated that trial findings in such cases would be unbiased. However, simulations also showed that any heterogeneous cluster merges would introduce bias that would be hard to quantify, as well as having negative impacts on the precision of estimates obtained. Further methodological development is warranted to better determine how to analyse such trials appropriately. Interim recommendations include avoidance of cluster merges where

  14. Effect of using pump on postoperative pleural effusion in the patients that underwent CABG

    Directory of Open Access Journals (Sweden)

    Mehmet Özülkü

    2015-08-01

    Full Text Available Abstract Objective: The present study investigated effect of using pump on postoperative pleural effusion in patients who underwent coronary artery bypass grafting. Methods: A total of 256 patients who underwent isolated coronary artery bypass grafting surgery in the Cardiovascular Surgery clinic were enrolled in the study. Jostra-Cobe (Model 043213 105, VLC 865, Sweden heart-lung machine was used in on-pump coronary artery bypass grafting. Off-pump coronary artery bypass grafting was performed using Octopus and Starfish. Proximal anastomoses to the aorta in both on-pump and off-pump techniques were performed by side clamps. The patients were discharged from the hospital between postoperative day 6 and day 11. Results: The incidence of postoperative right pleural effusion and bilateral pleural effusion was found to be higher as a count in Group 1 (on-pump as compared to Group 2 (off-pump. But the difference was not statistically significant [P>0.05 for right pleural effusion (P=0.893, P>0.05 for bilateral pleural effusion (P=0.780]. Left pleural effusion was encountered to be lower in Group 2 (off-pump. The difference was found to be statistically significant (P<0.05, P=0.006. Conclusion: Under the light of these results, it can be said that left pleural effusion is less prevalent in the patients that underwent off-pump coronary artery bypass grafting when compared to the patients that underwent on-pump coronary artery bypass grafting.

  15. A community-based cluster randomised trial of safe storage to reduce pesticide self-poisoning in rural Sri Lanka

    DEFF Research Database (Denmark)

    Pearson, Melissa; Konradsen, Flemming; Gunnell, David

    2011-01-01

    partnership between provincial health services, local and international researchers, and local communities. We discuss issues in relation to randomisation and contamination, engaging control villages, the intervention, and strategies to improve adherence. Trial Registritation The trial is registered...

  16. Comparison of physiotherapy, manipulation, and corticosteroid injection for treating shoulder complaints in general practice : Randomised, single blind study

    NARCIS (Netherlands)

    Winters, Jan C.; Sobel, J.S.; Groenier, Klaas H.; Arendzen, J.H.; Meyboom-de Jong, B.

    1997-01-01

    Objective: To compare the efficacy of physiotherapy, manipulation, and corticosteroid injection for treating patients with shoulder complaints in general practice. Design: Randomised, single blind study. Setting: Seven general practices in the Netherlands. Subjects: 198 patients with shoulder compla

  17. Comparison of physiotherapy, manipulation, and corticosteroid injection for treating shoulder complaints in general practice : Randomised, single blind study

    NARCIS (Netherlands)

    Winters, Jan C.; Sobel, J.S.; Groenier, Klaas H.; Arendzen, J.H.; Meyboom-de Jong, B.

    1997-01-01

    Objective: To compare the efficacy of physiotherapy, manipulation, and corticosteroid injection for treating patients with shoulder complaints in general practice. Design: Randomised, single blind study. Setting: Seven general practices in the Netherlands. Subjects: 198 patients with shoulder

  18. Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomised, crossover and open-labelled study

    DEFF Research Database (Denmark)

    Chartier-Kastler, E; Lauge, I; Ruffion, A

    2011-01-01

    Self-catheterising males aged ≥18 years with spinal cord lesion and normal/impaired urethral sensation were enrolled in this comparative, randomised, crossover and open-labelled multicentre trial....

  19. Fusidic acid cream in the treatment of impetigo in general practice: double blind randomised placebo controlled trial

    NARCIS (Netherlands)

    S. Koning (Sander); L.W.A. van Suijlekom-Smit (Lisette); J.L. Nouwen (Jan); C.M. Verduin (Cees); R.M.D. Bernsen (Roos); A.P. Oranje (Arnold); S. Thomas (Siep); J.C. van der Wouden (Hans)

    2002-01-01

    textabstractOBJECTIVE: To test the hypothesis that fusidic acid would not increase the treatment effect of disinfecting with povidone-iodine alone in children with impetigo. DESIGN: Randomised placebo controlled trial. SETTING: General practices in Greater Rotterdam. PARTICIPANTS:

  20. Fusidic acid cream in the treatment of impetigo in general practice: double blind randomised placebo controlled trial

    NARCIS (Netherlands)

    S. Koning (Sander); L.W.A. van Suijlekom-Smit (Lisette); J.L. Nouwen (Jan); C.M. Verduin (Cees); R.M.D. Bernsen (Roos); A.P. Oranje (Arnold); S. Thomas (Siep); J.C. van der Wouden (Hans)

    2002-01-01

    textabstractOBJECTIVE: To test the hypothesis that fusidic acid would not increase the treatment effect of disinfecting with povidone-iodine alone in children with impetigo. DESIGN: Randomised placebo controlled trial. SETTING: General practices in Greater Rotterdam. PARTICIPANTS:

  1. Conservative treatment in patients with an acute lumbosacral radicular syndrome: design of a randomised clinical trial [ISRCTN68857256].

    NARCIS (Netherlands)

    P.A.J. Luijsterburg (Pim); A.P. Verhagen (Arianne); R.W.J.G. Ostelo (Raymond); H.J. van den Hoogen (Hans); W.C. Peul (Wilco); C.J.J. Avezaat (Cees); B.W. Koes (Bart)

    2004-01-01

    textabstractBACKGROUND: The objective is to present the design of randomised clinical trial (RCT) on the effectiveness of physical therapy added to general practitioners management compared to general practitioners management only in patients with an acute lumbosacral radicular syn

  2. Randomised placebo controlled multicentre trial to assess short term clarithromycin for patients with stable coronary heart disease: CLARICOR trial

    DEFF Research Database (Denmark)

    Jespersen, Christian M; Als-Nielsen, Bodil; Damgaard, Morten

    2005-01-01

    OBJECTIVE: To determine if the macrolide clarithromycin affects mortality and cardiovascular morbidity in patients with stable coronary heart disease. DESIGN: Centrally randomised multicentre trial. All parties at all stages were blinded. Analyses were by intention to treat. SETTING: Five Copenha...

  3. [Probiotic prophylaxis in patients with predicted severe acute pancreatitis: a randomised, double-blind, placebo-controlled trial

    NARCIS (Netherlands)

    Besselink, M.G.; Santvoort, H.C. van; Buskens, E.; Boermeester, M.A.; Goor, H. van; Timmerman, H.M.; Nieuwenhuijs, V.B.; Bollen, T.L.; Ramshorst, B. van; Witteman, B.J.M.; Rosman, C.; Ploeg, R.J.; Brink, M.; Schaapherder, A.F.; Dejong, C.H.; Wahab, P.J.; Laarhoven, C.J.H.M. van; Harst, E. van der; Eijck, C.H. van; Cuesta, M.A.; Akkermans, L.M.; Gooszen, H.G.

    2008-01-01

    OBJECTIVE: To evaluate whether enteral prophylaxis with probiotics in patients with predicted severe acute pancreatitis prevents infectious complications. DESIGN: Multicentre, randomised, double-blind, placebo-controlled trial. METHOD: A total of 296 patients with predicted severe acute pancreatitis

  4. Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial

    National Research Council Canada - National Science Library

    Garg, Amit X; Vincent, Jessica; Cuerden, Meaghan; Parikh, Chirag; Devereaux, P J; Teoh, Kevin; Yusuf, Salim; Hildebrand, Ainslie; Lamy, Andre; Zuo, Yunxia; Sessler, Daniel I; Shah, Pallav; Abbasi, Seyed Hesameddin; Quantz, Mackenzie; Yared, Jean-Pierre; Noiseux, Nicolas; Tagarakis, Georgios; Rochon, Antoine; Pogue, Janice; Walsh, Michael; Chan, Matthew T V; Lamontagne, Francois; Salehiomran, Abbas; Whitlock, Richard

    2014-01-01

    Steroids In caRdiac Surgery trial (SIRS) is a large international randomised controlled trial of methylprednisolone or placebo in patients undergoing cardiac surgery with the use of a cardiopulmonary bypass pump...

  5. A randomised pilot study to assess the efficacy of an interactive, multimedia tool of cognitive stimulation in Alzheimer's disease

    National Research Council Canada - National Science Library

    Tárraga, L; Boada, M; Modinos, G; Espinosa, A; Diego, S; Morera, A; Guitart, M; Balcells, J; López, O L; Becker, J T

    2006-01-01

    .... This is a 24-week, single-blind, randomised pilot study conducted on 46 mildly impaired patients suspected of having Alzheimer's disease receiving stable treatment with cholinesterase inhibitors (ChEIs...

  6. Randomised double blind placebo controlled trial of prednisolone in children admitted to hospital with respiratory syncytial virus bronchiolitis

    NARCIS (Netherlands)

    van Woensel, JBM; Wolfs, TFW; vanAalderen, WMC; Brand, PLP; Kimpen, JLL

    Background - Experimental and clinical evidence suggests that respiratory syncytial virus (RSV) bronchiolitis is an immune mediated disease. Corticosteroids might therefore be effective in the treatment of RSV bronchiolitis. Methods - A randomised double blind trial was conducted in children up to

  7. No identifiable Hb1Ac or lifestyle change after a comprehensive diabetes programme including motivational interviewing: A cluster randomised trial

    NARCIS (Netherlands)

    Jansink, R.M.E.; Braspenning, J.C.C.; Keizer, E.; Weijden, T. van der; Elwyn, G.; Grol, R.P.T.M.

    2013-01-01

    Abstract Objective. To study the effectiveness of a comprehensive diabetes programme in general practice that integrates patient-centred lifestyle counselling into structured diabetes care. Design and setting. Cluster randomised trial in general practices. Intervention. Nurse-led structured diabetes

  8. Postpartum perineal reapir performed by midwives: A randomised trial comparing two suture techniques for perineal repair leaving the skin unsutured

    DEFF Research Database (Denmark)

    Kindberg, Sara; Misan, Stehouwer; Hvidman, Lone

    2008-01-01

    and episiotomies.   Design          A double blind randomised controlled trial.   Setting          A Danish university hospital with more than 4800 deliveries annually.   Population   400 healthy primiparous women with a vaginal delivery at term.   Method         Randomisation was computer-controlled. Structured...

  9. A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: Trial protocol

    OpenAIRE

    Cox, Helen; Tilbrook, Helen; Aplin, John; Chuang, Ling-Hsiang; Hewitt, Catherine; Jayakody, Shalmini; Semlyen, Anna; Soares, Marta O; Torgerson, David; Trewhela, Alison; Watt, Ian; Worthy, Gill

    2010-01-01

    A systematic review revealed three small randomised controlled trials of yoga for low back pain, all of which showed effects on back pain that favoured the yoga group. To build on these studies a larger trial, with longer term follow-up, and a number of different yoga teachers delivering the intervention is required. This study protocol describes the details of a randomised controlled trial (RCT) to determine the effectiveness and cost-effectiveness of Yoga for chronic Low Back Pain, which is...

  10. A low cost virtual reality system for home based rehabilitation of the arm following stroke: A randomised controlled feasibility trial

    OpenAIRE

    Standen, P.; Threapleton, K; Richardson, A; Connell, L; Brown, D.; Battersby, S; Platts, F; Burton, A

    2016-01-01

    Objective: To assess the feasibility of conducting a randomised controlled trial of a home-based virtual reality system for rehabilitation of the arm following stroke. Design: Two group feasibility randomised controlled trial of intervention versus usual care. Setting: Patients’ homes. Participants: Patients aged 18 or over, with residual arm dysfunction following stroke and, no longer receiving any other intensive rehabilitation. Interventions: Eight weeks’ use of a low cost home-based virtu...

  11. Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain

    OpenAIRE

    Little, Paul; Lewith, George; Webley, Fran; Evans, Maggie; Beattie, Angela; Middleton, Karen; Barnett, Jane; Ballard, Kathleen; Oxford, Frances; Smith, Peter; Yardley, Lucy; Hollinghurst, Sandra; Sharp, Debbie

    2008-01-01

    Objective To determine the effectiveness of lessons in the Alexander technique, massage therapy, and advice from a doctor to take exercise (exercise prescription) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain. Design Factorial randomised trial. Setting 64 general practices in England. Participants 579 patients with chronic or recurrent low back pain; 144 were randomised to normal care, 147 to massage, 144 to six Alexander technique lessons...

  12. Behavioural activation versus mindfulness-based guided self-help treatment administered through a smartphone application: a randomised controlled trial

    OpenAIRE

    Ly, Kien Hoa; Trüschel, Anna; Jarl, Linnea; Magnusson, Susanna; Windahl, Tove; Johansson, Robert; Carlbring, Per; Andersson, Gerhard

    2014-01-01

    OBJECTIVES: Evaluating and comparing the effectiveness of two smartphone-delivered treatments: one based on behavioural activation (BA) and other on mindfulness. DESIGN: Parallel randomised controlled, open, trial. Participants were allocated using an online randomisation tool, handled by an independent person who was separate from the staff conducting the study. SETTING: General community, with recruitment nationally through mass media and advertisements. PARTICIPANTS: 40 participants diagno...

  13. The haemodynamic effects of the perioperative terlipressin infusion in living donor liver transplantation: A randomised controlled study

    OpenAIRE

    Nagwa Ibrahim; Ashraf Hasanin; Sabry Abd Allah; Eman Sayed; Mohamed Afifi; Khaled Yassen; Wesam Saber; Magdy Khalil

    2015-01-01

    Background and Aims: Liver disease is usually accompanied with a decline in systemic vascular resistance (SVR). We decided to assess effects of the peri-operative terlipressin infusion on liver donor liver transplantation recipients with respect to haemodynamics and renal parameters. Methods: After Ethical Committee approval for this prospective randomised controlled study, 50 recipients were enrolled and allotted to control (n = 25) or terlipressin group (n = 25) with simple randomisation me...

  14. Insecticide-treated nets for the prevention of malaria in pregnancy: a systematic review of randomised controlled trials.

    Directory of Open Access Journals (Sweden)

    Carol Gamble

    2007-03-01

    Full Text Available BACKGROUND: Protection from malaria with insecticide-treated bednets (ITNs during pregnancy is widely advocated, but evidence of benefit has been inconsistent. We undertook a systematic review of randomised trials. METHODS AND FINDINGS: Three cluster-randomised and two individually randomised trials met the inclusion criteria; four from Africa (n = 6,418 and one from Thailand (n = 223. In Africa, ITNs compared to no nets increased mean birth weight by 55 g (95% confidence interval [CI] 21-88, reduced low birth weight by 23% (relative risk [RR] 0.77, 95% CI 0.61-0.98, and reduced miscarriages/stillbirths by 33% (RR 0.67, 0.47-0.97 in the first few pregnancies. Placental parasitaemia was reduced by 23% in all gravidae (RR 0.77, 0.66-0.90. The effects were apparent in the cluster-randomised trials and the one individually randomised trial in Africa. The trial in Thailand, which randomised individuals to ITNs or untreated nets, showed reductions in anaemia and fetal loss in all gravidae, but not reductions in clinical malaria or low birth weight. CONCLUSIONS: ITNs used throughout pregnancy or from mid-pregnancy onwards have a beneficial impact on pregnancy outcome in malaria-endemic Africa in the first few pregnancies. The potential impact of ITNs in pregnant women and their newborns in malaria regions outside Africa requires further research.

  15. A randomised, controlled clinical study on total hip arthroplasty using 4 different bearings

    DEFF Research Database (Denmark)

    Borgwardt, Arne; Zerahn, Bo; Fabricius, Sandra D

    2017-01-01

    PURPOSE: To compare 4 different bearings in total hip arthroplasty (THA) in a randomised controlled clinical study on clinical performance. METHODS: 393 patients with osteoarthritis of the hip or avascular necrosis were included and allocated to 1 of the head-and-cup couples zirconia-on-polyethyl......PURPOSE: To compare 4 different bearings in total hip arthroplasty (THA) in a randomised controlled clinical study on clinical performance. METHODS: 393 patients with osteoarthritis of the hip or avascular necrosis were included and allocated to 1 of the head-and-cup couples zirconia...... cumulated prosthesis survival percentages and 95% confidence interval after 10 years were: group A 84.6 (75.8-93.4); group B 95.0 (89.5-100); group C 93.2 (86.7-99.7); group D 66.1 (54.5-77.7). The patients' physical function was significantly improved and remained equally good in all 4 groups, however...

  16. A randomised primal-dual algorithm for distributed radio-interferometric imaging

    CERN Document Server

    Onose, Alexandru; McEwen, Jason D; Wiaux, Yves

    2016-01-01

    Next generation radio telescopes, like the Square Kilometre Array, will acquire an unprecedented amount of data for radio astronomy. The development of fast, parallelisable or distributed algorithms for handling such large-scale data sets is of prime importance. Motivated by this, we investigate herein a convex optimisation algorithmic structure, based on primal-dual forward-backward iterations, for solving the radio interferometric imaging problem. It can encompass any convex prior of interest. It allows for the distributed processing of the measured data and introduces further flexibility by employing a probabilistic approach for the selection of the data blocks used at a given iteration. We study the reconstruction performance with respect to the data distribution and we propose the use of nonuniform probabilities for the randomised updates. Our simulations show the feasibility of the randomisation given a limited computing infrastructure as well as important computational advantages when compared to state...

  17. Ukrain – a new cancer cure? A systematic review of randomised clinical trials

    Directory of Open Access Journals (Sweden)

    Schmidt K

    2005-07-01

    Full Text Available Abstract Background Ukrain is an anticancer drug based on the extract of the plant Chelidonium majus L. Numerous pre-clinical and clinical investigations seem to suggest that Ukrain is pharmacologically active and clinically effective. We wanted therefore to critically evaluate the clinical trial data in the form of a systematic review. Methods Seven electronic databases were searched for all relevant randomised clinical trials. Data were extracted and validated by both authors, tabulated and summarised narratively. The methodological quality was assessed with the Jadad score. Results Seven trials met our inclusion criteria. Without exception, their findings suggest that Ukrain has curative effects on a range of cancers. However, the methodological quality of most studies was poor. In addition, the interpretation of several trials was impeded by other problems. Conclusion The data from randomised clinical trials suggest Ukrain to have potential as an anticancer drug. However, numerous caveats prevent a positive conclusion, and independent rigorous studies are urgently needed.

