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Design and Rationale of the Reevaluation of Systemic Early Neuromuscular Blockade Trial for Acute Respiratory Distress Syndrome.
- Source :
- Annals of the American Thoracic Society; Jan2017, Vol. 14 Issue 1, p124-133, 10p
- Publication Year :
- 2017
-
Abstract
- The Reevaluation of Systemic Early Neuromuscular Blockade (ROSE) trial is a multicenter, randomized trial designed to assess the efficacy and safety of early neuromuscular blockade in patients with moderate to severe acute respiratory distress syndrome. This document provides background for interpretation of the trial results, and highlights unique design approaches that may inform future trials of acute illness. We describe the process by which ROSE was chosen as the inaugural trial of the multidisciplinary Prevention and Early Treatment of Acute Lung Injury Network, provide the trial methodology using the Consolidated Standards of Reporting Trials framework, and discuss key design challenges and their resolution. Four key design issues proved challenging-feasibility, choice of sedation depth in the control group, impact of emphasizing early treatment on enrollment criteria and protocol execution, and choice of positive end-expiratory pressure strategy. We used literature, an iterative consensus model, and internal surveys of current practice to inform design choice. ROSE will provide definitive, Consolidated Standards of Reporting Trials adherent data on early neuromuscular blockade for future patients with acute respiratory distress syndrome. Our multidisciplinary approach to trial design may be of use to other trials of acute illness. Clinical trial registered with www.clinicaltrials.gov (NCT02509078). [ABSTRACT FROM AUTHOR]
- Subjects :
- ADULT respiratory distress syndrome treatment
ARTIFICIAL respiration
ATRACURIUM
COMPARATIVE studies
CAUSES of death
RESEARCH methodology
MEDICAL cooperation
MEMORY
MORTALITY
MUSCLE strength
NEUROMUSCULAR blocking agents
RESEARCH
RESEARCH funding
PILOT projects
EVALUATION research
RANDOMIZED controlled trials
POSITIVE end-expiratory pressure
THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 23296933
- Volume :
- 14
- Issue :
- 1
- Database :
- Complementary Index
- Journal :
- Annals of the American Thoracic Society
- Publication Type :
- Academic Journal
- Accession number :
- 122226366
- Full Text :
- https://doi.org/10.1513/AnnalsATS.201608-629OT