Evidence map›Paper›PMID 38001507›Full record

ArticleTrials2023

Awareness with paralysis and symptoms of post-traumatic stress disorder among mechanically ventilated emergency department survivors (ED-AWARENESS-2 Trial): study protocol for a pragmatic, multicenter, stepped wedge cluster randomized trial.

Brian M Fuller, Brian E Driver, Michael B Roberts, Christa A Schorr, Kathryn Thompson, Brett Faine, Julianne Yeary, Nicholas M Mohr, Ryan D Pappal, Robert J Stephens and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05534243 (Awareness With Paralysis and Post-Traumatic Stress Disorder Among Mechanically Ventilated Emergency Department Survivors), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 23% 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.

NCT05534243 narecruitingnot on this map

Awareness With Paralysis and Post-Traumatic Stress Disorder Among Mechanically Ventilated Emergency Department Survivors: the ED-AWARENESS-2 Trial

TypeinterventionalSponsorWashington University School of MedicineRan2023 to 2027Enrolled3,090ConditionsAwareness, Mechanical Ventilation, Intubation Complication, PTSDArmsStandard neuromuscular blocker practices, Education
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Dexmedetomidine in The Treatment of Toxicologic Conditions in The Emergency Department: A Dual-Center Retrospective Observational Cohort Study.Journal of medical toxicology : official journal of the American College of Medical Toxicology · 2026
    Observational
  2. Post-intubation sedation in the emergency department: A scoping review.The American journal of emergency medicine · 2026
    Article
  3. Intraoperative Awareness during Rhinoplasty.AHRQ WebM&M : morbidity & mortality rounds on the Web · 2024
    Article
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

13 authors at 12 institutions in 1 country.

Brian M FullerDepartment of Anesthesiology, Division of Critical Care, Department of Emergency Medicine, Washington University in St. Louis School of Medicine, St. Louis, MO, 63110, USA. fullerb@wustl.edu.
Brian E DriverDepartment of Emergency Medicine, Hennepin County Medical Center, 701 Park Avenue, Minneapolis, MN, 55415, USA.
Michael B RobertsDepartment of Institutional Research, Department of Psychology, Philadelphia College of Osteopathic Medicine, Rowland Hall, 514B, 4190 City Avenue, Philadelphia, PA, 19131, USA.
Christa A SchorrCooper Research Institute, Cooper University Health Care, One Cooper Plaza, Dorrance, Camden, NJ, 08103, USA.
Kathryn ThompsonDepartment of Emergency Medicine, University of Washington/Harborview Medical Center, 325 9th Avenue, Seattle, WA, 98104, USA.
Brett FaineDepartments of Emergency Medicine and Pharmacy, Roy J. and Lucille A. Carver College of Medicine, University of Iowa College of Pharmacy, 200 Hawkins Drive, 1008 RCP, Iowa City, IA, 52242, USA.
Julianne YearyEmergency Department, Charles F. Knight Emergency and Trauma Center, Barnes-Jewish Hospital, 1 Barnes Jewish Hospital Plaza, St. Louis, MO, 63110, USA.
Nicholas M MohrDepartments of Emergency Medicine and Anesthesiology, Division of Critical Care, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, 200 Hawkins Drive, 1008 RCP, Iowa City, IA, 52242, USA.
Ryan D PappalDepartment of Emergency Medicine, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
Robert J StephensDepartment of Medicine, Division of Critical Care Medicine, University of Maryland School of Medicine, 655 W. Baltimore Street, Baltimore, MD, 21201, USA.
Yan YanDivision of Public Health Sciences, Department of Surgery, Division of Biostatistics, Washington University School of Medicine, 418E, 2Nd Floor, 600 South Taylor Ave., St. Louis, MO, 63110, USA.
Nicholas J JohnsonDepartments of Emergency Medicine and Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington/Harborview Medical Center, 325 9th Avenue, Seattle, WA, 98104, USA.
Brian W RobertsDepartment of Emergency Medicine, Cooper Medical School of Rowan University, One Cooper Plaza, K152, Camden, NJ, 08103, USA.
Washington University in St. Louis · USBarnes-Jewish Hospital · USBeth Israel Deaconess Medical Center · USCooper Medical School of Rowan University · USCooper University Health Care · USHarborview Medical Center · USHennepin County Medical Center · USPhiladelphia College of Osteopathic Medicine · USUniversity of Iowa · USUniversity of Iowa Health Care · USUniversity of Maryland, Baltimore · USUniversity of Washington · US

Funding

Awareness with Paralysis and Post-Traumatic Stress Disorder among Mechanically Ventilated Emergency Department Survivors: The ED-AWARENESS-2 StudyR01HL162721 · NHLBI · WASHINGTON UNIVERSITY · PI Brian M Fuller · 2023 to 2026
$2.7M
NHLBI NIH HHS R01 HL162721NHLBI NIH HHS R01HL162721
6 · The paper itself

Abstract

backgroundAwareness with paralysis (AWP) is memory recall during neuromuscular blockade (NMB) and can cause significant psychological harm. Decades of effort and rigorous trials have been conducted to prevent AWP in the operating room, where prevalence is 0.1-0.2%. By contrast, AWP in mechanically ventilated emergency department (ED) patients is common, with estimated prevalence of 3.3-7.4% among survivors given NMB. Longer-acting NMB use is a critical risk for AWP, and we have shown an association between ED rocuronium use and increased AWP prevalence. As NMB are given to more than 90% of ED patients during tracheal intubation, this trial provides a platform to test an intervention aimed at reducing AWP. The overall objective is to test the hypothesis that limiting ED rocuronium exposure will significantly reduce the proportion of patients experiencing AWP.

methodsThis is a pragmatic, stepped wedge cluster randomized trial conducted in five academic EDs, and will enroll 3090 patients. Per the design, all sites begin in a control phase, under observational conditions. At 6-month intervals, sites sequentially enter a 2-month transition phase, during which we will implement the multifaceted intervention, which will rely on use of nudges and defaults to change clinician decisions regarding ED NMB use. During the intervention phase, succinylcholine will be the default NMB over rocuronium. The primary outcome is AWP, assessed with the modified Brice questionnaire, adjudicated by three independent, blinded experts. The secondary outcome is the proportion of patients developing clinically significant symptoms of post-traumatic stress disorder at 30 and 180 days after hospital discharge. We will also assess for symptoms of depression and anxiety, and health-related quality of life. A generalized linear model, adjusted for time and cluster interactions, will be used to compare AWP in control versus intervention phases, analyzed by intention-to-treat. DISCUSSION: The ED-AWARENESS-2 Trial will be the first ED-based trial aimed at preventing AWP, a critical threat to patient safety. Results could shape clinical use of NMB in the ED and prevent more than 10,000 annual cases of AWP related to ED care.

trial registrationClinicalTrials.gov identifier NCT05534243 . Registered 06, September 2022.

Indexed as

Stress Disorders, Post-TraumaticEmergency Service, HospitalHumansMulticenter Studies as TopicParalysisPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicRespiration, ArtificialRocuroniumRocuroniumAwareness with paralysisCritical careEmergency medicineMechanical ventilationPost-traumatic stress disorderSedation

Identifiers

PMID38001507
PMCPMC10675941
OpenAlexW4389001787

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.