  18. Ukrain – a new cancer cure? A systematic review of randomised clinical trials

    Science.gov (United States)

    Ernst, E; Schmidt, K

    2005-01-01

    Background Ukrain is an anticancer drug based on the extract of the plant Chelidonium majus L. Numerous pre-clinical and clinical investigations seem to suggest that Ukrain is pharmacologically active and clinically effective. We wanted therefore to critically evaluate the clinical trial data in the form of a systematic review. Methods Seven electronic databases were searched for all relevant randomised clinical trials. Data were extracted and validated by both authors, tabulated and summarised narratively. The methodological quality was assessed with the Jadad score. Results Seven trials met our inclusion criteria. Without exception, their findings suggest that Ukrain has curative effects on a range of cancers. However, the methodological quality of most studies was poor. In addition, the interpretation of several trials was impeded by other problems. Conclusion The data from randomised clinical trials suggest Ukrain to have potential as an anticancer drug. However, numerous caveats prevent a positive conclusion, and independent rigorous studies are urgently needed. PMID:15992405

  19. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial

    DEFF Research Database (Denmark)

    Turpie, Alexander G G; Lassen, Michael R; Davidson, Bruce L

    2009-01-01

    arthroplasty. METHODS: In a randomised, double-blind, phase III study, 3148 patients undergoing knee arthroplasty received either oral rivaroxaban 10 mg once daily, beginning 6-8 h after surgery, or subcutaneous enoxaparin 30 mg every 12 h, starting 12-24 h after surgery. Patients had mandatory bilateral...... venography between days 11 and 15. The primary efficacy outcome was the composite of any deep-vein thrombosis, non-fatal pulmonary embolism, or death from any cause up to day 17 after surgery. Efficacy was assessed as non-inferiority of rivaroxaban compared with enoxaparin in the per-protocol population......: In a randomised, double-blind, phase III study, 3148 patients undergoing knee arthroplasty received either oral rivaroxaban 10 mg once daily, beginning 6-8 h after surgery, or subcutaneous enoxaparin 30 mg every 12 h, starting 12-24 h after surgery. Patients had mandatory bilateral venography between days 11...

  20. Extracorporeal shock-wave treatment for tennis elbow. A randomised double-blind study.

    Science.gov (United States)

    Melikyan, E Y; Shahin, E; Miles, J; Bainbridge, L C

    2003-08-01

    The efficacy of extracorporeal shock-wave therapy for tennis elbow was investigated using a single fractionated dosage in a randomised, double-blind study. Outcomes were assessed using the Disabilities of Arm, Shoulder and Hand questionnaire, measurements of grip strength, levels of pain, analgesic usage and the rate of progression to surgery. Informed consent was obtained before patients were randomised to either the treatment or placebo group. In the final assessment, 74 patients (31 men and 43 women) with a mean age of 43.4 years (35 to 71), were included. None of the outcome measures showed a statistically significant difference between the treatment and control groups (p > 0.05). All patients improved significantly over time, regardless of treatment. Our study showed no evidence that extracorporeal shock-wave therapy for tennis elbow is better than placebo.

  1. Ear acupuncture or local anaesthetics as pain relief during postpartum surgical repair: a randomised controlled trial

    DEFF Research Database (Denmark)

    Kindberg, S; Klünder, L; Strøm, J

    2009-01-01

    -hour hands-on training in the use of ear acupuncture. All midwives (n= 36) in the department had previous experience in using acupuncture for obstetric pain relief. Pain and wound healing were evaluated using validated scores. Data collection was performed by research assistants blinded towards...... treatment allocation. Randomisation was computer assisted. A total of 207 women were randomised to receive ear acupuncture (105) and local anaesthetics (102), respectively. Main outcome measures The primary outcome was pain during surgical repair. Secondary outcomes were wound healing at 24-48 hours and 14...... days postpartum, participant satisfaction, revision of wound or dyspareunia reported 6 months postpartum. Results Pain during surgical repair was more frequently reported by participants allocated to ear acupuncture compared with participants receiving local anaesthetics (89 versus 54%, P

  2. Homoeopathy for delayed onset muscle soreness: a randomised double blind placebo controlled trial.

    Science.gov (United States)

    Vickers, A J; Fisher, P; Smith, C; Wyllie, S E; Lewith, G T

    1997-01-01

    OBJECTIVE: To pilot a model for determining whether a homoeopathic medicine is superior to placebo for delayed onset muscle soreness (DOMS). DESIGN: Randomised double blind placebo controlled trial. SETTING: Physiotherapy department of a homoeopathic hospital. SUBJECTS: Sixty eight healthy volunteers (average age 30; 41% men) undertook a 10 minute period of bench stepping carrying a small weight and were randomised to a homoeopathic medicine or placebo. OUTCOME MEASURES: Mean muscle soreness in the five day period after the exercise test, symptom free days, maximum soreness score, days to no soreness, days on medication. RESULTS: The difference between group means was 0.17 in favour of placebo with 95% confidence intervals +/- 0.50. Similar results were found for other outcome measures. CONCLUSION: The study did not find benefit of the homoeopathic remedy in DOMS. Bench stepping may not be an appropriate model to evaluate the effects of a treatment on DOMS because of wide variation between subject soreness scores. PMID:9429007

  3. Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate. Planning and Management

    DEFF Research Database (Denmark)

    Semb, Gunvor; Enemark, Hans; Paulin, Gunnar

    2017-01-01

    Background and Aims This paper is an introduction to three concurrent, parallel group, randomised trials of primary surgery for patients born with complete unilateral cleft lip and palate (UCLP) outlining the development and performance of the project by ten North European cleft teams: Aarhus....../Copenhagen (Denmark), Bergen/Oslo (Norway), Gothenburg/Linköping/Stockholm (Sweden), Manchester/Belfast (UK) Method The three trials included patients born with complete unilateral cleft lip and palate (UCLP). One surgical protocol was defined to serve as a common method in each trial against which the established...... Words: Randomised control trials, Multicentre study, Scandcleft, Unilateral Cleft Lip and Palate, Palatal surgery. Running head: Scandcleft, planning and management....

  4. Does a "Level I Evidence" rating imply high quality of reporting in orthopaedic randomised controlled trials?

    OpenAIRE

    Sierevelt Inger N; Krips Rover; Struijs Peter AA; Poolman Rudolf W; Lutz Kristina H; Bhandari Mohit

    2006-01-01

    Abstract Background The Levels of Evidence Rating System is widely believed to categorize studies by quality, with Level I studies representing the highest quality evidence. We aimed to determine the reporting quality of Randomised Controlled Trials (RCTs) published in the most frequently cited general orthopaedic journals. Methods Two assessors identified orthopaedic journals that reported a level of evidence rating in their abstracts from January 2003 to December 2004 by searching the instr...

  5. A cognitive behavioural intervention to reduce sexually transmitted infections among gay men: randomised trial

    OpenAIRE

    Imrie, J.; Stephenson, J R; Cowan, F. M.; Wanigaratne, S; Billington, A. J. P.; Copas, A. J.; French, L.; French, P D; Johnson, A. M.; Behav Intervention Gay Men Project

    2001-01-01

    Objective To determine the effectiveness of a brief cognitive behavioural intervention in reducing the incidence of sexually transmitted infections among gay men.Design Randomised controlled trial with 12 months' follow up.Setting Sexual health clinic in London.Participants 343 gay men with an acute sexually transmitted infection or who reported having had unprotected anal intercourse in the past year.Main outcome measures Number of new sexually transmitted infections diagnosed during follow ...

  6. Acupressure at acupoint P6 for prevention of postoperative nausea and vomiting: a randomised clinical trial

    DEFF Research Database (Denmark)

    Majholm, Birgitte; Møller, Ann M

    2011-01-01

    Postoperative nausea and vomiting causes discomfort in many patients despite both antiemetic prophylactics and improved anaesthetic techniques. Stimulation of acupoint P6 is described as an alternative method for prophylaxis of postoperative nausea and vomiting.In a randomised, double-blinded stu......, we aimed to investigate the effect of P6 acupoint stimulation on the incidence of postoperative nausea and vomiting within 24 h postoperatively with an acupressure wristband: Vital-Band....

  7. De Quervain's Tenosynovitis and Phonophoresis: A Randomised Controlled Trial in Pregnant Females

    OpenAIRE

    Tabinda Hasan; Mahmood Fauzi

    2015-01-01

    Background: De Quervain's tenosynovitis is a common cause of wrist pain in pregnant and postpartum females. This study provides objective evidence regarding the therapeutic efficacy of phonophoresis in treating de Quervain's disease during pregnancy. Methods: In a single blind, randomised, controlled trial (n = 50), ketoprofen phonophoresis was given to the intervention group and conventional ultrasound (US) was given to controls, coupled with thumb splint immobilisation, and supervised st...

  8. Dietary outcomes of a community based intervention for mothers of young children: a randomised controlled trial

    OpenAIRE

    Jancey, Jonine Maree; Dos Remedios Monteiro, Sarojini Maria; Dhaliwal, Satvinder S.; Howat, Peter A.; Burns, Sharyn; Andrew P. Hills; Anderson, Annie S.

    2014-01-01

    Background Unhealthy dietary behaviours are one of the key risk factors for many lifestyle-related diseases worldwide. This randomised controlled trial aimed to increase the level of fruit, vegetable and fibre intake and decrease the fat and sugar consumption of mothers with young children (0–5 years) via the playgroup setting. Methods Playgroups located in 60 neighbourhoods in Perth, Western Australia were randomly assigned to an intervention (n = 249) or control group (n = 272). Those in th...

  9. Randomised trial of three approaches for marketing smoking cessation programmes to Australian general practitioners.

    OpenAIRE

    Cockburn, J.; Ruth, D.; Silagy, C.; Dobbin, M.; Reid, Y.; SCOLLO, M.; Naccarella, L

    1992-01-01

    OBJECTIVE--To compare three approaches for marketing a quit smoking intervention kit to general practitioners. DESIGN--Randomised trial of (a) personal delivery and presentation by an educational facilitator with a follow up visit six weeks later; (b) delivery to the receptionist by a friendly volunteer courier with a follow up phone call six weeks later, or (c) postal delivery with a follow up letter six weeks later. SETTING--Melbourne, Australia. SUBJECTS--264 randomly selected general prac...

  10. Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial.

    LENUS (Irish Health Repository)

    Nichol, Alistair

    2015-02-08

    Traumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis.

  11. A randomised controlled trial linking mental health inpatients to community smoking cessation supports: A study protocol

    Directory of Open Access Journals (Sweden)

    Clancy Richard

    2011-07-01

    Full Text Available Abstract Background Mental health inpatients smoke at higher rates than the general population and are disproportionately affected by tobacco dependence. Despite the advent of smoke free policies within mental health hospitals, limited systems are in place to support a cessation attempt post hospitalisation, and international evidence suggests that most smokers return to pre-admission smoking levels following discharge. This protocol describes a randomised controlled trial that will test the feasibility, acceptability and efficacy of linking inpatient smoking care with ongoing community cessation support for smokers with a mental illness. Methods/Design This study will be conducted as a randomised controlled trial. 200 smokers with an acute mental illness will be recruited from a large inpatient mental health facility. Participants will complete a baseline survey and will be randomised to either a multimodal smoking cessation intervention or provided with hospital smoking care only. Randomisation will be stratified by diagnosis (psychotic, non-psychotic. Intervention participants will be provided with a brief motivational interview in the inpatient setting and options of ongoing smoking cessation support post discharge: nicotine replacement therapy (NRT; referral to Quitline; smoking cessation groups; and fortnightly telephone support. Outcome data, including cigarettes smoked per day, quit attempts, and self-reported 7-day point prevalence abstinence (validated by exhaled carbon monoxide, will be collected via blind interview at one week, two months, four months and six months post discharge. Process information will also be collected, including the use of cessation supports and cost of the intervention. Discussion This study will provide comprehensive data on the potential of an integrated, multimodal smoking cessation intervention for persons with an acute mental illness, linking inpatient with community cessation support. Trial Registration

  12. Exploring integrative medicine for back and neck pain - a pragmatic randomised clinical pilot trial

    OpenAIRE

    2009-01-01

    Abstract Background A model for integrative medicine (IM) adapted to Swedish primary care was previously developed. The aim of this study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain. Specific objectives included the exploration of recruitment and retention rates, patient and care characteristics, clinical differences and e...

  13. Double blind randomised controlled trial of effect of metoprolol on myocardial ischaemia during endoscopic cholangiopancreatography.

    OpenAIRE

    Rosenberg, J.; Overgaard, H.; Andersen, M.; Rasmussen, V; Schulze, S.

    1996-01-01

    OBJECTIVE--To evaluate the effect of metoprolol, a beta adrenergic blocking drug, on the occurrence of myocardial ischaemia during endoscopic cholangiopancreatography. DESIGN--Double blind, randomised, controlled trial. SETTING--University Hospital. SUBJECTS--38 (two groups of 19) patients scheduled for endoscopic cholangiopancreatography. INTERVENTIONS--Metoprolol 100 mg or placebo as premedication two hours before endoscopy. MAIN OUTCOME MEASURES--Heart rate, arterial oxygen saturation by c...

  14. Using Mendelian randomisation to infer causality in depression and anxiety research.

    Science.gov (United States)

    Gage, Suzanne H; Smith, George Davey; Zammit, Stanley; Hickman, Matthew; Munafò, Marcus R

    2013-12-01

    Depression and anxiety co-occur with substance use and abuse at a high rate. Ascertaining whether substance use plays a causal role in depression and anxiety is difficult or impossible with conventional observational epidemiology. Mendelian randomisation uses genetic variants as a proxy for environmental exposures, such as substance use, which can address problems of reverse causation and residual confounding, providing stronger evidence about causality. Genetic variants can be used instead of directly measuring exposure levels, in order to gain an unbiased estimate of the effect of various exposures on depression and anxiety. The suitability of the genetic variant as a proxy can be ascertained by confirming that there is no relationship between variant and outcome in those who do not use the substance. At present, there are suitable instruments for tobacco use, so we use that as a case study. Proof-of-principle Mendelian randomisation studies using these variants have found evidence for a causal effect of smoking on body mass index. Two studies have investigated tobacco and depression using this method, but neither found strong evidence that smoking causes depression or anxiety; evidence is more consistent with a self-medication hypothesis. Mendelian randomisation represents a technique that can aid understanding of exposures that may or may not be causally related to depression and anxiety. As more suitable instruments emerge (including the use of allelic risk scores rather than individual single nucleotide polymorphisms), the effect of other substances can be investigated. Linkage disequilibrium, pleiotropy, and population stratification, which can distort Mendelian randomisation studies, are also discussed. © 2013 Wiley Periodicals, Inc.

  15. Surgery versus prolonged conservative treatment for sciatica: 5-year results of a randomised controlled trial

    OpenAIRE

    Lequin, Michiel B.; Verbaan, Dagmar; Jacobs, Wilco C. H.; Brand, Ronald; Gerrit J. Bouma; Vandertop, William P.; Peul, Wilco C; ,

    2013-01-01

    Objective This study describes the 5 years’ results of the Sciatica trial focused on pain, disability, (un)satisfactory recovery and predictors for unsatisfactory recovery. Design A randomised controlled trial. Setting Nine Dutch hospitals. Participants Five years’ follow-up data from 231 of 283 patients (82%) were collected. Intervention Early surgery or an intended 6 months of conservative treatment. Main outcome measures Scores from Roland disability questionnaire, visual analogue scale (V...

  16. Chronic hand eczema - self-management and prognosis: a study protocol for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Mollerup Annette

    2012-06-01

    Full Text Available Abstract Background Hand eczema has a one-year prevalence of approximately 10 % in the general Danish population. Often the disease becomes chronic with numerous implications for the individual’s daily life, occupation and quality of life. However, no guidelines of self-management recommendations beyond the acute stage are given. Self-management of the disease is pivotal and involves self-monitoring of the condition, medication adherence, and preventive behaviour. Interventions best to support the individual in this ongoing process need to be developed. Methods/design This paper describes the design of a randomised clinical trial to test a newly developed intervention of individual counselling versus conventional information. 300 patients consecutively referred to dermatologic treatment at two different settings are individually randomised to either the intervention programme, named ‘The Healthy Skin Clinic’ or to the control group. Block-wise randomisation according to setting and gender is carried out. The intervention offers a tool for self-monitoring; basic and specific individual counselling; the possibility of asynchronous communication with the intervention team; and an electronic patient dialogue forum. Primary outcome variable is objective assessment of the hand eczema severity performed at baseline prior to randomisation, and repeated at six months follow-up. Secondary outcome variables are dermatology related life quality and perceived global burden of disease. Discussion The trial aims at evaluating a newly developed guidance programme which is expected to support self-management of patients referred to dermatology treatment due to chronic hand eczema. The design of the protocol is pragmatic with blinding of neither participants nor the investigator. Thus, in the interpretation of the results, the investigator takes into account effects that may be attributed to actors of the interventions rather than the intervention per se as

  17. Dry needling and exercise for chronic whiplash - a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Souvlis Tina

    2009-12-01

    Full Text Available Abstract Background Chronic whiplash is a common and costly problem. Sensory hypersensitivity is a feature of chronic whiplash that is associated with poor responsiveness to physical treatments such as exercise. Modalities such as dry-needling have shown some capacity to modulate sensory hypersensitivity, suggesting that when combined with advice and exercise, such an approach may be more effective in the management of chronic whiplash. The primary aim of this project is to investigate the effectiveness of dry-needling, advice and exercise for chronic whiplash. Method/Design A double-blind randomised controlled trial will be conducted. 120 participants with chronic whiplash, grade II will be randomised to receive either 1 dry-needling, advice and exercise or 2 sham dry-needling, advice and exercise. All participants will receive an educational booklet on whiplash. Participants who are randomised to Group 1 will receive 6 treatments of combined dry-needling and exercise delivered in the first 3 weeks of the 6 week program, and 4 treatments of exercise only in the last 3 weeks of the program. Participants randomised to Group 2 will receive an identical protocol, except that a sham dry-needling technique will be used instead of dry-needling. The primary outcome measures are the Neck Disability Index (NDI and participants' perceived recovery. Outcomes will be measured at 6, 12, 24 and 52 weeks after randomization by an assessor who is blind to the group allocation of the participants. In parallel, an economic analysis will be conducted. Discussion This trial will utilise high quality trial methodologies in accordance with CONSORT guidelines. The successful completion of this trial will provide evidence of the effectiveness and cost-effectiveness of a combined treatment approach for the management of chronic whiplash. Trial registration ACTRN12609000470291

  18. REFINE (Reducing Falls in In-patient Elderly - a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sach Tracey

    2009-09-01

    Full Text Available Abstract Background Falls in hospitals are common, resulting in injury and anxiety to patients, and large costs to NHS organisations. More than half of all in-patient falls in elderly people in acute care settings occur at the bedside, during transfers or whilst getting up to go to the toilet. In the majority of cases these falls are unwitnessed. There is insufficient evidence underpinning the effectiveness of interventions to guide clinical staff regarding the reduction of falls in the elderly inpatient. New patient monitoring technologies have the potential to offer advances in falls prevention. Bedside sensor equipment can alert staff, not in the immediate vicinity, to a potential problem and avert a fall. However no studies utilizing this assistive technology have demonstrated a significant reduction in falls rates in a randomised controlled trial setting. Methods/Design The research design is an individual patient randomised controlled trial of bedside chair and bed pressure sensors, incorporating a radio-paging alerting mode to alert staff to patients rising from their bed or chair, across five acute elderly care wards in Nottingham University Hospitals NHS Trust. Participants will be randomised to bedside chair and bed sensors or to usual care (without the use of sensors. The primary outcome is the number of bedside in-patient falls. Discussion The REFINE study is the first randomised controlled trial of bedside pressure sensors in elderly inpatients in an acute NHS Trust. We will assess whether falls can be successfully and cost effectively reduced using this technology, and report on its acceptability to both patients and staff. Trial Registration ISRCTN trial number: ISRCTN44972300.

