Evidence map›Paper›PMID 27779896›Full record

Trial reportAnnals of the American Thoracic Society2017

Design and Rationale of the Reevaluation of Systemic Early Neuromuscular Blockade Trial for Acute Respiratory Distress Syndrome.

David T Huang, Derek C Angus, Marc Moss, B Taylor Thompson, Niall D Ferguson, Adit Ginde, Michelle Ng Gong, Stephanie Gundel, Douglas L Hayden, R Duncan Hite and 7 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of the American Thoracic Society, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02509078 (Reevaluation Of Systemic Early Neuromuscular Blockade), which is not on this map. Cited by 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 2 pooled it
6.7field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02509078 phase3completednot on this map

Reevaluation Of Systemic Early Neuromuscular Blockade

TypeinterventionalSponsorMassachusetts General HospitalRan2016 to 2019Enrolled1,008ConditionsAcute Respiratory Distress SyndromeArmsCisatracurium Besylate
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 61 citations in OpenAlex.

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  19. Revisiting Old Friends: Adjunctive Therapies in Acute Respiratory Distress Syndrome.American journal of respiratory and critical care medicine · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 9 institutions in 2 countries.

David T Huang1 University of Pittsburgh, Pittsburgh, Pennsylvania.ORCID http://orcid.org/0000-0001-7649-1633
Derek C Angus1 University of Pittsburgh, Pittsburgh, Pennsylvania.
Marc Moss2 University of Colorado, Denver, Colorado.
B Taylor Thompson3 Harvard Medical School, Boston, Massachusetts.
Niall D Ferguson4 University of Toronto, Toronto, Ontario, Canada.
Adit Ginde2 University of Colorado, Denver, Colorado.
Michelle Ng Gong5 Albert Einstein College of Medicine, New York, New York.
Stephanie Gundel6 University of Washington, Seattle, Washington.
Douglas L Hayden3 Harvard Medical School, Boston, Massachusetts.
R Duncan Hite7 Cleveland Clinic, Cleveland, Ohio.
Peter C Hou3 Harvard Medical School, Boston, Massachusetts.
Catherine L Hough6 University of Washington, Seattle, Washington.
Theodore J Iwashyna8 University of Michigan, Ann Arbor, Michigan; and.
Kathleen D Liu9 University of California, San Francisco, San Francisco, California.
Daniel S Talmor3 Harvard Medical School, Boston, Massachusetts.
Donald M Yealy1 University of Pittsburgh, Pittsburgh, Pennsylvania.
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
Harvard University · USUniversity of Pittsburgh · USUniversity of Colorado Denver · USUniversity of Washington · USAlbert Einstein College of Medicine · USCleveland Clinic · USUniversity of California, San Francisco · USUniversity of Michigan · USUniversity of Toronto · CA

Funding

CCC for NHLBI Prevention and Early Treatment of Acute Lung Injury PETAL NetworkU01HL123009 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI FOULKES, ANDREA S, THOMPSON, BOYD TAYLOR · 2014 to 2021
$67.2M
Clinical Centers (CC) for the NHLBI Prevention and Early Treatment of Acute LungU01HL123022 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI SHAPIRO, NATHAN I, TALMOR, DANIEL STUART · 2014 to 2020
$2.9M
Prevention and Early Treatment of Acute Lung InjuryU01HL123004 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MATTHAY, MICHAEL A. · 2014 to 2020
$2.6M
Clinical Centers (CC) for the NHLBI Prevention and Early Treatment of Acute LungU01HL123031 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI HYZY, ROBERT C, PARK, PAULINE K · 2014 to 2020
$2.6M
Enhancing the Surrogate Informed Consent Process for Critical Care ResearchU01HL123010 · NHLBI · UNIVERSITY OF COLORADO DENVER · PI GINDE, ADIT A., MOSS, MARC · 2014 to 2020
$2.6M
Prevention and Early Treatment of Acute Lung Injury Clinical Trials NetworkU01HL123033 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI RICE, TODD W · 2014 to 2020
$2.4M
Preventive and Early Treatment of Acute Lung Injury Clinical Trials Network- Pgh - SupplementU01HL123020 · NHLBI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI ANGUS, DEREK C, YEALY, DONALD M · 2014 to 2020
$2.4M
Long Term Outcomes and Macrophage Biology in Patients with EVALIU01HL123018 · NHLBI · IHC HEALTH SERVICES, INC. · PI BLEDSOE, JOSEPH R, BROWN, SAMUEL MORRIS · 2014 to 2020
$2.4M
Pacific Northwest Clinical Center for the NHLBI PETAL NetworkU01HL123008 · NHLBI · UNIVERSITY OF WASHINGTON · PI HOUGH, CATHERINE LEE, ROBINSON, BRYCE · 2014 to 2020
$2.3M
Acute Lung Injury Group New England Program to Support PETAL Network ResearchU01HL122989 · NHLBI · BAYSTATE MEDICAL CENTER, INC. · PI STEINGRUB, JAY S · 2014 to 2020
$2.2M
Einstein PETAL: Clinical Center for the PETAL NetworkU01HL122998 · NHLBI · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI GONG, MICHELLE NG, RICHARDSON, LYNNE D. · 2014 to 2020
$1.9M
Wake Forest Clinical Center for the NHLBI PETAL NetworkU01HL123027 · NHLBI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI FILES, DANIEL CLARK, MILLER, CHADWICK DAVID · 2014 to 2020
$1.8M
NHLBI NIH HHS U01 HL122989NHLBI NIH HHS U01 HL122998NHLBI NIH HHS U01 HL123004NHLBI NIH HHS U01 HL123008NHLBI NIH HHS U01 HL123009NHLBI NIH HHS U01 HL123010NHLBI NIH HHS U01 HL123018NHLBI NIH HHS U01 HL123020NHLBI NIH HHS U01 HL123022NHLBI NIH HHS U01 HL123023NHLBI NIH HHS U01 HL123027NHLBI NIH HHS U01 HL123031NHLBI NIH HHS U01 HL123033
6 · The paper itself

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).

Indexed as

AtracuriumCause of DeathFeasibility StudiesHumansMental RecallMortalityMuscle StrengthNeuromuscular BlockadeNeuromuscular Blocking AgentsPositive-Pressure RespirationRespiration, ArtificialRespiratory Distress SyndromeAtracuriumcisatracuriumNeuromuscular Blocking Agentsadultclinical trialinterdisciplinary communicationmethodsrespiratory distress syndrome

Identifiers

PMID27779896
PMCPMC5291480
OpenAlexW2534521479

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.