A randomised controlled trial for the effect of preoperative physiotherapy in patients with an increased risk for the development of postoperative pulmonary complications after open-heart surgery

2013 ◽  
Author(s):  
H.J. Hulzebos
Keyword(s):  
Randomised Controlled Trial ◽  
Heart Surgery ◽  
Controlled Trial ◽  
Open Heart Surgery ◽  
Pulmonary Complications ◽  
Open Heart ◽  
Postoperative Pulmonary Complications ◽  
Increased Risk ◽  
Randomised Controlled

Effect of steroids on inflammatory markers and clinical parameters in congenital open heart surgery: a randomised controlled trial

2015 ◽  
Vol 26 (3) ◽  
pp. 506-515 ◽  
Author(s):  
Muhammad M. Amanullah ◽  
Mohammad Hamid ◽  
Hashim M. Hanif ◽  
Marium Muzaffar ◽  
Maria T. Siddiqui ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Interleukin 6 ◽  
Heart Surgery ◽  
Controlled Trial ◽  
Open Heart Surgery ◽  
Interleukin 10 ◽  
Clinical Parameters ◽  
Open Heart ◽  
Necrosis Factor Alpha ◽  
Randomised Controlled

AbstractBackgroundCardiopulmonary bypass is associated with systemic inflammatory response. Steroids suppress this response, although the therapeutic evidence remains controversial. We hypothesised that intravenous steroids in children undergoing open-heart surgery would decrease inflammation leading to better early post-operative outcomes. We conducted a randomised controlled trial to evaluate the trends in the levels of immunomodulators and their effects on clinical parameters.ObjectiveTo assess the effects of intravenous steroids on early post-operative inflammatory markers and clinical parameters in children undergoing open-heart surgery.Materials and methodsA randomised controlled trial involving 152 patients, from one month up to 18 years of age, who underwent open-heart surgery for congenital heart disease from April 2010–2012 was carried out. Patients were randomised and administered either three scheduled intravenous pulse doses of dexamethasone (1 mg/kg) or placebo. Blood samples were drawn at four time intervals and serum levels of inflammatory cytokines – Interleukin-6, 8, 10, 18, and tumour necrosis factor-alpha – were measured. Clinical parameters were also assessed.ResultsBlood cytokine levels were compared between the dexamethasone (n=65) and placebo (n=64) groups. Interleukin-6 levels were lower at 6 and 24 hours post-operatively (p<0.001), and Interleukin-10 levels were higher 6 hours post-operatively (p<0.001) in the steroid group. Interleukin-8, 18, and tumour necrosis factor-alpha levels did not differ between the groups at any time intervals. The clinical parameters were similar in both the groups.ConclusionDexamethasone caused quantitative suppression of Interleukin-6 and increased Interleukin-10 activation, contributing to reduced immunopathology, but it did not translate into clinical benefit in the short term.

scholarly journals Sugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Kate Leslie ◽  
Matthew T. V. Chan ◽  
Jai N. Darvall ◽  
Anurika P. De Silva ◽  
Sabine Braat ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Neuromuscular Blockade ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Pulmonary Complications ◽  
Trial Registration ◽  
Postoperative Pulmonary Complications ◽  
Link Type ◽  
Randomised Controlled ◽  
Intrathoracic Surgery