  19. Inositol for the prevention of neural tube defects: a pilot randomised controlled trial.

    Science.gov (United States)

    Greene, Nicholas D E; Leung, Kit-Yi; Gay, Victoria; Burren, Katie; Mills, Kevin; Chitty, Lyn S; Copp, Andrew J

    2016-03-28

    Although peri-conceptional folic acid (FA) supplementation can prevent a proportion of neural tube defects (NTD), there is increasing evidence that many NTD are FA non-responsive. The vitamin-like molecule inositol may offer a novel approach to preventing FA-non-responsive NTD. Inositol prevented NTD in a genetic mouse model, and was well tolerated by women in a small study of NTD recurrence. In the present study, we report the Prevention of Neural Tube Defects by Inositol (PONTI) pilot study designed to gain further experience of inositol usage in human pregnancy as a preliminary trial to a future large-scale controlled trial to evaluate efficacy of inositol in NTD prevention. Study subjects were UK women with a previous NTD pregnancy who planned to become pregnant again. Of 117 women who made contact, ninety-nine proved eligible and forty-seven agreed to be randomised (double-blind) to peri-conceptional supplementation with inositol plus FA or placebo plus FA. In total, thirty-three randomised pregnancies produced one NTD recurrence in the placebo plus FA group (n 19) and no recurrences in the inositol plus FA group (n 14). Of fifty-two women who declined randomisation, the peri-conceptional supplementation regimen and outcomes of twenty-two further pregnancies were documented. Two NTD recurred, both in women who took only FA in their next pregnancy. No adverse pregnancy events were associated with inositol supplementation. The findings of the PONTI pilot study encourage a large-scale controlled trial of inositol for NTD prevention, but indicate the need for a careful study design in view of the unwillingness of many high-risk women to be randomised.

  20. Effect of training traditional birth attendants on neonatal mortality (Lufwanyama Neonatal Survival Project): randomised controlled study

    OpenAIRE

    Gill, Christopher J.; Phiri-Mazala, Grace; Guerina, Nicholas G.; Kasimba, Joshua; Mulenga, Charity; MacLeod, William B; Waitolo, Nelson; Knapp, Anna B; Mirochnick, Mark; Mazimba, Arthur; Matthew P Fox; Sabin, Lora; Seidenberg, Philip; SIMON, Jonathon L.; Hamer, Davidson H

    2011-01-01

    Objective To determine whether training traditional birth attendants to manage several common perinatal conditions could reduce neonatal mortality in the setting of a resource poor country with limited access to healthcare. Design Prospective, cluster randomised and controlled effectiveness study. Setting Lufwanyama, an agrarian, poorly developed district located in the Copperbelt province, Zambia. All births carried out by study birth attendants occurred at mothers’ homes, in rural village s...

  1. Cancer: improving early detection and prevention. A community practice randomised trial.

    OpenAIRE

    Dietrich, A J; O'Connor, G. T.; Keller, A.; Carney, P A; Levy, D; Whaley, F. S.

    1992-01-01

    OBJECTIVE--To test the impact of physician education and facilitator assisted office system interventions on cancer early detection and preventive services. DESIGN--A randomised trial of two interventions alone and in combination. SETTING AND SUBJECTS--Physicians in 98 ambulatory care practices in the United States. INTERVENTIONS--The education intervention consisted of a day long physician meeting directed at improving knowledge, attitudes, and skills relevant to cancer prevention and early ...

  2. The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial

    OpenAIRE

    Forster Anne; Young John; Barber Sally; Clegg Andrew; Iliffe Steve

    2011-01-01

    Abstract Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE) trial is a two arm, assessor blind pilot randomised controlled trial (RCT) to a...

  3. Effects of improved home heating on asthma in community dwelling children: randomised controlled trial

    OpenAIRE

    Howden-Chapman, Philippa; Pierse, Nevil; Nicholls, Sarah; Gillespie-Bennett, Julie; Viggers, Helen; Cunningham, Malcolm; Phipps, Robyn; Boulic, Mikael; Fjällström, Pär; Free, Sarah; Chapman, Ralph; Lloyd, Bob; Wickens, Kristin; Shields, David; Baker, Michael

    2008-01-01

    Objective To assess whether non-polluting, more effective home heating (heat pump, wood pellet burner, flued gas) has a positive effect on the health of children with asthma. Design Randomised controlled trial. Setting Households in five communities in New Zealand. Participants 409 children aged 6-12 years with doctor diagnosed asthma. Interventions Installation of a non-polluting, more effective home heater before winter. The control group received a replacement heater at the end of the tria...

  4. Authentication of Radial Versus Femoral Arterial Pressure Waveform-Derived Cardiac Output With Transesophageal Echocardiography-Derived Cardiac Output Measurements in Patients Undergoing On-Pump Coronary Bypass Surgery.

    Science.gov (United States)

    Maddali, Madan Mohan; Waje, Niranjan Dilip; Sathiya, Panchatcharam Murthi

    2017-08-01

    The aim of this study was to ascertain if arterial waveform-derived cardiac output measurements from radial and femoral cannulation sites were reliable as compared with transesophageal echocardiography (TEE)-derived cardiac output (CO) values, and which of the CO measurements derived from radial and the femoral arterial pressure waveforms closely tracked simultaneously measured TEE-derived CO values. This study also aimed to ascertain if cardiopulmonary bypass (CPB) would impact the accuracy of arterial pressure-derived CO values from either of the 2 sites. A prospective observational study. Tertiary care cardiac center. Cardiac surgical patients undergoing on-pump primary coronary artery bypass surgery. Waveform-derived CO monitoring through radial and femoral artery cannulation using a FloTrac/Vigileo system. Twenty-seven consecutive cardiac surgical patients undergoing on-pump primary coronary artery bypass surgery were included in the study. Cardiac output was measured sequentially by the arterial pressure waveform analysis method from radial and femoral arterial sites and compared with simultaneously measured TEE-derived CO. Cardiac output data were obtained in triplicate at 6 predefined time intervals: before and after sternotomy, 5, 15, and 30 minutes after separation from CPB and prior to shifting the patient out of the operating room. The overall bias of the study was 0.11 and 0.27, the percentage error was 19.31 and 18.45, respectively, for radial and femoral arterial waveform-derived CO values as compared with TEE-derived CO measurements. The overall precision as compared with the TEE-derived CO values was 16.94 and 15.95 for the radial and femoral cannulation sites, respectively. The bias calculated by the Bland-Altman method suggested that CO measurements from the radial arterial site were in closer agreement with TEE-derived CO values at all time periods, and the relation was not affected by CPB. However, percentage error and precision calculations

  5. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers.

    Science.gov (United States)

    O'Cathain, Alicia; Hoddinott, Pat; Lewin, Simon; Thomas, Kate J; Young, Bridget; Adamson, Joy; Jansen, Yvonne Jfm; Mills, Nicola; Moore, Graham; Donovan, Jenny L

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full trial. We present guidance that researchers, research funders and reviewers may wish to consider when assessing or undertaking qualitative research within feasibility studies for randomised controlled trials. The guidance consists of 16 items within five domains: research questions, data collection, analysis, teamwork and reporting. Appropriate and well conducted qualitative research can make an important contribution to feasibility studies for randomised controlled trials. This guidance may help researchers to consider the full range of contributions that qualitative research can make in relation to their particular trial. The guidance may also help researchers and others to reflect on the utility of such qualitative research in practice, so that trial teams can decide when and how best to use these approaches in future studies.

  6. Evidence for non-random sampling in randomised, controlled trials by Yuhji Saitoh.

    Science.gov (United States)

    Carlisle, J B; Loadsman, J A

    2017-01-01

    A large number of randomised trials authored by Yoshitaka Fujii have been retracted, in part as a consequence of a previous analysis finding a very low probability of random sampling. Dr Yuhji Saitoh co-authored 34 of those trials and he was corresponding author for eight of them. We found a number of additional randomised, controlled trials that included baseline data, with Saitoh as corresponding author, that Fujii did not co-author. We used Monte Carlo simulations to analyse the baseline data from 32 relevant trials in total as well as an outcome (muscle twitch recovery ratios) reported in several. We also compared a series of muscle twitch recovery graphs appearing in a number of Saitoh's publications. The baseline data in 14/32 randomised, controlled trials had p sampling. Combining the continuous and categorical probabilities of the 32 included trials, we found a very low likelihood of random sampling: p = 1.27 × 10(-8) (1 in 100,000,000). The high probability of non-random sampling and the repetition of lines in multiple graphs suggest that further scrutiny of Saitoh's work is warranted. © 2016 The Association of Anaesthetists of Great Britain and Ireland.

  7. A randomised trial of the effect of postal reminders on attendance for breast screening

    Science.gov (United States)

    Allgood, Prue C; Maxwell, Anthony J; Hudson, Sue; Offman, Judith; Hutchison, Gillian; Beattie, Cathryn; Tuano-Donnelly, Raquel; Threlfall, Anthony; Summersgill, Tina; Bellis, Lesley; Robinson, Collette; Heaton, Samantha; Patnick, Julietta; Duffy, Stephen W

    2016-01-01

    Background: Some women make an informed choice not to attend breast screening, whereas others may have forgotten about the appointment. We report on a randomised trial that investigates whether a reminder letter affects attendance. Methods: Women scheduled for a breast screening appointment were randomised to either receive a reminder letter a few days before their breast screening appointment in addition to the standard invitation letter (intervention) or not (control). The primary outcome was attendance within 30 days of the first offered appointment. Secondary outcomes were attendance within 90 and 180 days. Results: In all, 11 383 (49.9%) women were randomised to the intervention and 11 445 (50.1%) to the control. In the intervention arm, 7759 (68.2%) attended within 30 days of the first offered appointment compared with 7349 (64.2%) in the control arm. This difference was significant (P<0.001). The odds ratio (OR) (95% confidence interval) for the primary end point was 1.19 (1.13–1.26). This was not significantly affected by age, socioeconomic status or type of screen (prevalent or incident). Secondary endpoint analyses supported these results. Results did differ, however, between the different centres studied. Conclusions: This study found that postal reminders increase breast screening uptake, and could be practicable to implement in the NHS Breast Screening Programme. PMID:26784123

  8. Patch: platelet transfusion in cerebral haemorrhage: study protocol for a multicentre, randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Dijkgraaf Marcel G

    2010-03-01

    Full Text Available Abstract Background Patients suffering from intracerebral haemorrhage have a poor prognosis, especially if they are using antiplatelet therapy. Currently, no effective acute treatment option for intracerebral haemorrhage exists. Limiting the early growth of intracerebral haemorrhage volume which continues the first hours after admission seems a promising strategy. Because intracerebral haemorrhage patients who are on antiplatelet therapy have been shown to be particularly at risk of early haematoma growth, platelet transfusion may have a beneficial effect. Methods/Design The primary objective is to investigate whether platelet transfusion improves outcome in intracerebral haemorrhage patients who are on antiplatelet treatment. The PATCH study is a prospective, randomised, multi-centre study with open treatment and blind endpoint evaluation. Patients will be randomised to receive platelet transfusion within six hours or standard care. The primary endpoint is functional health after three months. The main secondary endpoints are safety of platelet transfusion and the occurrence of haematoma growth. To detect an absolute poor outcome reduction of 20%, a total of 190 patients will be included. Discussion To our knowledge this is the first randomised controlled trial of platelet transfusion for an acute haemorrhagic disease. Trial registration The Netherlands National Trial Register (NTR1303

  9. A randomised, open-label study of umeclidinium versus glycopyrronium in patients with COPD

    Directory of Open Access Journals (Sweden)

    Tara Rheault

    2016-04-01

    Full Text Available This study compared the efficacy and safety of once-daily umeclidinium 62.5 µg with once-daily glycopyrronium 50 µg in patients with moderate-to-severe chronic obstructive pulmonary disease. This was a 12-week, multicentre, randomised, open-label, parallel-group study (Clinicaltrials.gov: NCT02236611. Patients were randomised 1:1 to umeclidinium 62.5 µg or glycopyrronium 50 µg administered via Ellipta or Breezhaler dry powder inhaler, respectively. The primary endpoint was trough forced expiratory volume in 1 s (FEV1 at day 85 in the per-protocol population. Other endpoints included: weighted mean FEV1 over 0–24 h and patient-reported outcomes (transition dyspnoea index score and St George's Respiratory Questionnaire total score. Adverse events were also assessed. A total of 1037 patients were randomised to treatment. Umeclidinium was non-inferior (margin: −50 mL to glycopyrronium (trough FEV1 at day 85 treatment difference: 24 mL, 95% confidence intervals: −5–54. Improvements in other endpoints were similar between treatments. Adverse event incidences were similar for umeclidinium (37% and glycopyrronium (36%. Once-daily umeclidinium was non-inferior to once-daily glycopyrronium in patients with chronic obstructive pulmonary disease in trough FEV1 at day 85. Patient-reported outcomes and safety profiles were similar for both treatments.

  10. A randomised, open-label study of umeclidinium versus glycopyrronium in patients with COPD.

    Science.gov (United States)

    Rheault, Tara; Khindri, Sanjeev; Vahdati-Bolouri, Mitra; Church, Alison; Fahy, William A

    2016-04-01

    This study compared the efficacy and safety of once-daily umeclidinium 62.5 µg with once-daily glycopyrronium 50 µg in patients with moderate-to-severe chronic obstructive pulmonary disease. This was a 12-week, multicentre, randomised, open-label, parallel-group study (Clinicaltrials.gov: NCT02236611). Patients were randomised 1:1 to umeclidinium 62.5 µg or glycopyrronium 50 µg administered via Ellipta or Breezhaler dry powder inhaler, respectively. The primary endpoint was trough forced expiratory volume in 1 s (FEV1) at day 85 in the per-protocol population. Other endpoints included: weighted mean FEV1 over 0-24 h and patient-reported outcomes (transition dyspnoea index score and St George's Respiratory Questionnaire total score). Adverse events were also assessed. A total of 1037 patients were randomised to treatment. Umeclidinium was non-inferior (margin: -50 mL) to glycopyrronium (trough FEV1 at day 85 treatment difference: 24 mL, 95% confidence intervals: -5-54). Improvements in other endpoints were similar between treatments. Adverse event incidences were similar for umeclidinium (37%) and glycopyrronium (36%). Once-daily umeclidinium was non-inferior to once-daily glycopyrronium in patients with chronic obstructive pulmonary disease in trough FEV1 at day 85. Patient-reported outcomes and safety profiles were similar for both treatments.

  11. Assessing the Causality between Blood Pressure and Retinal Vascular Caliber through Mendelian Randomisation

    Science.gov (United States)

    Li, Ling-Jun; Liao, Jiemin; Cheung, Carol Yim-Lui; Ikram, M. Kamran; Shyong, Tai E.; Wong, Tien-Yin; Cheng, Ching-Yu

    2016-02-01

    We aimed to determine the association between blood pressure (BP) and retinal vascular caliber changes that were free from confounders and reverse causation by using Mendelian randomisation. A total of 6528 participants from a multi-ethnic cohort (Chinese, Malays, and Indians) in Singapore were included in this study. Retinal arteriolar and venular caliber was measured by a semi-automated computer program. Genotyping was done using Illumina 610-quad chips. Meta-analysis of association between BP, and retinal arteriolar and venular caliber across three ethnic groups was performed both in conventional linear regression and Mendelian randomisation framework with a genetic risk score of BP as an instrumental variable. In multiple linear regression models, each 10 mm Hg increase in systolic BP, diastolic BP, and mean arterial BP (MAP) was associated with significant decreases in retinal arteriolar caliber of a 1.4, 3.0, and 2.6 μm, and significant decreases in retinal venular caliber of a 0.6, 0.7, and 0.9 μm, respectively. In a Mendelian randomisation model, only associations between DBP and MAP and retinal arteriolar narrowing remained yet its significance was greatly reduced. Our data showed weak evidence of a causal relationship between elevated BP and retinal arteriolar narrowing.

  12. Calculating the probability of random sampling for continuous variables in submitted or published randomised controlled trials.

    Science.gov (United States)

    Carlisle, J B; Dexter, F; Pandit, J J; Shafer, S L; Yentis, S M

    2015-07-01

    In a previous paper, one of the authors (JBC) used a chi-squared method to analyse the means (SD) of baseline variables, such as height or weight, from randomised controlled trials by Fujii et al., concluding that the probabilities that the reported distributions arose by chance were infinitesimally small. Subsequent testing of that chi-squared method, using simulation, suggested that the method was incorrect. This paper corrects the chi-squared method and tests its performance and the performance of Monte Carlo simulations and ANOVA to analyse the probability of random sampling. The corrected chi-squared method and ANOVA method became inaccurate when applied to means that were reported imprecisely. Monte Carlo simulations confirmed that baseline data from 158 randomised controlled trials by Fujii et al. were different to those from 329 trials published by other authors and that the distribution of Fujii et al.'s data were different to the expected distribution, both p non-random (i.e. unreliable) data in randomised controlled trials submitted to journals. © 2015 The Association of Anaesthetists of Great Britain and Ireland.

  13. Managing Injuries of the Neck Trial (MINT: design of a randomised controlled trial of treatments for whiplash associated disorders

    Directory of Open Access Journals (Sweden)

    Williamson Esther M

    2007-01-01

    Full Text Available Abstract Background A substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED, followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of The Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks. Methods Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI, and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out. Conclusion This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised.

  14. The Women's international study of long-duration oestrogen after menopause (WISDOM: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Meade Tom W

    2007-02-01

    Full Text Available Abstract Background At the time of feasibility work and final design of the trial there was no randomised control trial evidence for the long-term risks and benefits of hormone replacement therapy. Observational studies had suggested that long term use of estrogen was likely to be associated, amongst other things, with reduced risks of osteoporosis and ischaemic heart disease and increased risks of breast and endometrial cancer. Concomitant use of progestogens had been shown to protect against endometrial cancer, but there were few data showing how progestogen might affect estrogen actions on other conditions. Disease specific risks from observational studies suggested that, overall, long-term HRT was likely to be beneficial. Several studies showed that mortality from all causes was lower in HRT users than in non-users. Some secondary cardiovascular prevention trials were ongoing but evidence was also required for a range of outcomes in healthy women. The WISDOM trial was designed to compare combined estrogen and progestogen versus placebo, and estrogen alone versus combined estrogen and progestogen. During the development of WISDOM the Women's Health Initiative trial was designed, funded and started in the US. Design Randomised, placebo, controlled, trial. Methods The trial was set in general practices in the UK (384, Australia (94, and New Zealand (24. In these practices 284175 women aged 50–69 years were registered with 226282 potentially eligible. We sought to randomise 22300 postmenopausal women aged 50 – 69 and treat for ten years. The interventions were: conjugated equine estrogens, 0.625 mg orally daily; conjugated equine estrogens plus medroxyprogesterone acetate 2.5/5.0 mg orally daily; matched placebo. Primary outcome measures were: major cardiovascular disease, osteoporotic fractures, breast cancer and dementia. Secondary outcomes were: other cancers, all cause death, venous thromboembolism and cerebro-vascular disease. Results

  15. 双氧水工作液泵泄漏故障分析及对策%Solution to Failures of Mechanical Seal on Pumps Transporting Working Medium during H2O2 Production

    Institute of Scientific and Technical Information of China (English)

    陈潜; 李进富

    2009-01-01

    针对双氧水生产中的工作液输送泵的机械密封泄漏故障进行了失效分析.经过密封理论计算和输送的工作液中所含的主要成分的化学物理特性的研究,发现引起密封失效的主要原因是密封冲洗方案和"O"型圈材料的选择有误.经调整机械冲洗方案和更换"O"型圈材料后,机械密封泄漏问题解决.%The failures occurred in mechanical seal on pumps transporting working medium during H202 production were analyzed. Through calculations on seal theoreties and research on chemical and physical characteristics of main elements in working medium, the causations were clarified. The main causations of those failures were incorrect choice of type of seal plan and improper material of "O" ring. ARer the material of"O" ring and seal plan were changed, the mechanical seal was successfully used in practice accordingly.Keyworfls: pumps transporting working medium during H2O2 production; meehauieal seal; leakage

  16. Same-admission versus interval cholecystectomy for mild gallstone pancreatitis (PONCHO): a multicentre randomised controlled trial.

