Design and rationale of the reevaluation of systemic early neuromuscular blockade trial for acute respiratory distress syndrome

Reevaluation of Systemic Early Neuromuscular Blockade Protocol Committee and the National Institutes of Health National Heart Lung and Blood Institute Prevention and Early Treatment of Acute Lung Injury Network Investigators

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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.

Original languageEnglish (US)
Pages (from-to)124-133
Number of pages10
JournalAnnals of the American Thoracic Society
Volume14
Issue number1
DOIs
StatePublished - Jan 2017

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Keywords

  • Adult
  • Clinical trial
  • Interdisciplinary communication
  • Methods
  • Respiratory distress syndrome

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Reevaluation of Systemic Early Neuromuscular Blockade Protocol Committee and the National Institutes of Health National Heart Lung and Blood Institute Prevention and Early Treatment of Acute Lung Injury Network Investigators (2017). Design and rationale of the reevaluation of systemic early neuromuscular blockade trial for acute respiratory distress syndrome. Annals of the American Thoracic Society, 14(1), 124-133. https://doi.org/10.1513/AnnalsATS.201608-629OT