Abstract Background Sugammadex reduces residual neuromuscular blockade after anaesthesia, potentially preventing postoperative pulmonary complications. However, definitive evidence is lacking. We therefore conducted a feasibility and pilot trial for a large randomised controlled trial of sugammadex, neostigmine, and postoperative pulmonary complications. Methods Patients aged ≥40 years having elective or expedited abdominal or intrathoracic surgery were recruited in Australia and Hong Kong. Perioperative care was at the discretion of clinicians, except for the use of rocuronium and/or vecuronium for neuromuscular blockade and the randomised intervention (sugammadex or neostigmine) for reversal. Feasibility measurements included recruitment, crossover, acceptability, completeness, and workload. Trial coordinator feedback was systematically sought. Patient-reported quality of life was measured using the EQ-5D-5L score. The primary pilot outcome was the incidence of new pulmonary complications up to hospital discharge (or postoperative day 7 if still in hospital). Results Among 150 eligible patients, 120 consented to participate (recruitment rate 80%, 95% confidence interval [CI] 73 to 86%). The randomised intervention was administered without crossover to 115 of 117 patients who received reversal (98%, 95% CI 94 to 100%). The protocol was acceptable or highly acceptable to the anaesthetist in 108 of 116 cases (93%, 95% CI 87 to 97%; missing = 4). Four patients of the 120 patients were lost to follow-up at 3 months (3.3%, 95% CI 0.9 to 8.3%). Case report forms were complete at 3 months for all remaining patients. The median time to complete trial processes was 3.5 h (range 2.5–4.5 h). Trial coordinators reported no barriers to trial processes. Patients were aged 64 (standard deviation 11) years, 70 (58%) were male and 50 (42%) were female, and planned surgeries were thoracic (23 [19%]), upper abdominal (41 [34%]), and lower abdominal (56 [47%]). The primary outcome was observed in 5 (8.5%) of the 59 sugammadex patients and 5 (8.2%) of the 61 neostigmine patients (odds ratio 1.02, 95% CI 0.28 to 3.67). Conclusions A large international randomised controlled trial of sugammadex, neostigmine and postoperative pulmonary complications in adult patients having abdominal and intrathoracic surgery, including collection of cost-effectiveness evidence for Health Technology Appraisal, is feasible. Trial registration Prospectively registered at the Australian and New Zealand Clinical Trials Registry (ACTRN12620001313921) on December 7, 2020. www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380645&isReview=true.

scholarly journals Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine (The P- PERSoN Trial) – Pilot Data Following Early Termination of a Prospective, Blinded, Randomised Trial.

2021 ◽  
Author(s):  
Benjamin Luke Olesnicky ◽  
Matthew Doane ◽  
Clare Farrell ◽  
Greg Knoblanche ◽  
Anthony Delaney
Keyword(s):  
Randomised Controlled Trial ◽  
Ordinal Data ◽  
Neuromuscular Block ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Pulmonary Complications ◽  
Residual Paralysis ◽  
Postoperative Pulmonary Complications ◽  
Double Blind ◽  
Randomised Controlled

Abstract Background: Residual paralysis following anaesthesia is common and can lead to postoperative morbidity. While sugammadex has been shown to be effective in minimising residual paralysis, uncertainty exists as to whether its use reduces any associated morbidity. We designed this trial to determine if the use of sugammadex for the reversal of intraoperative aminosteroid neuromuscular blockade results in improvements in postoperative pulmonary complications, complications in the recovery unit, postoperative nausea and vomiting, and patient satisfaction, when compared to reversal with neostigmine. Methods: A prospective, double-blind, randomised controlled trial in adult patients admitted for surgical operations at two Australian hospitals between December 2018 and March 2019 was performed comparing the reversal of neuromuscular paralysis using sugammadex 2mg/kg versus neostigmine 50mcg/kg. Statistical analysis of continuous data was performed using two tailed t-tests, with categorical and ordinal data was assessed by Chi-squared analysis. Results: The trial was terminated due to a combination of resource constraints and the 2019 novel coronavirus disease (COVID-19) pandemic. Of 51 patients screened, 33 were eligible for participation and 30 subsequently recruited and randomised. All patients received the intended treatment allocated. Data for the primary outcome was obtained in all patients. There was no difference in the rates of postoperative pulmonary complications between the sugammadex and neostigmine groups (0% (0/19) vs 9% (1/11) RR 5.0 (95%CI 0.22-113) p=0.37. There was no difference in any of the secondary outcomes between the groups. Conclusions: The P-PERSoN trial showed no difference in post operative pulmonary complications between sugammadex and neostigmine based reversal of aminosteroid neuromuscular block, but was underpowered to show any difference due to early trial termination. The randomisation and data collection was feasible. We support the need for an adequately resourced and funded randomised controlled trial to address this important clinical question. Trial Registration: The P-PERSoN trial is registered at the Australian and New Zealand Trial Registry (www.anzctr.org.au) # ACTRN12616000063415 and The U.S. National Library of Medicine (www.ClinicalTrials.gov) #NCT02825576

scholarly journals Normothermic versus hypothermic cardiopulmonary bypass in low-risk paediatric heart surgery: a randomised controlled trial

