scholarly journals Comparison of high flow nasal cannula oxygen and conventional oxygen therapy on ventilatory support duration during acute-on-chronic respiratory failure: study protocol of a multicentre, randomised, controlled trial. The ‘HIGH-FLOW ACRF’ study

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e022983 ◽  
Author(s):  
Jean-Damien Ricard ◽  
Fadia Dib ◽  
Marina Esposito-Farese ◽  
Jonathan Messika ◽  
Christophe Girault
Keyword(s):  
Respiratory Failure ◽  
Study Protocol ◽  
Controlled Trial ◽  
Ventilatory Support ◽  
Good Clinical Practice ◽  
Trial Steering Committee ◽  
High Flow ◽  
Hospital Length Of Stay ◽  
Open Label ◽  
Randomised Controlled

IntroductionThis study protocol describes a trial designed to investigate whether high-flow heated and humidified nasal oxygen (HFHO) therapy in patients with hypercapnic acute respiratory failure (ARF) reduces the need of non-invasive ventilation (NIV).Methods and analysisThis is an open-label, superiority, international, parallel-group, multicentre randomised controlled two-arm trial, with an internal feasibility pilot phase. 242 patients with hypercapnic ARF requiring NIV admitted to an intensive care unit, an intermediate care or a respiratory care unit will be randomised in a 1:1 ratio to receive HFHO or standard oxygen in between NIV sessions. Randomisation will be centralised and stratified by centre and pH at admission (pH ≤7.25 or >7.25). The primary outcome will be the number of ventilator-free days (VFDs) and alive at day 28 postrandomisation. The secondary outcomes will encompass parameters related to the VFDs, comfort and tolerance variables, hospital length of stay and mortality. VFDs at 28 days postrandomisation will be compared between the two groups by Wilcoxon-Mann-Whitney two-sample rank-sum test in the intention-to-treat population. A sensitivity analysis will be conducted in the population of patients for whom the criteria of switching from NIV to spontaneous breathing, or conversely, are not strictly verified.Ethics and disseminationThe protocol has been approved by theComité de Protection des Personnes(CPP)Sud-Ouest & Outre-Mer IV(ref CPP17-049a/2017-A01830-53) and will be carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. A trial steering committee will oversee the progress of the study. Findings will be disseminated through national and international scientific conferences, and publication in peer-reviewed journals.Trial registration numberNCT03406572.

scholarly journals SUGAR-DIP trial: oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e029808 ◽  
Author(s):  
Leon de Wit ◽  
Doortje Rademaker ◽  
Daphne N Voormolen ◽  
Bettina M C Akerboom ◽  
Rosalie M Kiewiet-Kemper ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Glycaemic Control ◽  
Study Protocol ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Large For Gestational Age ◽  
Secondary Outcome ◽  
Oral Glucose ◽  
Open Label ◽  
Randomised Controlled

IntroductionIn women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM.MethodsThe SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle.Ethics and disseminationThe study protocol was approved by the Ethics Committee of the Utrecht University Medical Centre. Approval by the boards of management for all participating hospitals will be obtained. Trial results will be submitted for publication in peer-reviewed journals.Trial registration numberNTR6134; Pre-results.

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