    Science.gov (United States)

    da Costa, David W; Bouwense, Stefan A; Schepers, Nicolien J; Besselink, Marc G; van Santvoort, Hjalmar C; van Brunschot, Sandra; Bakker, Olaf J; Bollen, Thomas L; Dejong, Cornelis H; van Goor, Harry; Boermeester, Marja A; Bruno, Marco J; van Eijck, Casper H; Timmer, Robin; Weusten, Bas L; Consten, Esther C; Brink, Menno A; Spanier, B W Marcel; Bilgen, Ernst Jan Spillenaar; Nieuwenhuijs, Vincent B; Hofker, H Sijbrand; Rosman, Camiel; Voorburg, Annet M; Bosscha, Koop; van Duijvendijk, Peter; Gerritsen, Jos J; Heisterkamp, Joos; de Hingh, Ignace H; Witteman, Ben J; Kruyt, Philip M; Scheepers, Joris J; Molenaar, I Quintus; Schaapherder, Alexander F; Manusama, Eric R; van der Waaij, Laurens A; van Unen, Jacco; Dijkgraaf, Marcel G; van Ramshorst, Bert; Gooszen, Hein G; Boerma, Djamila

    2015-09-26

    In patients with mild gallstone pancreatitis, cholecystectomy during the same hospital admission might reduce the risk of recurrent gallstone-related complications, compared with the more commonly used strategy of interval cholecystectomy. However, evidence to support same-admission cholecystectomy is poor, and concerns exist about an increased risk of cholecystectomy-related complications with this approach. In this study, we aimed to compare same-admission and interval cholecystectomy, with the hypothesis that same-admission cholecystectomy would reduce the risk of recurrent gallstone-related complications without increasing the difficulty of surgery. For this multicentre, parallel-group, assessor-masked, randomised controlled superiority trial, inpatients recovering from mild gallstone pancreatitis at 23 hospitals in the Netherlands (with hospital discharge foreseen within 48 h) were assessed for eligibility. Adult patients (aged ≥18 years) were eligible for randomisation if they had a serum C-reactive protein concentration less than 100 mg/L, no need for opioid analgesics, and could tolerate a normal oral diet. Patients with American Society of Anesthesiologists (ASA) class III physical status who were older than 75 years of age, all ASA class IV patients, those with chronic pancreatitis, and those with ongoing alcohol misuse were excluded. A central study coordinator randomly assigned eligible patients (1:1) by computer-based randomisation, with varying block sizes of two and four patients, to cholecystectomy within 3 days of randomisation (same-admission cholecystectomy) or to discharge and cholecystectomy 25-30 days after randomisation (interval cholecystectomy). Randomisation was stratified by centre and by whether or not endoscopic sphincterotomy had been done. Neither investigators nor participants were masked to group assignment. The primary endpoint was a composite of readmission for recurrent gallstone-related complications (pancreatitis, cholangitis

  17. Systematic review of enriched enrolment, randomised withdrawal trial designs in chronic pain: a new framework for design and reporting.

    Science.gov (United States)

    Moore, R Andrew; Wiffen, Philip J; Eccleston, Christopher; Derry, Sheena; Baron, Ralf; Bell, Rae F; Furlan, Andrea D; Gilron, Ian; Haroutounian, Simon; Katz, Nathaniel P; Lipman, Arthur G; Morley, Stephen; Peloso, Paul M; Quessy, Steve N; Seers, Kate; Strassels, Scott A; Straube, Sebastian

    2015-08-01

    Enriched enrolment, randomised withdrawal (EERW) pain trials select, before randomisation, patients who respond by demonstrating a predetermined degree of pain relief and acceptance of adverse events. There is uncertainty over the value of this design. We report a systematic review of EERW trials in chronic noncancer pain together with a critical appraisal of methods and potential biases in the methods used and recommendations for the design and reporting of future EERW trials. Electronic and other searches found 25 EERW trials published between 1995 and June 2014, involving 5669 patients in a randomised withdrawal phase comparing drug with placebo; 13 (median, 107 patients) had a randomised withdrawal phase of 6 weeks or less, and 12 (median, 334) lasted 12 to 26 weeks. Risks of bias included short duration, inadequate outcome definition, incomplete outcome data reporting, small size, and inadequate dose tapering on randomisation to placebo. Active treatment was usually better than placebo (22/25 trials). This review reduces the uncertainty around the value of EERW trials in pain. If properly designed, conducted, and reported, they are feasible and useful for making decisions about pain therapies. Shorter, small studies can be explanatory; longer, larger studies can inform practice. Current evidence is inadequate for valid comparisons in outcome between EERW and classical trials, although no gross differences were found. This systematic review provides a framework for assessing potential biases and the value of the EERW trials, and for the design of future studies by making recommendations for the conduct and reporting of EERW trials.

  18. Efects of Trimetazidine On-pump Coronary Artery Bypass Grarting in Patients with IL-6, IL-8%曲美他嗪对非体外循环冠脉搭桥术患者IL-6、IL-8的影响

    Institute of Scientific and Technical Information of China (English)

    宋书田; 张彬; 张楠; 杨明; 白传明; 周继梧

    2011-01-01

    目的:观察曲美他嗪对非体外循环冠状动脉(冠脉)旁路移植术(of-pump coronary artery bypass,OPCAB)患者白介素6(interleukin-6,IL-6)和白介素8(interleukin-8,IL-8)浓度的影响.方法:将103例于我院择期行OPCAB的冠心病患者随机分为曲美他嗪组(52例)和对照组(51例).分别于术前、吻合旁路血管开放后6h、12h、24h、48h抽取静脉血,采用放免法检测血清IL-6和IL-8浓度.结果:2组患者临床特征及手术桥血管情况无统计学意义.曲美他嗪组IL-6浓度在术后6h[(225±16)、(515±81)ng/L]和术后12h[(172±5)、(285±11)ng/L]明显低于对照组(P<0.05).曲美他嗪组的IL-8浓度在术后12h[(638±30)、(893±59)ng/L]和24h[(497±16)、(589±26)ng/L]显著低于对照组(P<0.01).结论:曲美他嗪可降低OPCAB患者IL-6和IL-8的释放.%Objective:To observe the effects of trimetazidine on serum of the patients ,interleukin-6 and interleukin-8 underwent offpump coronary artery bypass.Methods:One hundred and three patients who underwent off-pump coronary artery bypass randomly divided into trimetazidine group(52 cases) and control group(51 cases).To draw vein blood preoperative,postoperative six hours,postoperative twelve hours,postoperative twenty-four hours and postoperative forty-eight hours for analyze interleukin-6 and interleukin-8.Results:There was no significant difference between two groups of clinical characterizes and grafts.The serum interleukin-6 of trimetazidine group was lower than control group after surgery six hours and twelve hours, respectively(P<0.05).The serum interleukin-8 of trimetazidine group was lower than control group after surgery twelve hours and twenty-four hours, respectively(P<0.01).Conclusion:Trimetazidine may reduce the release of the serum level of interleukin-6 and interleukin-8 the patients underwent off-pump coronary artery bypass.

  19. A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis

    DEFF Research Database (Denmark)

    Nielsen, Hans Henrik Møller; Klaaborg, Kaj E; Nissen, Henrik

    2012-01-01

    In a prospective randomised trial we aimed to compare transapical transcatheter aortic valve implantation (a-TAVI) with surgical aortic valve replacement (SAVR) in operable elderly patients.......In a prospective randomised trial we aimed to compare transapical transcatheter aortic valve implantation (a-TAVI) with surgical aortic valve replacement (SAVR) in operable elderly patients....

  20. Physical therapy plus general practitioners' care versus general practitioners' care alone for sciatica: a randomised clinical trial with a 12-month follow-up.

    NARCIS (Netherlands)

    Luijsterburg, P.A.; Verhagen, A.P.; Ostelo, R.W.J.G.; Hoogen, H.J.M. van den; Peul, W.C.; Avezaat, C.J.; Koes, B.W.

    2008-01-01

    A randomised clinical trial in primary care with a 12-months follow-up period. About 135 patients with acute sciatica (recruited from May 2003 to November 2004) were randomised in two groups: (1) the intervention group received physical therapy (PT) added to the general practitioners' care, and (2)

  1. Physical therapy plus general practitioners' care versus general practitioners' care alone for sciatica: A randomised clinical trial with a 12-month follow-up

    NARCIS (Netherlands)

    P.A.J. Luijsterburg (Pim); A.P. Verhagen (Arianne); R.W.J.G. Ostelo (Raymond); H.J. van den Hoogen (Hans); W.C. Peul (Wilco); C.J.J. Avezaat (Cees); B.W. Koes (Bart)

    2008-01-01

    textabstractA randomised clinical trial in primary care with a 12-months follow-up period. About 135 patients with acute sciatica (recruited from May 2003 to November 2004) were randomised in two groups: (1) the intervention group received physical therapy (PT) added to the general practitioners' ca

  2. Differential clinical outcomes after 1 year versus 5 years in a randomised comparison of zotarolimus-eluting and sirolimus-eluting coronary stents (the SORT OUT III study)

    DEFF Research Database (Denmark)

    Maeng, Michael; Tilsted, Hans-Henrik; Jensen, Lisette Okkels

    2014-01-01

    -eluting stent implantation to the zotarolimus-eluting Endeavor Sprint stent (Medtronic, Santa Rosa, CA, USA) or the sirolimus-eluting Cypher Select Plus stent (Cordis, Johnson & Johnson, Warren, NJ, USA). Randomisation of participants was achieved by computer-generated block randomisation and a telephone...... with coronary drug-eluting stent implantation. FUNDING: Cordis and Medtronic....

  3. Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures.Three months follow up in a clinical randomised study

    DEFF Research Database (Denmark)

    Rousing, Rikke

    2008-01-01

    Abstract Study design. Clinical randomised study.    Objective. The aim of this study is to compare PVP to conservative treatment of patients with osteoporotic vertebral fractures in a clinical randomised study with respect to pain, physical and mental outcome, and to asses the risk of adjacent f...

  4. Using Variable Speed Control on Pump Application

    Directory of Open Access Journals (Sweden)

    Dr.Sc. Aida Spahiu

    2012-06-01

    Full Text Available Pumps are one of the most common variable speed drive (VSD system applications and special interest has focused on improving their energy efficiency by using variable speed control instead of throttling or other less efficient flow control methods. Pumps are the single largest user of electricity in industry in the European Union, consuming 160 TWh per annum of electricity and accounting for 79 million tonnes of carbon dioxide (CO2 emissions [1]. Centrifugal pumps are the most likely pump style to provide a favorable return based on energy savings when applied with a variable speed drive. To help illustrate this, are conducted benchmark testing to document various head and flow scenarios and their corresponding effect on energy savings. Paper shows the relationship of static and friction head in the energy efficiency equation and the effect of motor, pump and VSD efficiencies. The received results are good reference points for engineers and managers of water sector in Albania to select the best prospects for maximizing efficiency and energy savings.

  5. Improving community ambulation after hip fracture: protocol for a randomised, controlled trial

    Science.gov (United States)

    Orwig, D; Mangione, KK; Baumgarten, M; Terrin, M; Fortinsky, R; Kenny, AM; Gruber-Baldini, AL; Beamer, B; Tosteson, ANA; Shardell, M; Magder, L; Binder, E; Koval, K; Resnick, B; Craik, RL; Magaziner, J

    2017-01-01

    Introduction After a hip fracture in older persons, significant disability often remains; dependency in functional activities commonly persists beyond 3 months after surgery. Endurance, dynamic balance, quadriceps strength, and function are compromised, and contribute to an inability to walk independently in the community. In the United States, people aged 65 years and older are eligible to receive Medicare funding for physiotherapy for a limited time after a hip fracture. A goal of outpatient physiotherapy is independent and safe household ambulation 2 to 3 months after surgery. Current Medicare-reimbursed post-hip-fracture rehabilitation fails to return many patients to pre-fracture levels of function. Interventions delivered in the home after usual hip fracture physiotherapy has ended could promote higher levels of functional independence in these frail and older adult patients. Primary objective To evaluate the effect of a specific multicomponent physiotherapy intervention (PUSH), compared with a non-specific multi-component control physiotherapy intervention (PULSE), on the ability to ambulate independently in the community 16 weeks after randomisation. Design Parallel, two-group randomised multicentre trial of 210 older adults with a hip fracture assessed at baseline and 16 weeks after randomisation, and at 40 weeks after randomisation for a subset of approximately 150 participants. Participants and setting A total of 210 hip fracture patients are being enrolled at three clinical sites and randomised up to 26 weeks after admission. Study inclusion criteria are: closed, non-pathologic, minimal trauma hip fracture with surgical fixation; aged ≥ 60 years at the time of randomisation; community residing at the time of fracture and randomisation; ambulating without human assistance 2 months prior to fracture; and being unable to walk at least 300 m in 6 minutes at baseline. Participants are ineligible if the interventions are deemed to be unsafe or unfeasible

  6. 'Third wave' cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial

    DEFF Research Database (Denmark)

    Jakobsen, Janus Christian; Gluud, Christian Nyfeldt; Kongerslev, Mickey Toftkjær

    2012-01-01

    Background: Most interventions for depression have shown small or no effects. 'Third wave' cognitive therapy and mentalization-based therapy have both gained some ground as treatments of psychological problems. No randomised trial has compared the effects of these two interventions for patients...... with major depression.Methods/ design: We plan a randomised, parallel group, assessor-blinded superiority clinical trial. During two years we will include 84 consecutive adult participants diagnosed with major depressive disorder. The participants will be randomised to either 'third wave' cognitive therapy...... versus mentalization-based therapy. The primary outcome will be the Hamilton Rating Scale for Depression at cessation of treatment at 18 weeks. Secondary outcomes will be the proportion of patients with remission, Symptom Checklist 90 Revised, Beck's Depression Inventory, and The World Health...

  7. Effect of exercise training on C reactive protein: a systematic review and meta-analysis of randomised and non-randomised controlled trials.

    Science.gov (United States)

    Fedewa, Michael V; Hathaway, Elizabeth D; Ward-Ritacco, Christie L

    2017-04-01

    C-reactive protein (CRP) is a marker of chronic systemic inflammation frequently used in cardiovascular disease risk assessment. The purpose of this meta-analysis was to provide a quantitative estimate of the magnitude of change in CRP following participation in physical exercise interventions. All studies included in the meta-analysis were peer reviewed and published in English. Human participants were assigned to a non-exercise comparison group or exercise training group, with the intervention lasting ≥2 weeks. CRP levels were measured at baseline, during and/or after completion of the exercise training programme. Random-effects models were used to aggregate a mean effect size (ES), 95% CIs and potential moderators. 83 randomised and non-randomised controlled trials met the inclusion criteria and resulted in 143 effects (n=3769). The mean ES of 0.26 (95% CI 0.18 to 0.34, pexercise training. A decrease in body mass index (BMI; β=1.20, SE=0.25, pExercise training led to a greater reduction in CRP when accompanied by a decrease in BMI (ES=0.38, 95% CI 0.26 to 0.50); however, a significant improvement in CRP occurred in the absence of weight loss (ES=0.19, 95% CI 0.10 to 0.28; both pexercise training is associated with a decrease in CRP levels regardless of the age or sex of the individual; however, greater improvements in CRP level occur with a decrease in BMI or %Fat. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  8. The OPERA trial: protocol for a randomised trial of an exercise intervention for older people in residential and nursing accommodation.

    Science.gov (United States)

    Underwood, Martin; Eldridge, Sandra; Lamb, Sallie; Potter, Rachel; Sheehan, Bartley; Slowther, Anne-Marie; Taylor, Stephanie; Thorogood, Margaret; Weich, Scott

    2011-02-02

    Depression is common in residents of Residential and Nursing homes (RNHs). It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents. OPERA is a cluster randomised controlled trial. RNHs are randomised to one of two groups with interventions lasting 12 months. INTERVENTION GROUP: a depression awareness and physical activity training session for care home staff, plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups. The intervention lasts for one year from randomisation, or a depression awareness training session for care home staff.Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study. Our primary outcome is the prevalence of depressive symptoms, a GDS-15 score of five or more, in all participants at the end of the one year intervention period. Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to randomisation. Other secondary outcomes include, fear of falling, mobility, fractures, pain, cognition, costs and health related quality of life. We aimed to randomise 77 RNHs. Home recruitment was completed in May 2010; 78 homes have been randomised. Follow up will finish in May 2011 and results will be available late 2011. [ISRCTN: ISRCTN43769277].

