BMJ open
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Randomized Controlled Trial Multicenter Study Comparative Study
McGRATH MAC videolaryngoscope versus Macintosh laryngoscope for orotracheal intubation in intensive care patients: the randomised multicentre MACMAN trial study protocol.
Critically ill patients with acute respiratory, neurological or cardiovascular failure requiring invasive mechanical ventilation are at high risk of difficult intubation and have organ dysfunctions associated with complications of intubation and anaesthesia such as hypotension and hypoxaemia. The complication rate increases with the number of intubation attempts. Videolaryngoscopy improves elective endotracheal intubation. McGRATH MAC is the lightest videolaryngoscope and the most similar to the Macintosh laryngoscope. The primary goal of this trial was to determine whether videolaryngoscopy increased the frequency of successful first-pass intubation in critically ill patients, compared to direct view Macintosh laryngoscopy. ⋯ The study project has been approved by the appropriate ethics committee (CPP Ouest 2, # 2014-A00674-43). Informed consent is not required, as both laryngoscopy methods are considered standard care in France; information is provided before study inclusion. If videolaryngoscopy proves superior to Macintosh laryngoscopy, its use will become standard practice, thereby decreasing first-pass intubation failure rates and, potentially, the frequency of intubation-related complications. Thus, patient safety should benefit. Further studies would be warranted to determine whether videolaryngoscopy is also beneficial in the emergency room and for prehospital emergency care.
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Randomized Controlled Trial Multicenter Study
Clinical effectiveness and cost-effectiveness of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) facilitated self-care rehabilitation intervention in heart failure patients and caregivers: rationale and protocol for a multicentre randomised controlled trial.
The Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) trial is part of a research programme designed to develop and evaluate a health professional facilitated, home-based, self-help rehabilitation intervention to improve self-care and health-related quality of life in people with heart failure and their caregivers. The trial will assess the clinical effectiveness and cost-effectiveness of the REACH-HF intervention in patients with systolic heart failure and impact on the outcomes of their caregivers. ⋯ The study is approved by the North West-Lancaster Research Ethics Committee (ref 14/NW/1351). Findings will be disseminated via journals and presentations to publicise the research to clinicians, commissioners and service users.
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Multicenter Study
Validation and optimisation of an ICD-10-coded case definition for sepsis using administrative health data.
Administrative health data are important for health services and outcomes research. We optimised and validated in intensive care unit (ICU) patients an International Classification of Disease (ICD)-coded case definition for sepsis, and compared this with an existing definition. We also assessed the definition's performance in non-ICU (ward) patients. ⋯ This study demonstrates that sepsis is highly undercoded in administrative data, thus under-ascertaining the true incidence of sepsis. The optimised ICD-coded definition has a higher validity with higher Sn and should be preferentially considered if used for surveillance purposes.
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Randomized Controlled Trial Multicenter Study
Study protocol for a phase III multicentre, randomised, open-label, blinded-end point trial to evaluate the efficacy and safety of immunoglobulin plus cyclosporin A in patients with severe Kawasaki disease (KAICA Trial).
Kawasaki disease (KD) is an acute, self-limited vasculitis of unknown aetiology that predominantly affects infants and young children. We hypothesise that cyclosporin A (CsA) may be effective in treating KD by regulating the Ca(2+)/NFAT signalling pathway. This trial compares the current standard therapy of intravenous immunoglobulin (IVIG) and the combined IVIG+CsA therapy in paediatric patients with severe KD. ⋯ The protocol was approved by the Institutional Review Board of each institution. The trial was notified and registered at the Pharmaceutical and Medical Devices Agency, in Japan. The trial is currently on-going and is scheduled to finish in April 2017. The findings will be disseminated through peer-reviewed publications and conference presentations.