Heart ◽  
2018 ◽  
Vol 105 (6) ◽  
pp. 455-464 ◽  
Author(s):  
Massimo Caputo ◽  
Katie Pike ◽  
Sarah Baos ◽  
Karen Sheehan ◽  
Kathleen Selway ◽  
...  
Keyword(s):  
Cardiopulmonary Bypass ◽  
Hospital Stay ◽  
Heart Surgery ◽  
Open Heart Surgery ◽  
Postoperative Hospital Stay ◽  
Low Risk ◽  
Open Heart ◽  
Intubation Time ◽  
Organ Systems ◽  
Randomised Controlled

ObjectiveTo compare normothermic (35°C–36°C) versus hypothermic (28°C) cardiopulmonary bypass (CPB) in paediatric patients undergoing open heart surgery to test the hypothesis that normothermic CPB perfusion maintains the functional integrity of major organ systems leading to faster recovery.MethodsTwo single-centre, randomised controlled trials (known as Thermic-1 and Thermic-2, respectively) were carried out to compare the effectiveness and acceptability of normothermic versus hypothermic CPB in children with congenital heart disease undergoing open heart surgery. In both studies, the co-primary clinical outcomes were duration of inotropic support, intubation time and postoperative hospital stay.ResultsIn total, 200 participants were recruited; 59 to the Thermic-1 study and 141 to the Thermic-2 study. 98 patients received normothermic CPB and 102 patients received hypothermic CPB. There were no significant differences between the treatment groups for any of the co-primary outcomes: inotrope duration HR=1.01, 95% CI (0.72 to 1.41); intubation time HR=1.14, 95% CI (0.86 to 1.51); postoperative hospital stay HR=1.06, 95% CI (0.80 to 1.40). Differences favouring normothermia were found in urea nitrogen at 2 days geometric mean ratio (GMR)=0.86 95% CI (0.77 to 0.97); serum creatinine at 3 days GMR=0.89, 95% CI (0.81 to 0.98); urinary albumin at 48 hours GMR=0.32, 95% CI (0.14 to 0.74) and neutrophil gelatinase-associated lipocalin at 4 hours GMR=0.47, 95% CI (0.22 to 1.02), but not at other postoperative time points.ConclusionsNormothermic CPB is as safe and effective as hypothermic CPB and can be routinely adopted as a perfusion strategy in low-risk infants and children undergoing open heart surgery.Trial registration numberISRCTN93129502.

scholarly journals Findings of a feasibility study of pre-operative pulmonary rehabilitation to reduce post-operative pulmonary complications in people with chronic obstructive pulmonary disease scheduled for major abdominal surgery

2019 ◽  
Author(s):  
Lucy L Marlow ◽  
Angeline HY Lee ◽  
Emma Hedley ◽  
Michael P Grocott ◽  
Michael C Steiner ◽  
...  
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Randomised Controlled Trial ◽  
Abdominal Surgery ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Pulmonary Complications ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Randomised Controlled ◽  
Surgical Pathway