  9. Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST: study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    McColl Elaine

    2011-06-01

    Full Text Available Abstract Background High blood pressure during acute stroke is associated with poorer stroke outcome. Previous trials have failed to show benefit from lowering blood pressure but treatment may have been commenced too late to be effective. The earliest that acute stroke treatments could be initiated is during contact with the emergency medical services (paramedics. However, experience of pre-hospital clinical trials is limited and logistical challenges are likely to be greater than for trials performed in other settings. We report the protocol for a pilot randomised controlled trial of paramedic initiated blood pressure lowering treatment for hypertension in acute stroke. Methods Trial Design: Double blind parallel group external pilot randomised controlled trial. Setting: Participant recruitment and initial treatment by North East Ambulance Service research trained paramedics responding to the emergency call. Continued treatment in three study hospitals. Participants: Target is recruitment of 60 adults with acute arm weakness due to suspected stroke (within 3 hours of symptom onset and hypertension (systolic BP>160 mmHg. Intervention: Lisinopril 5-10 mg (intervention group, matched placebo (control group, daily for 7 days. Randomisation: Study medication contained within identical pre-randomised "trial packs" carried by research trained paramedics. Outcomes: Study feasibility (recruitment rate, compliance with data collection and clinical data to inform the design of a definitive randomised controlled trial (blood pressure monitoring, National Institute of Health Stroke Scale, Barthel ADL Index, Modified Rankin Scale, renal function. Discussion This pilot study is assessing the feasibility of a randomised controlled trial of paramedic initiated lisinopril for hypertension early after the onset of acute stroke. The results will inform the design of a definitive RCT to evaluate the effects of very early blood pressure lowering in acute stroke

  10. The OPERA trial: protocol for a randomised trial of an exercise intervention for older people in residential and nursing accommodation

    Directory of Open Access Journals (Sweden)

    Taylor Stephanie

    2011-02-01

    Full Text Available Abstract Background Depression is common in residents of Residential and Nursing homes (RNHs. It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents. Method OPERA is a cluster randomised controlled trial. RNHs are randomised to one of two groups with interventions lasting 12 months Intervention group: a depression awareness and physical activity training session for care home staff, plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups. The intervention lasts for one year from randomisation, or Control group: a depression awareness training session for care home staff. Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study. Our primary outcome is the prevalence of depressive symptoms, a GDS-15 score of five or more, in all participants at the end of the one year intervention period. Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to randomisation. Other secondary outcomes include, fear of falling, mobility, fractures, pain, cognition, costs and health related quality of life. We aimed to randomise 77 RNHs. Discussion Home recruitment was completed in May 2010; 78 homes have been randomised. Follow up will finish in May 2011 and results will be available late 2011. Trial Registration [ISRCTN: ISRCTN43769277

  11. Effect of Centrifugal Pump Blade Inlet Geometry on Pump Cavitation Performance%离心泵的叶片进口几何形状对泵汽蚀性能的影响

    Institute of Scientific and Technical Information of China (English)

    张建华; 楚武利; 马文瑛

    2012-01-01

    为了改善离心泵内的汽蚀性能,以ZA150 -315石油化工离心泵为研究对象,在离心叶轮基本外尺寸和设计转速相同的情况下,以3种不同厚度变化规律构造3种离心泵叶轮,运用FLUENT软件进行数值模拟计算,得到了汽蚀发生时泵内部气-液两相分布规律和压力分布规律.分析表明:叶片进口段的形状影响泵的汽蚀性能.叶片进口段形状越接近流线型泵的抗汽蚀性能越好,加大叶片进口段曲率半径可以降低泵的汽蚀余量,改善泵的汽蚀性能.%In order to improve centrifugal pump cavitation performance, ZA150 - 315 petrochemical centrifugal pump were studied. With the basic exterior parameters and rotational speed of centrifugal impeller were fixed, centrifugal impellers were generated with three different changes of thickness, the vapor - liquid two - phase distribution and pressure distribution of centrifugal impeller inner flow were obtained by using computer fluid dynamic method. Analysis of simulated results demonstrate that, the blade inlet geometry have effect on pump cavitation performance. The geometry of the blade inlet closer to streamline, the better to the pump anti - cavitation performance, increasing the radius of curvature of the blade inlet section can reduce the pump cavitation allowance, improving pump cavitation performance.

  12. The informed consent process in randomised controlled trials: a nurse-led process.

    Science.gov (United States)

    Cresswell, Pip; Gilmour, Jean

    2014-03-01

    Clinical trials are carried out with human participants to answer questions about the best way to diagnose, treat and prevent illness. Participants must give informed consent to take part in clinical trials that requires understanding of how clinical trials work and their purpose. Randomised controlled trials provide strong evidence but their complex design is difficult for both clinicians and participants to understand. Increasingly, ensuring informed consent in randomised controlled trials has become part of the clinical research nurse role. The aim of this study was to explore in depth the clinical research nurse role in the informed consent process using a qualitative descriptive approach. Three clinical research nurses were interviewed and data analysed using a thematic analysis approach. Three themes were identified to describe the process of ensuring informed consent. The first theme, Preparatory partnerships, canvassed the relationships required prior to initiation of the informed consent process. The second theme, Partnering the participant, emphasises the need for ensuring voluntariness and understanding, along with patient advocacy. The third theme, Partnership with the project, highlights the clinical research nurse contribution to the capacity of the trial to answer the research question through appropriate recruiting and follow up of participants. Gaining informed consent in randomised controlled trials was complex and required multiple partnerships. A wide variety of skills was used to protect the safety of trial participants and promote quality research. The information from this study contributes to a greater understanding of the clinical research nurse role, and suggests the informed consent process in trials can be a nurse-led one. In order to gain collegial, employer and industry recognition it is important this aspect of the nursing role is acknowledged.

  13. Deep brain stimulation in early stage Parkinson's disease: operative experience from a prospective randomised clinical trial.

    Science.gov (United States)

    Kahn, Elyne; D'Haese, Pierre-Francois; Dawant, Benoit; Allen, Laura; Kao, Chris; Charles, P David; Konrad, Peter

    2012-02-01

    Recent evidence suggests that deep brain stimulation of the subthalamic nucleus (STN-DBS) may have a disease modifying effect in early Parkinson's disease (PD). A randomised, prospective study is underway to determine whether STN-DBS in early PD is safe and tolerable. 15 of 30 early PD patients were randomised to receive STN-DBS implants in an institutional review board approved protocol. Operative technique, location of DBS leads and perioperative adverse events are reported. Active contact used for stimulation in these patients was compared with 47 advanced PD patients undergoing an identical procedure by the same surgeon. 14 of the 15 patients did not sustain any long term (>3 months) complications from the surgery. One subject suffered a stroke resulting in mild cognitive changes and slight right arm and face weakness. The average optimal contact used in symptomatic treatment of early PD patients was: anterior -1.1±1.7 mm, lateral 10.7±1.7 mm and superior -3.3±2.5 mm (anterior and posterior commissure coordinates). This location is statistically no different (0.77 mm, p>0.05) than the optimal contact used in the treatment of 47 advanced PD patients. The perioperative adverse events in this trial of subjects with early stage PD are comparable with those reported for STN-DBS in advanced PD. The active contact position used in early PD is not significantly different from that used in late stage disease. This is the first report of the operative experience from a randomised, surgical versus best medical therapy trial for the early treatment of PD.

  14. Persistent occiput posterior: OUTcomes following digital rotation: a pilot randomised controlled trial.

    Science.gov (United States)

    Graham, Kathryn; Phipps, Hala; Hyett, Jon A; Ludlow, Joanne P; Mackie, Adam; Marren, Anthony; De Vries, Bradley

    2014-06-01

    To determine the feasibility of a multicentre randomised controlled trial (RCT) to investigate whether digital rotation of the fetal head from occiput posterior (OP) position in the second stage of labour reduces the risk of operative delivery (defined as caesarean section (CS) or instrumental delivery). We conducted the study between December 2010 and December 2011 in a tertiary referral hospital in Australia. A transabdominal ultrasound was performed early in the second stage of labour on women with cephalic, singleton pregnancies to determine the fetal position. Those women with a fetus in the OP position were randomised to either a digital rotation or a sham procedure. In all other ways, participants received their usual intrapartum care. Data regarding demographics, mode of delivery, labour, post natal period and neonatal outcomes were collected. One thousand and four women were consented, 834 achieved full dilatation, and 30 were randomised. An additional portable ultrasound scan and a blinded 'sham' digital rotation were acceptable to women and staff. Operative delivery rates were 13/15 in the digital rotation (four CS and nine instrumental) and 12/15 in the sham (three CS and nine instrumental) groups, respectively. A large double-blinded multicentre RCT would be feasible and acceptable to women and staff. Strategies to improve recruitment such as consenting women with an effective epidural in active labour should be considered. This would be the first RCT to answer a clinically important question which could significantly affect the operative delivery rate in Australia and internationally. © 2014 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  15. Reduction of adverse effects from intravenous acetylcysteine treatment for paracetamol poisoning: a randomised controlled trial.

    Science.gov (United States)

    Bateman, D Nicholas; Dear, James W; Thanacoody, H K Ruben; Thomas, Simon H L; Eddleston, Michael; Sandilands, Euan A; Coyle, Judy; Cooper, Jamie G; Rodriguez, Aryelly; Butcher, Isabella; Lewis, Steff C; Vliegenthart, A D Bastiaan; Veiraiah, Aravindan; Webb, David J; Gray, Alasdair

    2014-02-22

    Paracetamol poisoning is common worldwide. It is treated with intravenous acetylcysteine, but the standard regimen is complex and associated with frequent adverse effects related to concentration, which can cause treatment interruption. We aimed to ascertain whether adverse effects could be reduced with either a shorter modified acetylcysteine schedule, antiemetic pretreatment, or both. We undertook a double-blind, randomised factorial study at three UK hospitals, between Sept 6, 2010, and Dec 31, 2012. We randomly allocated patients with acute paracetamol overdose to either the standard intravenous acetylcysteine regimen (duration 20·25 h) or a shorter (12 h) modified protocol, with or without intravenous ondansetron pretreatment (4 mg). Masking was achieved by infusion of 5% dextrose (during acetylcysteine delivery) or saline (for antiemetic pretreatment). Randomisation was done via the internet and included a minimisation procedure by prognostic factors. The primary outcome was absence of vomiting, retching, or need for rescue antiemetic treatment at 2 h. Prespecified secondary outcomes included a greater than 50% increase in alanine aminotransferase activity over the admission value. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov (identifier NCT01050270). Of 222 patients who underwent randomisation, 217 were assessable 2 h after the start of acetylcysteine treatment. Vomiting, retching, or need for rescue antiemetic treatment at 2 h was reported in 39 of 108 patients assigned to the shorter modified protocol compared with 71 of 109 allocated to the standard acetylcysteine regimen (adjusted odds ratio 0·26, 97·5% CI 0·13-0·52; pinferiority of the shorter protocol versus the standard approach; therefore, further research is needed to confirm the efficacy of the 12 h modified acetylcysteine regimen. Chief Scientist Office of the Scottish Government. Copyright © 2014 Bateman et al. Open Access article distributed under

  16. Hypotensive effects of hawthorn for patients with diabetes taking prescription drugs: a randomised controlled trial.

    Science.gov (United States)

    Walker, Ann F; Marakis, Georgios; Simpson, Eleanor; Hope, Jessica L; Robinson, Paul A; Hassanein, Mohamed; Simpson, Hugh C R

    2006-06-01

    Hawthorn (Crataegus laevigata) leaves, flowers and berries are used by herbal practitioners in the UK to treat hypertension in conjunction with prescribed drugs. Small-scale human studies support this approach. To investigate the effects of hawthorn for hypertension in patients with type 2 diabetes taking prescribed drugs. Randomised controlled trial. General practices in Reading, UK. Patients with type 2 diabetes (n = 79) were randomised to daily 1200 mg hawthorn extract (n = 39) or placebo (n = 40) for 16 weeks. At baseline and outcome a wellbeing questionnaire was completed and blood pressure and fasting blood samples taken. A food frequency questionnaire estimated nutrient intake. Hypotensive drugs were used by 71% of the study population with a mean intake of 4.4 hypoglycaemic and/or hypotensive drugs. Fat intake was lower and sugar intake higher than recommendations, and low micronutrient intake was prevalent. There was a significant group difference in mean diastolic blood pressure reductions (P = 0.035): the hawthorn group showed greater reductions (baseline: 85.6 mmHg, 95% confidence interval [CI] = 83.3 to 87.8; outcome: 83.0 mmHg, 95% CI = 80.5 to 85.7) than the placebo group (baseline: 84.5 mmHg, 95% CI = 82 to 87; outcome: 85.0 mmHg, 95% CI = 82.2 to 87.8). There was no group difference in systolic blood pressure reduction from baseline (3.6 and 0.8 mmHg for hawthorn and placebo groups, respectively; P = 0.329). Although mean fat intake met current recommendations, mean sugar intake was higher and there were indications of potential multiple micronutrient deficiencies. No herb-drug interaction was found and minor health complaints were reduced from baseline in both groups. This is the first randomised controlled trial to demonstrate a hypotensive effect of hawthorn in patients with diabetes taking medication.

  17. A randomised controlled trial evaluating family mediated exercise (FAME therapy following stroke

    Directory of Open Access Journals (Sweden)

    Stokes Emma

    2008-06-01

    Full Text Available Abstract Background Stroke is a leading cause of disability among adults worldwide. Evidence suggests that increased duration of exercise therapy following stroke has a positive impact on functional outcome following stroke. The main objective of this randomised controlled trial is to evaluate the impact of additional family assisted exercise therapy in people with acute stroke. Methods/Design A prospective multi-centre single blind randomised controlled trial will be conducted. Forty patients with acute stroke will be randomised into either an experimental or control group. The experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The control group will receive routine therapy with no additional formal input from their family members. Participants will be assessed at baseline, post intervention and followed up at three months using a series of standardised outcome measures. A secondary aim of the project is to evaluate the impact of the family mediated exercise programme on the person with stroke and the individual(s assisting in the delivery of exercises using a qualitative methodology. The study has gained ethical approval from the Research Ethics Committees of each of the clinical sites involved in the study. Discussion This study will evaluate a structured programme of exercises that can be delivered to people with stroke by their 'family members/friends'. Given that the progressive increase in the population of older people is likely to lead to an increased prevalence of stroke in the future, it is important to reduce the burden of this illness on the individual, the family and society. Family mediated exercises can maximise the carry over outside formal physiotherapy sessions, giving patients the opportunity for informal practice. Trial Registration The protocol for this study is registered with the US NIH Clinical trials registry (NCT00666744

  18. Long term follow-up of a randomised controlled trial of services for urinary symptoms

    Directory of Open Access Journals (Sweden)

    Cooper Nicola J

    2011-03-01

    Full Text Available Abstract Background Given the extent and priority of urinary symptoms there is little evidence available to inform service provision in relation to the long term effects of interventions. This study aims to determine the long term (6 year clinical effectiveness and costs of a new continence nurse led service compared to standard care for urinary symptoms. Methods A long term follow-up study of a 2-arm, non-blinded randomised controlled trial that recruited from a community based population between 1998-2000 in Leicestershire and Rutland UK was undertaken. 3746 men and women aged 40 years and over were followed up from the original trial. The continence nurse practitioner (CNP intervention comprised a continence service provided by specially trained nurses delivering evidence-based interventions using pre-determined care pathways. The standard care (SC arm comprised access to existing primary care including General Practitioner and continence advisory services in the area. Primary outcome: Improvement in one or more symptom. Secondary outcomes included: a Leicester Impact scale; b patient perception of problem; c number of symptoms alleviated and cost-effectiveness; all were recorded at long term follow-up (average 6 years post-randomisation. Results Overall at long-term follow-up (average 6 years significantly more individuals in the CNP group (72% had improved (i.e had fewer symptoms compared to those in the SC group (67% (difference of 5% 95% (CI = 0.6 to 9;p = 0.02. Conclusion The differences in outcome between the two randomised groups shown immediately post treatment had decreased by half in terms of symptom improvement at long term follow-up. Although the difference was statistically significant, the clinical significance may not be, although the direction of the difference favoured the new CNP service.

  19. Graduated compression stockings to treat acute leg pain associated with proximal DVT. A randomised controlled trial.

    Science.gov (United States)

    Kahn, S R; Shapiro, S; Ducruet, T; Wells, P S; Rodger, M A; Kovacs, M J; Anderson, D; Tagalakis, V; Morrison, D R; Solymoss, S; Miron, M-J; Yeo, E; Smith, R; Schulman, S; Kassis, J; Kearon, C; Chagnon, I; Wong, T; Demers, C; Hanmiah, R; Kaatz, S; Selby, R; Rathbun, S; Desmarais, S; Opatrny, L; Ortel, T L; Galanaud, J-P; Ginsberg, J S

    2014-12-01

    Acute deep venous thrombosis (DVT) causes leg pain. Elastic compression stockings (ECS) have potential to relieve DVT-related leg pain by diminishing the diameter of distended veins and increasing venous blood flow. It was our objective to determine whether ECS reduce leg pain in patients with acute DVT. We performed a secondary analysis of the SOX Trial, a multicentre randomised placebo controlled trial of active ECS versus placebo ECS to prevent the post-thrombotic syndrome.The study was performed in 24 hospital centres in Canada and the U.S. and included 803 patients with a first episode of acute proximal DVT. Patients were randomised to receive active ECS (knee length, 30-40 mm Hg graduated pressure) or placebo ECS (manufactured to look identical to active ECS, but lacking therapeutic compression). Study outcome was leg pain severity assessed on an 11-point numerical pain rating scale (0, no pain; 10, worst possible pain) at baseline, 14, 30 and 60 days after randomisation. Mean age was 55 years and 60% were male. In active ECS patients (n=409), mean (SD) pain severity at baseline and at 60 days were 5.18 (3.29) and 1.39 (2.19), respectively, and in placebo ECS patients (n=394) were 5.38 (3.29) and 1.13 (1.86), respectively. There were no significant differences in pain scores between groups at any assessment point, and no evidence for subgroup interaction by age, sex or anatomical extent of DVT. Results were similar in an analysis restricted to patients who reported wearing stockings every day. In conclusion, ECS do not reduce leg pain in patients with acute proximal DVT.

  20. Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Rosenberg Jacob

    2011-08-01

    Full Text Available Abstract Background Perforated diverticulitis is a condition associated with substantial morbidity. Recently published reports suggest that laparoscopic lavage has fewer complications and shorter hospital stay. So far no randomised study has published any results. Methods DILALA is a Scandinavian, randomised trial, comparing laparoscopic lavage (LL to the traditional Hartmann's Procedure (HP. Primary endpoint is the number of re-operations within 12 months. Secondary endpoints consist of mortality, quality of life (QoL, re-admission, health economy assessment and permanent stoma. Patients are included when surgery is required. A laparoscopy is performed and if Hinchey grade III is diagnosed the patient is included and randomised 1:1, to either LL or HP. Patients undergoing LL receive > 3L of saline intraperitoneally, placement of pelvic drain and continued antibiotics. Follow-up is scheduled 6-12 weeks, 6 months and 12 months. A QoL-form is filled out on discharge, 6- and 12 months. Inclusion is set to 80 patients (40+40. Discussion HP is associated with a high rate of complication. Not only does the primary operation entail complications, but also subsequent surgery is associated with a high morbidity. Thus the combined risk of treatment for the patient is high. The aim of the DILALA trial is to evaluate if laparoscopic lavage is a safe, minimally invasive method for patients with perforated diverticulitis Hinchey grade III, resulting in fewer re-operations, decreased morbidity, mortality, costs and increased quality of life. Trial registration British registry (ISRCTN for clinical trials ISRCTN82208287http://www.controlled-trials.com/ISRCTN82208287

  1. Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial

    Science.gov (United States)

    Mengoni, Silvana E; Gates, Bob; Parkes, Georgina; Wellsted, David; Barton, Garry; Ring, Howard; Khoo, Mary Ellen; Monji-Patel, Deela; Friedli, Karin; Zia, Asif; Irvine, Lisa; Durand, Marie-Anne

    2016-01-01

    Objective To investigate the feasibility of a full-scale randomised controlled trial of a picture booklet to improve quality of life for people with epilepsy and learning disabilities. Trial design A randomised controlled feasibility trial. Randomisation was not blinded and was conducted using a centralised secure database and a blocked 1:1 allocation ratio. Setting Epilepsy clinics in 1 English National Health Service (NHS) Trust. Participants Patients with learning disabilities and epilepsy who had: a seizure within the past 12 months, meaningful communication and a carer with sufficient proficiency in English. Intervention Participants in the intervention group used a picture booklet with a trained researcher, and a carer present. These participants kept the booklet, and were asked to use it at least twice more over 20 weeks. The control group received treatment as usual, and were provided with a booklet at the end of the study. Outcome measures 7 feasibility criteria were used relating to recruitment, data collection, attrition, potential effect on epilepsy-related quality of life (Epilepsy and Learning Disabilities Quality of Life Scale, ELDQOL) at 4-week, 12-week and 20-week follow-ups, feasibility of methodology, acceptability of the intervention and potential to calculate cost-effectiveness. Outcome The recruitment rate of eligible patients was 34% and the target of 40 participants was reached. There was minimal missing data and attrition. An intention-to-treat analysis was performed; data from the outcome measures suggest a benefit from the intervention on the ELDQOL behaviour and mood subscales at 4 and 20 weeks follow-up. The booklet and study methods were positively received, and no adverse events were reported. There was a positive indication of the potential for a cost-effectiveness analysis. Conclusions All feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial. Trial registration number ISRCTN

  2. Quality of reporting of clinical non-inferiority and equivalence randomised trials - update and extension

    Directory of Open Access Journals (Sweden)

    Schiller Petra

    2012-11-01

    Full Text Available Abstract Background Non-inferiority and equivalence trials require tailored methodology and therefore adequate conduct and reporting is an ambitious task. The aim of our review was to assess whether the criteria recommended by the CONSORT extension were followed. Methods We searched the Medline database and the Cochrane Central Register for reports of randomised non-inferiority and equivalence trials published in English language. We excluded reports on bioequivalence studies, reports targeting on other than the main results of a trial, and articles of which the full-text version was not available. In total, we identified 209 reports (167 non-inferiority, 42 equivalence trials and assessed the reporting and methodological quality using abstracted items of the CONSORT extension. Results Half of the articles did not report on the method of randomisation and only a third of the trials were reported to use blinding. The non-inferiority or equivalence margin was defined in most reports (94%, but was justified only for a quarter of the trials. Sample size calculation was reported for a proportion of 90%, but the margin was taken into account in only 78% of the trials reported. Both intention-to-treat and per-protocol analysis were presented in less than half of the reports. When reporting the results, a confidence interval was given for 85% trials. A proportion of 21% of the reports presented a conclusion that was wrong or incomprehensible. Overall, we found a substantial lack of quality in reporting and conduct. The need to improve also applied to aspects generally recommended for randomised trials. The quality was partly better in high-impact journals as compared to others. Conclusions There are still important deficiencies in the reporting on the methodological approach as well as on results and interpretation even in high-impact journals. It seems to take more than guidelines to improve conduct and reporting of non-inferiority and equivalence

  3. SMART: Self-Management of Anticoagulation, a Randomised Trial [ISRCTN19313375

    Directory of Open Access Journals (Sweden)

    Murray Ellen T

    2003-09-01

    Full Text Available Abstract Background Oral anticoagulation monitoring has traditionally taken place in secondary care because of the need for a laboratory blood test, the international normalised ratio (INR. The development of reliable near patient testing (NPT systems for INR estimation has facilitated devolution of testing to primary care. Patient self-management is a logical progression from the primary care model. This study will be the first to randomise non-selected patients in primary care, to either self-management or standard care. Method The study was a multi-centred randomised controlled trial with patients from 49 general practices recruited. Those suitable for inclusion were aged 18 or over, with a long term indication for oral anticoagulation, who had taken warfarin for at least six months. Patients randomised to the intervention arm attended at least two training sessions which were practice-based, 1 week apart. Each patient was assessed on their capability to undertake self management. If considered capable, they were given a near patient INR testing monitor, test strips and quality control material for home testing. Patients managed their own anticoagulation for a period of 12 months and performed their INR test every 2 weeks. Control patients continued with their pre-study care either attending hospital or practice based anticoagulant clinics. Discussion The methodology used in this trial will overcome concerns from previous trials of selection bias and relevance to the UK health service. The study will give a clearer understanding of the benefits of self-management in terms of clinical and cost effectiveness and patient preference.

  4. The Home-Based Older People's Exercise (HOPE trial: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Forster Anne

    2011-06-01

    Full Text Available Abstract Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE trial is a two arm, assessor blind pilot randomised controlled trial (RCT to assess the effectiveness of a 12 week exercise intervention (the HOPE programme designed to improve the mobility and functional abilities of frail older people living at home, compared with usual care. The primary outcome is the timed-up-and-go test (TUGT, measured at baseline and 14 weeks post-randomisation. Secondary outcomes include the Barthel Index of activities of daily living (ADL, EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D quality of life measure and the geriatric depression scale (GDS, measured at baseline and 14 weeks post-randomisation. We will record baseline frailty using the Edmonton Frail Scale (EFS, record falls and document muscle/joint pain. We will test the feasibility of collection of data to identify therapy resources required for delivery of the intervention. Discussion The HOPE trial will explore and evaluate a home-based exercise intervention for frail older people. Although previous RCTs have used operationalised, non-validated methods of measuring frailty, the HOPE trial is, to our knowledge, the first RCT of an exercise intervention for frail older people that includes a validated method of frailty assessment at baseline. Trial registration ISRCTN: ISRCTN57066881

  5. Effectiveness of customised foot orthoses for Achilles tendinopathy: a randomised controlled trial.

    Science.gov (United States)

    Munteanu, Shannon E; Scott, Lisa A; Bonanno, Daniel R; Landorf, Karl B; Pizzari, Tania; Cook, Jill L; Menz, Hylton B

    2015-08-01

    To evaluate the effectiveness of customised foot orthoses in chronic mid-portion Achilles tendinopathy. This was a participant-blinded, parallel-group randomised controlled trial at a single centre (La Trobe University, Melbourne, Australia). One hundred and forty participants aged 18-55 years with mid-portion Achilles tendinopathy were randomised to receive eccentric calf muscle exercises with either customised foot orthoses (intervention group) or sham foot orthoses (control group). Allocation to intervention was concealed. The Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire was completed at baseline, then at 1, 3, 6 and 12 months, with 3 months being the primary end point. Differences between groups were analysed using intention to treat with analysis of covariance. After randomisation into the customised foot orthoses group (n=67) or sham foot orthoses group (n=73), there was 70.7% follow-up of participants at 3 months. There were no significant differences between groups at any time point. At 3 months, the mean (SD) VISA-A score was 82.1 (16.3) and 79.2 (20.0) points for the customised and sham foot orthosis groups, respectively (adjusted mean difference (95% CI)=2.6 (-2.9 to 8.0), p=0.353). There were no clinically meaningful differences between groups in any of the secondary outcome measures. Customised foot orthoses, prescribed according to the protocol in this study, are no more effective than sham foot orthoses for reducing symptoms and improving function in people with mid-portion Achilles tendinopathy undergoing an eccentric calf muscle exercise programme. Australian New Zealand Clinical Trials Registry: number ACTRN12609000829213. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  6. Pragmatic randomised controlled trial of group psychoeducation versus group support in the maintenance of bipolar disorder

    Directory of Open Access Journals (Sweden)

    Roberts Christopher

    2011-07-01

    Full Text Available Abstract Background Non-didactically delivered curriculum based group psychoeducation has been shown to be more effective than both group support in a specialist mood disorder centre in Spain (with effects lasting up to five years, and treatment as usual in Australia. It is unclear whether the specific content and form of group psychoeducation is effective or the chance to meet and work collaboratively with other peers. The main objective of this trial is to determine whether curriculum based group psychoeducation is more clinically and cost effective than unstructured peer group support. Methods/design Single blind two centre cluster randomised controlled trial of 21 sessions group psychoeducation versus 21 sessions group peer support in adults with bipolar 1 or 2 disorder, not in current episode but relapsed in the previous two years. Individual randomisation is to either group at each site. The groups are carefully matched for the number and type of therapists, length and frequency of the interventions and overall aim of the groups but differ in content and style of delivery. The primary outcome is time to next bipolar episode with measures of the therapeutic process, barriers and drivers to the effective delivery of the interventions and economic analysis. Follow up is for 96 weeks after randomisation. Discussion The trial has features of both an efficacy and an effectiveness trial design. For generalisability in England it is set in routine public mental health practice with a high degree of expert patient involvement. Trial Registration ISRCTN62761948 Funding National Institute for Health Research, England.

  7. Randomised controlled trials of veterinary homeopathy: characterising the peer-reviewed research literature for systematic review.

    Science.gov (United States)

    Mathie, Robert T; Hacke, Daniela; Clausen, Jürgen

    2012-10-01

    Systematic review of the research evidence in veterinary homeopathy has never previously been carried out. This paper presents the search methods, together with categorised lists of retrieved records, that enable us to identify the literature that is acceptable for future systematic review of randomised controlled trials (RCTs) in veterinary homeopathy. All randomised and controlled trials of homeopathic intervention (prophylaxis and/or treatment of disease, in any species except man) were appraised according to pre-specified criteria. The following databases were systematically searched from their inception up to and including March 2011: AMED; Carstens-Stiftung Homeopathic Veterinary Clinical Research (HomVetCR) database; CINAHL; Cochrane Central Register of Controlled Trials; Embase; Hom-Inform; LILACS; PubMed; Science Citation Index; Scopus. One hundred and fifty records were retrieved; 38 satisfied the acceptance criteria (substantive report of a clinical treatment or prophylaxis trial in veterinary homeopathic medicine randomised and controlled and published in a peer-reviewed journal), and were thus eligible for future planned systematic review. Approximately half of the rejected records were theses. Seven species and 27 different species-specific medical conditions were represented in the 38 papers. Similar numbers of papers reported trials of treatment and prophylaxis (n=21 and n=17 respectively) and were controlled against placebo or other than placebo (n=18, n=20 respectively). Most research focused on non-individualised homeopathy (n=35 papers) compared with individualised homeopathy (n=3). The results provide a complete and clarified view of the RCT literature in veterinary homeopathy. We will systematically review the 38 substantive peer-reviewed journal articles under the main headings: treatment trials; prophylaxis trials. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  8. Educational outreach to general practitioners reduces children's asthma symptoms: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sladden Michael

    2007-09-01

    Full Text Available Abstract Background Childhood asthma is common in Cape Town, a province of South Africa, but is underdiagnosed by general practitioners. Medications are often prescribed inappropriately, and care is episodic. The objective of this study is to assess the impact of educational outreach to general practitioners on asthma symptoms of children in their practice. Methods This is a cluster randomised trial with general practices as the unit of intervention, randomisation, and analysis. The setting is Mitchells Plain (population 300,000, a dormitory town near Cape Town. Solo general practitioners, without nurse support, operate from storefront practices. Caregiver-reported symptom data were collected for 318 eligible children (2 to 17 years with moderate to severe asthma, who were attending general practitioners in Mitchells Plain. One year post-intervention follow-up data were collected for 271 (85% of these children in all 43 practices. Practices randomised to intervention (21 received two 30-minute educational outreach visits by a trained pharmacist who left materials describing key interventions to improve asthma care. Intervention and control practices received the national childhood asthma guideline. Asthma severity was measured in a parent-completed survey administered through schools using a symptom frequency and severity scale. We compared intervention and control group children on the change in score from pre-to one-year post-intervention. Results Symptom scores declined an additional 0.84 points in the intervention vs. control group (on a nine-point scale. p = 0.03. For every 12 children with asthma exposed to a doctor allocated to the intervention, one extra child will have substantially reduced symptoms. Conclusion Educational outreach was accepted by general practitioners and was effective. It could be applied to other health care quality problems in this setting.

  9. Professional kinesiology practice for chronic low back pain: single-blind, randomised controlled pilot study.

    Science.gov (United States)

    Eardley, S; Brien, S; Little, P; Prescott, P; Lewith, G

    2013-01-01

    Chronic low back pain is a highly prevalent condition with no definitive treatment. Professional Kinesiology Practice (PKP) is a little known complementary medicine technique using non-standard muscle testing; no previous effectiveness studies have been performed. This is an exploratory, pragmatic single-blind, 3-arm randomised sham-controlled pilot study with waiting list control (WLC) in private practice UK (2007-2009). 70 participants scoring ≥4 on the Roland and Morris Disability Questionnaire (RMDQ) were randomised to real or sham PKP receiving 1 treatment weekly for 5 weeks or a WLC. WLC's were re-randomised to real or sham after 6 weeks. The main outcome was a change in RMDQ from baseline to end of 5 weeks of real or sham PKP. With an effect size of 0.7 real treatment was significantly different to sham (mean difference RMDQ score = -2.9, p = 0.04, 95% CI -5.8 to -0.1). Compared to WLC, real and sham groups had significant RMDQ improvements (real -9.0, p < 0.01, 95% CI -12.1 to -5.8; effect size 2.1; sham -6.1, p < 0.01, 95% CI -9.1 to -3.1; effect size 1.4). Practitioner empathy (CARE) and patient enablement (PEI) did not predict outcome; holistic health beliefs (CAMBI) did, though. The sham treatment appeared credible; patients did not guess treatment allocation. 3 patients reported minor adverse reactions. Real treatment was significantly different from sham demonstrating a moderate specific effect of PKP; both were better than WLC indicating a substantial non-specific and contextual treatment effect. A larger definitive study would be appropriate with nested qualitative work to help understand the mechanisms involved in PKP.

  10. Evaluation on Effects of Donor Heart Preservation for On-Pump Beating-Heart Transplantation%体外循环下不停跳供心保存植入的效果评价▲

    Institute of Scientific and Technical Information of China (English)

    朱蔚琳; 黄爱兰; 胡彦艳; 温红; 林辉; 莫安胜

    2013-01-01

    Objective To study the effects of donor heart preserved with continuous on-pump beating-heart warm-blood perfusion and University of Wisconsin (UW) solution on hemodynamics and cardiac function after transplantation in pigs.Methods Twenty-four Bama miniature pigs were randomly divided into two groups:In beating-heart group (n=12),donor hearts were stored by on-pump perfusion with warm blood;In cold UW storage group (n=12),donor hearts were stored in cold UW solution .There were six pigs for donors and six for recipients in each group .Donor hearts were stored for 8 hours after isolation,and then were implanted into recipient pigs by orthotopic heart transplantation . Automatically rebeating of implanted heart and the frequency of defibrillation in both groups were recorded two hours after the aortic cross-clamp released,left and right ventricular function were measured as well .The changes of hemodynamics were observed 30 minutes after cardiopulmonary bypass.Results After being implanted into recipient pigs,6 donor hearts recovered automatic-beating 3 minutes after the aortic cross-clamp released in the beating-heart group;All of 6 donor hearts did not recovered automatic-beating in the cold UW storage group,and the frequency of defibrillation accounted for 12;Significant difference was found in the automatically rebeating rate of implanted heart between two groups (P<0.05).Two hours after the aortic cross-clamp released,left and right ventricular systolic pressure in the beating-heart group were significantly better than those in the cold UW storage group (all P<0.05);Thirty minutes after cardiopulmonary bypass, central venous pressure (CVP) and pulmonary capillary wedge pressure (PCWP) in the beating-heart group were significantly lower than those in the cold UW storage group (all P<0.05);Cardiac output(CO) and cardiac index(CI) in the beating-heart group were significantly higher than those in the cold UW storage group (P<0.05),and the dosages of dopamine and

  11. Myocardial protection during off pump coronary artery bypass surgery: A comparison of inhalational anesthesia with sevoflurane or desflurane and total intravenous anesthesia

    Directory of Open Access Journals (Sweden)

    Sharadaprasad Suryaprakash

    2013-01-01

    Full Text Available Aims and Objectives: The objective of the study was to evaluate the myocardial protective effect of volatile agents-sevoflurane and desflurane versus total intravenous anesthesia (TIVA with propofol in offpump coronary artery bypass surgery (OPCAB by measuring cardiac troponin-T (cTnT as a marker of myocardial cell death. Materials and Methods: The study was conducted on 139 patients scheduled to undergo elective OPCAB surgery. The patients were randomly allocated to receive anesthesia with sevoflurane, desflurane or TIVA with propofol. The cTnT levels were measured preoperatively, at arrival in postoperative intensive care unit, at 8, 24, 48 and 96 hours thereafter. Results: The changes in cTnT levels at all time intervals were comparable in the three groups. Conclusion: The study did not reveal any difference in myocardial protection after OPCAB with either sevoflurane or desflurane or TIVA using propofol as assessed by measuring serial cTnT values.

  12. Relation of Mitochondrial DNA Copy Number in Peripheral Blood to Postoperative Atrial Fibrillation After Isolated Off-Pump Coronary Artery Bypass Grafting.

    Science.gov (United States)

    Zhang, Jian; Xu, Shu; Xu, Yinli; Liu, Yu; Li, Zhi; Zhang, Yuji; Jin, Yan; Xue, Xiaodong; Wang, Huishan

    2017-02-01

    Oxidative stress has been considered to be an important factor contributing to postoperative atrial fibrillation (PoAF). Mitochondrial DNA (mtDNA) copy number in peripheral blood has been found to be associated with a patient's oxidative stress. Therefore, we sought to determine whether there was association between mtDNA copy number and the onset of atrial fibrillation. mtDNA copy numbers were measured using the quantitative real-time polymerase chain reaction in peripheral blood from 485 consecutive patients with sinus rhythm undergoing coronary artery bypass grafting. The blood was collected before surgery. In the cohort, the incidence of PoAF was 20.8% (101/485). The mean mtDNA copy number was significantly higher in patents with PoAF than in those with sinus rhythm (36.43 vs 16.63, p copy number could predict PoAF with good sensitivity and specificity (area under the curve = 0.814, cutoff = 20.91, sensitivity = 70.3%, specificity = 80.2%, p copy number was shown to be a significant independent risk factor for PoAF (odds ratio = 10.01, p copy number and malondialdehyde in patients with PoAF (r = 0.449, p = 0.01). In conclusion, we showed that elevated mtDNA copy number in peripheral blood is associated with PoAF. Further investigation is needed to validate mtDNA copy number as a predictive biomarker for PoAF and to explore its potential role in arrhythmogenesis. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Right thoracotomy approach for repair of recurrent or complex coarctation of the aorta using an extra-anatomic ascending aorta to descending aorta bypass graft off-pump.

    Science.gov (United States)

    Tabry, Imad F; Zachariah, Zachariah P

    2013-01-01

    A previously described but rarely used surgical technique for the repair of complex or recurrent coarctation of the aorta through a right thoracotomy approach is presented in detail. It has the advantages of being simple and avoiding left chest re-entry, median sternotomy and cardiopulmonary bypass altogether.

  14. A comparative study of oral tapentadol with thoracic epidural analgesia versus intravenous tramadol and paracetamol combination for postoperative analgesia in off pump CABG

    Directory of Open Access Journals (Sweden)

    Himanshu A. Shah

    2013-12-01

    Conclusions: Our study concludes that Tapentadol with Thoracic epidural is very much effective as a multimodal analgesia approach in controlling acute postoperative pain after CABG. Tapentadol is quite a newer drug so its usefulness for other patients and different surgeries is still to be debated. [Int J Basic Clin Pharmacol 2013; 2(6.000: 723-727

  15. Implementation of physical coordination training and cognitive behavioural training interventions at cleaning workplaces - secondary analyses of a randomised controlled trial

    DEFF Research Database (Denmark)

    Jørgensen, Marie B; Faber, Anne; Jespersen, Tobias;

    2012-01-01

    This study evaluates the implementation of physical coordination training (PCT) and cognitive behavioural training (CBTr) interventions in a randomised controlled trial at nine cleaners' workplaces. Female cleaners (n = 294) were randomised into a PCT, a CBTr or a reference (REF) group. Both 12-w....... However, thorough consideration should be given to feasibility in the design of interventions. The optimal intervention should be tailored to closely match the implementation context and be robust and flexible to minimise susceptibility to changes in work organisation....