AbstractBackgroundPatients with chronic obstructive pulmonary disease (COPD) are at increased risk of complications and death following surgery. Pulmonary complications are particularly prominent. Pulmonary rehabilitation is a course of physical exercise and education that helps people with COPD manage their condition. Although proven to improve health outcomes in patients with stable COPD, it has never been formally tested as a pre-surgical intervention in patients scheduled for non-cardiothoracic surgery. If a beneficial effect were to be demonstrated, pulmonary rehabilitation for pre-surgical patients with COPD might be rapidly implemented across the National Health Service, as pulmonary rehabilitation courses are already well established across much of the United Kingdom (UK).MethodsWe performed a feasibility study to test study procedures and barriers to identification and recruitment to a randomised controlled trial testing whether pulmonary rehabilitation, delivered before major abdominal surgery in a population of people with COPD, would reduce the incidence of post-operative pulmonary complications. This study was run in two UK centres (Oxford and Newcastle upon Tyne).ResultsWe determined that a full randomised controlled trial would not be feasible, due to failure to identify and recruit participants. We identified an unmet need to identify more effectively patients with COPD earlier in the surgical pathway. Service evaluations suggested that barriers to identification and recruitment would likely be the same across other UK hospitals.ConclusionsAlthough pulmonary rehabilitation is a potentially beneficial intervention to prevent post-operative pulmonary complications, a randomised controlled trial is unlikely to recruit sufficient participants to answer our study question conclusively at the present time, when spirometry is not automatically conducted in all patients planned for surgery. As pulmonary rehabilitation is a recommended treatment for all people with COPD, alternative study methods combined with earlier identification of candidate patients in the surgical pathway should be considered.Trial registrationISRCTN 29696295, http://www.isrctn.com/ISRCTN29696295, registered 31st August 2017

scholarly journals Effects of injectable progestogen contraception versus the copper intrauterine device on HIV acquisition: sub-study of a pragmatic randomised controlled trial

2017 ◽  
Vol 43 (3) ◽  
pp. 175-180 ◽  
Author(s):  
G Justus Hofmeyr ◽  
Mandisa Singata-Madliki ◽  
Theresa A Lawrie ◽  
Eduardo Bergel ◽  
Marleen Temmerman
Keyword(s):  
Randomised Controlled Trial ◽  
South African ◽  
Pregnancy Termination ◽  
Controlled Trial ◽  
Intrauterine Device ◽  
Randomised Trial ◽  
Contraceptive Device ◽  
Increased Risk ◽  
Hiv Acquisition ◽  
Randomised Controlled

BackgroundEvidence from observational studies suggests an increased risk of HIV acquisition among women using depot medroxyprogesterone acetate (DMPA) contraception.MethodsWithin the context of a South African programme to increase women's access to the intrauterine contraceptive device (IUD), we conducted a pragmatic, open-label, parallel-arm, randomised controlled trial (RCT) of the IUD versus injectable progestogen contraception (IPC) at two South African hospitals. The primary outcome was pregnancy; secondary outcomes included HIV acquisition. Consenting women attending termination of pregnancy services were randomised after pregnancy termination between July 2009 and November 2012. Condoms were promoted for the prevention of sexually transmitted infections. Voluntary HIV testing was offered at baseline and at 12 or more months later. Findings on HIV acquisition are reported in this article.ResultsHIV acquisition data were available for 1290 initially HIV-negative women who underwent a final study interview at a median of 20 months after randomisation to IPC or an IUD. Baseline group characteristics were comparable. In the IPC group, 545/656 (83%) of participants received DMPA, 96 (15%) received injectable norethisterone enanthate, 14 (2%) received the IUD and one received oral contraception. In the IUD group 609 (96%) received the IUD, 20 (3%) received IPC and 5 (1%) had missing data. According to intention-to-treat analysis, HIV acquisition occurred in 20/656 (3.0%) women in the IPC arm and 22/634 (3.5%) women in the IUD arm (IPC vs IUD, risk ratio 0.88; 95% confidence interval 0.48–1.59;p=0.7).ConclusionsThis sub-study was underpowered to rule out moderate differences in HIV risk, but confirms the feasibility of randomised trial methodology to address this question. Larger RCTs are needed to determine the relative risks of various contraceptive methods on HIV acquisition with greater precision.Trial registration numberPan African Clinical Trials Registry number PACTR201409000880157 (04-09-2014).

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