  16. Internet based self-help therapy versus waitlist control group for persons with anxiety disorders: A randomised feasibility study

    DEFF Research Database (Denmark)

    Fenger, Morten Munthe; Lindschou, Jane; Gluud, Christian

    ) FearFighter or B) waitlist control group. Participants are persons with a diagnosis of social phobia, agora phobia, phobia or panic disorder. The intervention with FearFighter is a nine step cognitive behavioural self-help therapy program delivered over the internet over nine weeks. Participants...... mental disorders, national authorities call for more evidence based on randomised clinical trials. Objective: To investigate if persons with an anxiety disorder treated in the IBT program FearFighter will improve and recover. Method: A randomised feasibility study with 64 participants allocated to A...

  17. Chinese herbal medicine for idiopathic sudden sensorineural hearing loss: a systematic review of randomised clinical trials.

    Science.gov (United States)

    Su, C-X; Yan, L-J; Lewith, G; Liu, J-P

    2013-12-01

    Idiopathic sudden sensorineural hearing loss has great impact on quality of life. Many clinical trials using Chinese herbal medicine for idiopathic sudden sensorineural hearing loss have been conducted and reported beneficial results. However, there is no critical appraised evidence on efficacy and safety of Chinese herbal medicine for idiopathic sudden sensorineural hearing loss to inform clinical use. To assess the beneficial effect and safety of Chinese herbal medicine for idiopathic sudden sensorineural hearing loss. Systematic review of randomised clinical trials. Seven electronic databases and two trial registries were searched for all eligible trials from inception to January 2013. Two authors independently selected trials and extracted data. The Cochrane risk of bias tool was utilised to assess the methodological quality of the included trials. revman 5.2 software was applied for data analysis with effect estimate presented as risk ratio and mean difference with its 95% confidence interval. Forty-one randomised clinical trials involving 3560 participants were identified. Five kinds of Chinese herbal medicine were trialed. All trials compared conventional therapies of steroids, vasodilators, anticoagulants, nutritional supplements or hyperbaric oxygen with or without herbal medicine. No trial was identified that compared herbal medicine alone with placebo. No trial was identified that blinded the participants or the observers to their herbal medication. Only one trial adequately reported its method of randomisation. No trial reported the sample size calculated to show an effect. All trials had material other defects giving a high likelihood of bias. Because of the overall poor quality of all 41 trials, it was concluded that there was no level-one evidence to support the use of Chinese herbal medicine, alone or in addition to conventional therapies, to improve the hearing in adults with idiopathic sudden sensorineural hearing loss. Two trials reported adverse

  18. The post hoc use of randomised controlled trials to explore drug associated cancer outcomes

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; Zoungas, Sophia; Chalmers, John

    2013-01-01

    INTRODUCTION: Drug-induced cancer risk is of increasing interest. Both observational studies and data from clinical trials have linked several widely used treatments to cancer. When a signal for a potential drug-cancer association is generated, substantiation is required to assess the impact...... on public health before proper regulatory action can be taken. This paper aims to discuss challenges of exploring drug-associated cancer outcomes by post-hoc analyses of Randomised controlled trials (RCTs) designed for other purposes. METHODOLOGICAL CHALLENGES TO CONSIDER: We set out to perform a post...

  19. Children, parents, and pets exercising together (CPET randomised controlled trial: study rationale, design, and methods

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    Yam Philippa S

    2012-03-01

    Full Text Available Abstract Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. Methods/design The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry; body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. Discussion The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical

  20. Effectiveness of group body psychotherapy for negative symptoms of schizophrenia: multicentre randomised controlled trial †

    OpenAIRE

    Priebe, S.; Savill, M.; Wykes, T.; Bentall, R P; Reininghaus, U; Lauber, C; Bremner, S; Eldridge, S; Röhricht, F.

    2016-01-01

    Background\\ud Negative symptoms of schizophrenia have a severe impact\\ud on functional outcomes and treatment options are limited.\\ud Arts therapies are currently recommended but more\\ud evidence is required.\\ud \\ud Aims\\ud To assess body psychotherapy as a treatment for negative\\ud symptoms compared with an active control (trial registration:ISRCTN84216587).\\ud \\ud Method\\ud Schizophrenia out-patients were randomised into a\\ud 20-session body psychotherapy or Pilates group. The primary\\ud ou...

  1. Timing of insertion of levonorgestrel-releasing intrauterine system: a randomised controlled trial.

    Science.gov (United States)

    van der Heijden, Pahh; Geomini, Pmaj; Herman, M C; Veersema, S; Bongers, M Y

    2017-01-01

    The objective was to assess whether patient-perceived pain during the insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) depends on the timing during the menstrual cycle. A stratified two-armed non-inferiority randomised controlled trial. Large teaching hospital in Veldhoven, the Netherlands. From October 2013 to May 2014, 60 nulliparous and 60 multiparous women were randomised. Eight women withdrew after randomisation and before insertion took place: therefore, data from 112 women were collected and analysed. Women were randomised to the groups 'during menstruation' (i.e. days 1-7 of menstruation) or 'outside menstruation' (i.e. any day of the cycle after menstruation without the presence of vaginal blood loss) in a ratio of 1 : 1. The primary outcome was pain during insertion, measured by the visual analogue scale (VAS, 0-100 mm). Second, we analysed ease of insertion, bleeding pattern, satisfaction, pregnancy, and expulsion rate. The follow-up time was 3 months. The mean VAS score for nulliparous women was 74 mm (95% confidence interval, 95% CI 67-81) in the 'during menstruation' group, compared with 66 mm (95% CI 59-74) in the 'outside menstruation' group (P = 0.14). The mean VAS score for multiparous women was 30 mm (95% CI 20-40) in the 'during menstruation group', compared with 43 mm (95% CI 32-53) in the 'outside menstruation' group (P = 0.08). There was no difference between the stratified 'during menstruation' group and the 'outside menstruation' group with regards to ease of insertion, satisfaction, bleeding pattern, and median spotting and bleeding days for the use of the LNG-IUS 3 months after insertion. As we did not find that the level of pain perceived during insertion was higher during menstruation, compared with outside menstruation, we conclude that the LNG-IUS can be inserted at any time during the menstrual cycle, especially in the case of nulliparous women. We conducted an RCT on time of insertion of

  2. A prospective randomised controlled trial of capnography vs. bronchoscopy for Blue Rhino percutaneous tracheostomy.

    Science.gov (United States)

    Mallick, A; Venkatanath, D; Elliot, S C; Hollins, T; Nanda Kumar, C G

    2003-09-01

    A crucial step for successful percutaneous tracheostomy is the introduction of the needle and guide wire into the trachea. Capnography has recently been proposed as one way to confirm tracheal needle placement. In this randomised controlled study, we used capnography in 26 patients and bronchoscopy in 29 patients to confirm needle placement for percutaneous tracheostomy using Blue Rhino kit. The operating times and the incidence of peri-operative complications were similar for both groups. Capnography proved to be as effective as bronchoscopy in confirming correct needle placement.

  3. Endoscopic versus open release in patients with de Quervain's tenosynovitis: a randomised trial.

    Science.gov (United States)

    Kang, H J; Koh, I H; Jang, J W; Choi, Y R

    2013-07-01

    The purpose of this study was to compare the outcome and complications of endoscopic versus open release for the treatment of de Quervain's tenosynovitis. Patients with this condition were randomised to undergo either endoscopic (n = 27) or open release (n = 25). Visual Analogue Scale (VAS) pain and Disabilities of Arm, Shoulder, and Hand (DASH) scores were measured at 12 and 24 weeks after surgery. Scar satisfaction was measured using a VAS scale. The mean pain and DASH scores improved significantly at 12 weeks and 24 weeks (p Quervain's tenosynovitis seems to provide earlier improvement after surgery, with fewer superficial radial nerve complications and greater scar satisfaction, when compared with open release.

  4. Lovastatin for adult patients with dengue: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Whitehorn James

    2012-10-01

    Full Text Available Abstract Background Dengue is the most important vector-borne viral infection of man, with approximately 2 billion people living in areas at risk. Infection results in a range of manifestations from asymptomatic infection through to life-threatening shock and haemorrhage. One of the hallmarks of severe dengue is vascular endothelial disruption. There is currently no specific therapy and clinical management is limited to supportive care. Statins are a class of drug initially developed for lipid lowering. There has been considerable recent interest in their effects beyond lipid lowering. These include anti-inflammatory effects at the endothelium. In addition, it is possible that lovastatin may have an anti-viral effect against dengue. Observational data suggest that the use of statins may improve outcomes for such conditions as sepsis and pneumonia. This paper describes the protocol for a randomised controlled trial investigating a short course of lovastatin therapy in adult patients with dengue. Methods/design A randomised, double-blind, placebo-controlled trial will investigate the effects of lovastatin therapy in the treatment of dengue. The trial will be conducted in two phases with an escalation of dose between phases if an interim safety review is satisfactory. This is an exploratory study focusing on safety and there are no data on which to base a sample size calculation. A target sample size of 300 patients in the second phase, enrolled over two dengue seasons, was chosen based on clinical judgement and feasibility considerations. In a previous randomised trial in dengue, about 10% and 30% of patients experienced at least one serious adverse event or adverse event, respectively. With 300 patients, we will have 80% power to detect an increase of 12% (from 10% to 22% or 16% (from 30% to 46% in the frequency of adverse events. Furthermore, this sample size ensures some power to explore the efficacy of statins. Discussion The development of a

  5. Acupuncture for chronic neck pain: a pilot for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Bland Martin J

    2006-12-01

    Full Text Available Abstract Background Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain. Methods Patients whose GPs had diagnosed neck pain were recruited from one general practice, and randomised to receive usual GP care only, or acupuncture (up to 10 treatments over 3 months as an adjunctive treatment to usual GP care. The primary outcome measure was the Northwick Park Neck Pain Questionnaire (NPQ at 3 months. The primary analysis was to determine the sample size for the full scale study. Results Of the 227 patients with neck pain identified from the GP database, 28 (12.3% consenting patients were eligible to participate in the pilot and 24 (10.5% were recruited to the trial. Ten patients were randomised to acupuncture, receiving an average of eight treatments from one of four acupuncturists, and 14 were randomised to usual GP care alone. The sample size for the full scale trial was calculated from a clinically meaningful difference of 5% on the NPQ and, from this pilot, an adjusted standard deviation of 15.3%. Assuming 90% power at the 5% significance level, a sample size of 229 would be required in each arm in a large-scale trial when allowing for a loss to follow-up rate of 14%. In order to achieve this sample, one would need to identify patients from databases of GP practices with a total population of 230,000 patients, or approximately 15 GP practices roughly equal in size to the one involved in this study (i.e. 15,694 patients. Conclusion This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence

  6. Randomised, double-blind, placebo-controlled study of pivagabine in neurasthenia.

    Science.gov (United States)

    Pizzolato, G; Cagnin, A; Mancia, D; Caffarra, P; Avanzi, S; Copelli, S; Ciappina, C; Lo Presti, F; Spilimbergo, P G; D'Antonio, E; Di Costanzo, E; Matrango, M; Pastres, P; Urbani, P P; Signorino, M; Simoncelli, M; Provinciali, L; Regnicolo, L; Albano, C; Roccatagliata, G; Rubino, V; Cultrera, S; Fracassi, M

    1997-11-01

    One hundred and eighteen patients with neurasthenia, as defined by ICD 10 (International Classification of Diseases), participated in a randomised, double-blind, placebo-controlled trial of pivagabine (4-[(2,2-dimethyl-1-oxopropyl)amino]butanoic acid, CAS 69542-93-4, Tonerg). Pivagabine 1800 mg/d was administered orally for four weeks. At the end of the trial, active medication was significantly superior to placebo on the Clinical Global Impression (CGI) improvement of illness scale. In addition, pivagabine treatment reduced the physical and mental fatigability of patients, and increased their sense of well-being.

  7. Randomised trial on episodic cluster headache with an angiotensin II receptor blocker

    DEFF Research Database (Denmark)

    Tronvik, Erling; Wienecke, Troels; Monstad, Inge

    2013-01-01

    OBJECTIVES: The aim of this study was to evaluate the angiotensin II receptor antagonist candesartan as prophylactic medication in patients with episodic cluster headache. METHODS: This study comprised a prospective, placebo-controlled, double-blind, parallel-designed trial performed in seven...... centres in Scandinavia. Forty (40) patients with episodic cluster headache (ICHD-2) were recruited and randomised over a five-year period to placebo or 16 mg candesartan in the first week, and placebo or 32 mg candesartan in the second and third week. RESULTS: The number of cluster headache attacks...

  8. The RESOLVE Trial for people with chronic low back pain: protocol for a randomised clinical trial.

    Science.gov (United States)

    Bagg, Matthew K; Hübscher, Markus; Rabey, Martin; Wand, Benedict M; O'Hagan, Edel; Moseley, G Lorimer; Stanton, Tasha R; Maher, Chris G; Goodall, Stephen; Saing, Sopany; O'Connell, Neil E; Luomajoki, Hannu; McAuley, James H

    2017-01-01

    Low back pain is the leading worldwide cause of disability, and results in significant personal hardship. Most available treatments, when tested in high-quality randomised, controlled trials, achieve only modest improvements in pain, at best. Recently, treatments that target central nervous system function have been developed and tested in small studies. Combining treatments that target central nervous system function with traditional treatments directed towards functioning of the back is a promising approach that has yet to be tested in adequately powered, prospectively registered, clinical trials. The RESOLVE trial will be the first high-quality assessment of two treatment programs that combine central nervous system-directed and traditional interventions in order to improve chronic low back pain. To compare the effectiveness of two treatment programs that combine central nervous system-directed and traditional interventions at reducing pain intensity at 18 weeks post randomisation in a randomised clinical trial of people with chronic low back pain. Two-group, randomised, clinical trial with blinding of participants and assessors. Two hundred and seventy-five participants with chronic low back pain that has persisted longer than 3 months and no specific spinal pathology will be recruited from the community and primary care in Sydney, Australia. Both of the interventions contain treatments that target central nervous system function combined with treatments directed towards functioning of the back. Adherence to the intervention will be monitored using an individual treatment diary and adverse events recorded through passive capture. Participants are informed prior to providing informed consent that some of the treatments are not active. Blinding is maintained by not disclosing any further information. Complete disclosure of the contents of the intervention has been made with the UNSW HREC (HC15357) and an embargoed project registration has been made on the Open

  9. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials (Chinese version)

    DEFF Research Database (Denmark)

    Moher, David; Hopewell, Sally; Schulz, Kenneth F;

    2010-01-01

    Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate...... that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed...

  10. Automation-assisted versus manual reading of cervical cytology (MAVARIC): a randomised controlled trial.

    Science.gov (United States)

    Kitchener, Henry C; Blanks, Roger; Dunn, Graham; Gunn, Lionel; Desai, Mina; Albrow, Rebecca; Mather, Jean; Rana, Durgesh N; Cubie, Heather; Moore, Catherine; Legood, Rosa; Gray, Alastair; Moss, Sue

    2011-01-01

    The standard for reading cervical cytology is for a cytoscreener to manually search across an entire slide for abnormal cells using a conventional microscope. Automated technology can select fields of view to assess abnormal cells, which allows targeted reading by cytoscreeners. In the Manual Assessment Versus Automated Reading In Cytology (MAVARIC) trial, we compared the accuracy of these techniques for the detection of underlying disease. For this randomised controlled trial, women aged 25-64 years undergoing primary cervical screening in Manchester, UK, were randomly assigned (1:2) to receive either manual reading only or paired reading (automation-assisted reading and manual reading), between March 1, 2006, and Feb 28, 2009. In the paired arm, two automated systems were used-the ThinPrep Imaging System and the FocalPoint GS Imaging System. General practices and community clinics were randomised to either ThinPrep or to SurePath (for the FocalPoint system) liquid-based cytology with block randomisation stratified by deprivation index. Samples were then individually randomised to manual reading only or paired reading only. Laboratory staff were unaware of the allocation of each slide and concealment was maintained until the end of the reporting process. The primary outcome was sensitivity of automation-assisted reading relative to manual reading for the detection of underlying cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in the paired arm. This trial is registered, number ISRCTN66377374. 73,266 liquid-based cytology samples were obtained from women undergoing primary cervical screening; 24,688 allocated to the manual-only arm and 48,578 to the paired-reading arm. Automation-assisted reading was 8% less sensitive than manual reading (relative sensitivity 0·92, 95% CI 0·89-0·95), which was equivalent to an absolute reduction in sensitivity of 6·3%, assuming the sensitivity of manual reading to be 79%. Specificity of automation-assisted reading

  11. Post-Operative Benefits of Animal-Assisted Therapy in Pediatric Surgery: A Randomised Study

    OpenAIRE

    Valeria Calcaterra; Pierangelo Veggiotti; Clara Palestrini; Valentina De Giorgis; Roberto Raschetti; Massimiliano Tumminelli; Simonetta Mencherini; Francesca Papotti; Catherine Klersy; Riccardo Albertini; Selene Ostuni; Gloria Pelizzo

    2015-01-01

    Background Interest in animal-assisted therapy has been fuelled by studies supporting the many health benefits. The purpose of this study was to better understand the impact of an animal-assisted therapy program on children response to stress and pain in the immediate post-surgical period. Patients and Methods Forty children (3–17 years) were enrolled in the randomised open-label, controlled, pilot study. Patients were randomly assigned to the animal-assisted therapy-group (n = 20, who underw...

  12. Participation bias in a randomised trial of screening for lung cancer

    DEFF Research Database (Denmark)

    Hestbech, Mie Sara; Siersma, Volkert; Dirksen, Asger

    2011-01-01

    INTRODUCTION: Participation bias might affect the results and the representability of randomised controlled trials. We investigated the degree of socio-demographic and psychosocial participation bias in the Danish Lung Cancer Screening Trial (DLCST). METHODS: In DLCST the questionnaire COS......-LC (Consequences of Screening in Lung Cancer) was used to measure the psychosocial aspects of screening. To investigate a difference with a comparable representative sample from the Danish population, we sent out an inclusion questionnaire to 3999 Danes in the age from 50 to 70 years randomly selected from...

  13. Advance care planning - a multi-centre cluster randomised clinical trial

    DEFF Research Database (Denmark)

    Rietjens, Judith A C; Korfage, Ida J; Dunleavy, Lesley

    2016-01-01

    BACKGROUND: Awareness of preferences regarding medical care should be a central component of the care of patients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable manner. Advance care planning (ACP) is a formalized process of communication between...... of their disease trajectory, is an important next step in an era of increased focus on patient centered healthcare and shared decision-making. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN63110516 . Date of registration: 10/3/2014....

  14. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Heliövaara, Arja; Küseler, Annelise; Skaare, Pål

    2017-01-01

    BACKGROUND AND AIM: Good dentofacial growth is a major goal in the treatment of unilateral cleft lip and palate (UCLP). The aim was to evaluate dental arch relationships at age 5 years after four different protocols of primary surgery for UCLP. DESIGN: Three parallel randomised clinical trials were...... undertaken as an international multi-centre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. METHODS: Three different surgical procedures for primary palatal repair (Arms B, C, D) were tested against a common procedure (Arm A) in the total cohort of 448 children born...

  15. Rapid versus standard intravenous rehydration in paediatric gastroenteritis: pragmatic blinded randomised clinical trial.

    Science.gov (United States)

    Freedman, Stephen B; Parkin, Patricia C; Willan, Andrew R; Schuh, Suzanne

    2011-11-17

    To determine if rapid rather than standard intravenous rehydration results in improved hydration and clinical outcomes when administered to children with gastroenteritis. Single centre, two arm, parallel randomised pragmatic controlled trial. Blocked randomisation stratified by site. Participants, caregivers, outcome assessors, investigators, and statisticians were blinded to the treatment assignment. Paediatric emergency department in a tertiary care centre in Toronto, Canada. 226 children aged 3 months to 11 years; complete follow-up was obtained on 223 (99%). Eligible children were aged over 90 days, had a diagnosis of dehydration secondary to gastroenteritis, had not responded to oral rehydration, and had been prescribed intravenous rehydration. Children were excluded if they weighed less than 5 kg or more than 33 kg, required fluid restriction, had a suspected surgical condition, or had an insurmountable language barrier. Children were also excluded if they had a history of a chronic systemic disease, abdominal surgery, bilious or bloody vomit, hypotension, or hypoglycaemia or hyperglycaemia. Rapid (60 mL/kg) or standard (20 mL/kg) rehydration with 0.9% saline over an hour; subsequent fluids administered according to protocol. clinical rehydration, assessed with a validated scale, two hours after the start of treatment. prolonged treatment, mean clinical dehydration scores over the four hour study period, time to discharge, repeat visits to emergency department, adequate oral intake, and physician's comfort with discharge. Data from all randomised patients were included in an intention to treat analysis. 114 patients were randomised to rapid rehydration and 112 to standard. One child was withdrawn because of severe hyponatraemia at baseline. There was no evidence of a difference between the rapid and standard rehydration groups in the proportions of participants who were rehydrated at two hours (41/114 (36%) v 33/112 (30%); difference 6.5% (95% confidence

  16. Effect of virtual reality training on laparoscopic surgery: randomised controlled trial

    DEFF Research Database (Denmark)

    2009-01-01

    OBJECTIVE: To assess the effect of virtual reality training on an actual laparoscopic operation. DESIGN: Prospective randomised controlled and blinded trial. SETTING: Seven gynaecological departments in the Zeeland region of Denmark. PARTICIPANTS: 24 first and second year registrars specialising...... in gynaecology and obstetrics. INTERVENTIONS: Proficiency based virtual reality simulator training in laparoscopic salpingectomy and standard clinical education (controls). MAIN OUTCOME MEASURE: The main outcome measure was technical performance assessed by two independent observers blinded to trainee......-14 minutes) and in the control group was 24 (20-29) minutes (Pvirtual reality simulator training. The performance level of novices...

  17. Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Alison Rushton

    Full Text Available To evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome; and efficient working of trial components.A feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012 was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres.Consecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy.Participants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone.Blinded assessments were made at 4 weeks post surgery (baseline and 12 weeks post baseline (proposed primary end point. Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation.At discharge, 110 (44% eligible patients gave consent to be contacted. 59 (54% patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD RMDQ was 10.07 (5.58 leaflet and 10.52 (5.94 physiotherapy/leaflet at baseline; and 5.37 (4.91 leaflet and 5.53 (4.49 physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD change -4.53 (6.41, 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59, 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI between change from baseline to twelve weeks was 1.65(-2.46 to 5.75. Mean difference (95%CI between groups at 12 weeks was -0.16 (-3.36 to 3.04. Participant adherence with treatment was good. No adverse events were reported.Both interventions were acceptable, and it is promising that they both demonstrated a trend in reducing disability in this population. A randomised controlled trial, using a

  18. Systematic review of randomised controlled trials:Probiotics for functional constipation

    Institute of Scientific and Technical Information of China (English)

    Anna; Chmielewska; Hania; Szajewska

    2010-01-01

    AIM:To systematically evaluate and update evidence on the efficacy and safety of probiotic supplementation for the treatment of constipation. METHODS:The MEDLINE,EMBASE,CINAHL,and Cochrane Library databases were searched in May 2009 for randomised controlled trials(RCTs)performed in paediatric or adult populations related to the study aim. RESULTS:We included five RCTs with a total of 377 subjects(194 in the experimental group and 183 in the control group).The participants were adults (three RCTs,n=266)and ...

  19. Randomised crossover trial of telemonitoring in chronic respiratory patients (TeleCRAFT trial).

    Science.gov (United States)

    Chatwin, M; Hawkins, G; Panicchia, L; Woods, A; Hanak, A; Lucas, R; Baker, E; Ramhamdany, E; Mann, B; Riley, J; Cowie, M R; Simonds, A K

    2016-04-01

    Randomised crossover trial with 6 months of standard best practice clinical care (control group) and 6 months with the addition of telemonitoring. 68 patients with chronic lung disease (38 with COPD; 30 with chronic respiratory failure due to other causes), who had a hospital admission for an exacerbation within 6 months of randomisation and either used long-term oxygen therapy or had an arterial oxygen saturation (SpO2) of telemonitoring (second-generation system) via broadband link to a hospital-based care team. Primary outcome measure was time to first hospital admission for an acute exacerbation. Secondary outcome measures were hospital admissions, general practitioner (GP) consultations and home visits by nurses, quality of life measured by EuroQol-5D and hospital anxiety and depression (HAD) scale, and self-efficacy score (Stanford). Median (IQR) number of days to first admission showed no difference between the two groups—77 (114) telemonitoring, 77.5 (61) control ( p=0.189). Hospital admission rate at 6 months increased (0.63 telemonitoring vs 0.32 control p=0.026). Home visits increased during telemonitoring; GP consultations were unchanged. Self-efficacy fell, while HAD depression score improved marginally during telemonitoring. Telemonitoring added to standard care did not alter time to next acute hospital admission, increased hospital admissions and home visits overall, and did not improve quality of life in chronic respiratory patients. NCT02180919 (ClinicalTrials.gov).

  20. A randomised controlled study of reflexology for the management of chronic low back pain.

    Science.gov (United States)

    Poole, Helen; Glenn, Sheila; Murphy, Peter

    2007-11-01

    The use of complementary and alternative medicine (CAM) for the management of chronic low back pain (CLBP) continues to rise. However, questions regarding the efficacy of many CAM therapies for CLBP remain unresolved. The present study investigated the effectiveness of reflexology for CLBP. A pragmatic randomised controlled trial was conducted. N=243 patients were randomised to one of three groups: reflexology, relaxation, or non-intervention (usual care). All completed a questionnaire booklet before and after the treatment phase, and at six months follow up. This measured their general health status, pain, functioning, coping strategies and mood. After adjusting for pre-treatment scores repeated measures ANCOVA found no significant differences between the groups pre and post treatment on the primary outcome measures of pain and functioning. There was a main effect of pain reduction, irrespective of group. Trends in the data illustrated the pain reduction was greatest in the reflexology group. Thus, the current study does not indicate that adding reflexology to usual GP care for the management of CLBP is any more effective than usual GP care alone.

  1. Physiological variation of retinal layer thickness is not caused by hydration: a randomised trial.

    Science.gov (United States)

    Balk, Lisanne J; Oberwahrenbrock, Timm; Uitdehaag, Bernard M J; Petzold, Axel

    2014-09-15

    There is evidence for physiological variation of retinal thicknesses as determined by optical coherence tomography (OCT). We tested if such changes could be explained by hydration and would exceed what may be expected from normal ageing. Subjects (n=26) of a previous study were re-assessed and were randomised to 3 groups of a hydration escalation trial (no hydration, 1× hydration, 2× hydration). Automated retinal layer segmentations were performed for the macular retinal nerve fibre layer (RNFL), ganglion cell layer (GCL), inner plexiform layer (IPL), inner nuclear layer (INL), outer plexiform layer (OPL) and outer nuclear layer (ONL). The averaged volumes were calculated for the central foveola, 3 mm and 6 mm circles of the ETDRS grid. Following oral hydration there were no significant differences of retinal layer thicknesses between the three randomised groups in any of the ETDRS regions at any time-point. Ageing related changes were significant over an 18 month period for the GCL. The negative outcome of this trial implies that, until the causes for the observed variation are resolved, investigators may need to accept, and include into trial power calculations, a small degree of variation (<1%) of quantitative SD-OCT imaging either due to human physiology or instrument/software related factors.

  2. Live lecture versus video podcast in undergraduate medical education: A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Fukuta Junaid

    2010-10-01

    Full Text Available Abstract Background Information technology is finding an increasing role in the training of medical students. We compared information recall and student experience and preference after live lectures and video podcasts in undergraduate medical education. Methods We performed a crossover randomised controlled trial. 100 students were randomised to live lecture or video podcast for one clinical topic. Live lectures were given by the same instructor as the narrator of the video podcasts. The video podcasts comprised Powerpoint™ slides narrated using the same script as the lecture. They were then switched to the other group for a second clinical topic. Knowledge was assessed using multiple choice questions and qualitative information was collected using a questionnaire. Results No significant difference was found on multiple choice questioning immediately after the session. The subjects enjoyed the convenience of the video podcast and the ability to stop, review and repeat it, but found it less engaging as a teaching method. They expressed a clear preference for the live lecture format. Conclusions We suggest that video podcasts are not ready to replace traditional teaching methods, but may have an important role in reinforcing learning and aiding revision.

  3. Live lecture versus video podcast in undergraduate medical education: A randomised controlled trial

    Science.gov (United States)

    2010-01-01

    Background Information technology is finding an increasing role in the training of medical students. We compared information recall and student experience and preference after live lectures and video podcasts in undergraduate medical education. Methods We performed a crossover randomised controlled trial. 100 students were randomised to live lecture or video podcast for one clinical topic. Live lectures were given by the same instructor as the narrator of the video podcasts. The video podcasts comprised Powerpoint™ slides narrated using the same script as the lecture. They were then switched to the other group for a second clinical topic. Knowledge was assessed using multiple choice questions and qualitative information was collected using a questionnaire. Results No significant difference was found on multiple choice questioning immediately after the session. The subjects enjoyed the convenience of the video podcast and the ability to stop, review and repeat it, but found it less engaging as a teaching method. They expressed a clear preference for the live lecture format. Conclusions We suggest that video podcasts are not ready to replace traditional teaching methods, but may have an important role in reinforcing learning and aiding revision. PMID:20932302

  4. A randomised controlled trial of group cognitive behavioural therapy for perfectionism.

    Science.gov (United States)

    Handley, Alicia K; Egan, Sarah J; Kane, Robert T; Rees, Clare S

    2015-05-01

    Perfectionism is associated with symptoms of anxiety disorders, eating disorders and mood disorders. Treatments targeting perfectionism may reduce the symptoms of these disorders (Egan, Wade, & Shafran, 2011). This study is the first randomised controlled trial to investigate the efficacy of group cognitive behavioural therapy (CBT) for perfectionism. Forty-two participants with elevated perfectionism and a range of anxiety, eating and mood disorders were randomised to group CBT for perfectionism or a waitlist control. The treatment group reported significantly greater pre-post reductions in perfectionism, symptoms of depression, eating disorders, social anxiety, anxiety sensitivity and rumination, as well as significantly greater pre-post increases in self-esteem and quality of life compared to the waitlist control group. The impact of treatment on most of these outcomes was mediated by pre-post change in perfectionism (Concern over Mistakes). Treatment gains were reliable and clinically significant, and were maintained at 6-month follow-up. Findings support group CBT for perfectionism being an efficacious treatment for perfectionism and related psychopathology, as well as increasing self-esteem and quality of life.

  5. Randomised clinical efficacy trial of potassium oxalate mouthrinse in relieving dentinal sensitivity.

    Science.gov (United States)

    Sharma, Deepak; McGuire, James A; Gallob, John T; Amini, Pejmon

    2013-07-01

    The study aimed to determine the efficacy in relieving dentinal sensitivity of 4 weeks' treatment with an alcohol-free mouthrinse comprising 1.4% potassium oxalate (KO) (Listerine® Advanced Defence Sensitive; LADS), compared with negative and positive controls. Subjects were randomised to one of three treatments: LADS mouthrinse - twice-daily toothbrushing with Crest® Cavity Protection Regular toothpaste, rinsing with water and then 10 mL LADS mouthrinse, followed by expectoration; negative control (twice-daily brushing with Crest Cavity Protection Regular toothpaste); or positive control (twice-daily brushing with Sensodyne® Original desensitising toothpaste). Dentine sensitivity was assessed at baseline and after 2 and 4 weeks by Yeaple probe (tactile pressure; patient-reported discomfort by visual analogue scale [VAS]), air blast (VAS) and global subjective sensitivity (VAS). Oral tolerance was monitored throughout the study. At 2 weeks, subjects treated with the positive control and LADS mouthrinse showed significant reductions (pSensodyne Original) significantly reduced sensitivity compared with the negative control (Crest toothpaste alone), thus validating the study. The LADS mouthrinse (1.4% KO mouthrinse) significantly reduced sensitivity compared with the negative control, suggesting that LADS mouthrinse was responsible for the clinical effect observed. The treatments were well tolerated. To our knowledge, this is the first randomised clinical study to demonstrate the efficacy of a KO-containing mouthrinse (LADS) in relieving dentinal sensitivity. Copyright © 2013 Elsevier Ltd. All rights reserved.

  6. A randomised trial of nutrient supplements to minimise psychological stress after a natural disaster.

    Science.gov (United States)

    Kaplan, Bonnie J; Rucklidge, Julia J; Romijn, Amy R; Dolph, Michael

    2015-08-30

    After devastating flooding in southern Alberta in June 2013, we attempted to replicate a New Zealand randomised trial that showed that micronutrient (minerals, vitamins) consumption after the earthquakes of 2010-11 resulted in improved mental health. Residents of southern Alberta were invited to participate in a study on the potential benefit of nutrient supplements following a natural disaster. Fifty-six adults aged 23-66 were randomised to receive a single nutrient (vitamin D, n=17), a few-nutrients formula (B-Complex, n=21), or a broad-spectrum mineral/vitamin formula (BSMV, n=18). Self-reported changes in depression, anxiety and stress were monitored for six weeks. Although all groups showed substantial decreases on all measures, those consuming the B-Complex and the BSMV formulas showed significantly greater improvement in stress and anxiety compared with those consuming the single nutrient, with large effect sizes (Cohen's d range 0.76-1.08). There were no group differences between those consuming the B-Complex and BSMV. The use of nutrient formulas with multiple minerals and/or vitamins to minimise stress associated with natural disasters is now supported by three studies. Further research should be carried out to evaluate the potential population benefit that might accrue if such formulas were distributed as a post-disaster public health measure. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  7. Randomised controlled trial of qigong in the treatment of mild essential hypertension.

    Science.gov (United States)

    Cheung, B M Y; Lo, J L F; Fong, D Y T; Chan, M Y; Wong, S H T; Wong, V C W; Lam, K S L; Lau, C P; Karlberg, J P E

    2005-09-01

    Exercise and relaxation decrease blood pressure. Qigong is a traditional Chinese exercise consisting of breathing and gentle movements. We conducted a randomised controlled trial to study the effect of Guolin qigong on blood pressure. In all, 88 patients with mild essential hypertension were recruited from the community and randomised to Goulin qigong or conventional exercise for 16 weeks. The main outcome measurements were blood pressure, health status (SF-36 scores), Beck Anxiety and Depression Inventory scores. In the qigong group, blood pressure decreased significantly from 146.3+/-7.8/93.0+/-4.1 mmHg at baseline to 135.5+/-10.0/87.1+/-7.7 mmHg at week 16. In the exercise group, blood pressure also decreased significantly from 140.9+/-10.9/93.1+/-3.5 mmHg to 129.7+/-11.1/86.0+/-7.0 mmHg. Heart rate, weight, BMI, waist circumference, total cholesterol, renin and 24 h urinary albumin excretion significantly decreased in both groups after 16 weeks. General health, bodily pain, social functioning and depression also improved in both groups. No significant differences between qigong and conventional exercise were found. In conclusion, Guolin qigong and conventional exercise have similar effects on blood pressure in patients with mild hypertension. While no additional benefits were identified, it is nevertheless an alternative to conventional exercise in the nondrug treatment of hypertension.

  8. Replicability of sight word training and phonics training in poor readers: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    G McArthur

    2015-05-01

    Full Text Available Given the importance of effective treatments for children with reading impairment, paired with growing concern about the lack of scientific replication in psychological science, the aim of this study was to replicate a quasi-randomised trial of sight word and phonics training using a randomised controlled trial (RCT design. One group of poor readers (N = 41 did 8 weeks of phonics training (i.e., phonological decoding and then 8 weeks of sight word training (i.e., whole-word recognition. A second group did the reverse order of training. Sight word and phonics training each had a large and significant valid treatment effect on trained irregular words and word reading fluency. In addition, combined sight word and phonics training had a moderate and significant valid treatment effect on nonword reading accuracy and fluency. These findings demonstrate the reliability of both phonics and sight word training in treating poor readers in an era where the importance of scientific reliability is under close scrutiny.

  9. Anteroposterior glide versus rotating platform low contact stress (LCS knee arthroplasty: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Wynn-Jones Charles

    2007-08-01

    Full Text Available Abstract Background Fifty thousand knee replacements are performed annually in the UK at an estimated cost of £150 million. Post-operative improvement depends on a number of factors including implant design and patient associated factors. To our knowledge there are no published study's comparing the results of AP glide and rotating platform designs of LCS knee arthroplasty. Therefore we feel that a study is required to investigate and compare the effects of two types of LCS total knee arthroplasty on joint proprioception and range of motion. Methods/Design Patients will be randomised to receive either a LCS AP glide or Rotating platform prosthesis. Clinical scores (Oxford knee score, American knee society score, EuroQol, range of motion and proprioception will be assessed prior to and at 3,6, 12 and 24 months after the operation. Proprioception will be assessed in terms of absolute error angle (mean difference between the target angle and the response angle. Knee angles will be measured in degrees using an electromagnetic tracking device, Polhemus 3Space Fastrak that detects positions of sensors placed on the test limb. Student's t-test will be used to compare the mean of two groups. Discussion Evidence is lacking concerning the best prosthesis to use for patients undergoing total knee replacement. This pragmatic randomised trial will test the null hypothesis that anteroposterior glide LCS knee arthroplasty does not result in better post operative knee motion and proprioception as compared to rotating platform LCS knee. Trial Registration ISRCTN52943804

  10. Transitional care for the highest risk patients: findings of a randomised control study

    Directory of Open Access Journals (Sweden)

    Kheng Hock Lee

    2015-10-01

    Full Text Available Background: Interventions to prevent readmissions of patients at highest risk have not been rigorously evaluated. We conducted a randomised controlled trial to determine if a post-discharge transitional care programme can reduce