Investigating neuromuscular blockers in mechanically ventilated patients
Official title: Awareness With Paralysis and Post-Traumatic Stress Disorder Among Mechanically Ventilated Emergency Department Survivors: the ED-AWARENESS-2 Trial
Run by Washington University School of Medicine · NCT05534243 · Data updated 2026-11-12
This study is testing how different muscle relaxants affect patients on ventilators in emergency departments to see if they improve outcomes and reduce complications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3212 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 4 sites (Iowa City, Iowa and 3 other locations) |
| Status | Recruiting |
| Started | June 28, 2023 |
| Main results expected | June 30, 2026 |
| Study ends | September 1, 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT05534243 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who are undergoing mechanical ventilation and require treatment with a neuromuscular blocker.
✕Probably not a fit
Patients with acute or chronic neurologic injuries that impair assessment or those who die before extubation will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to evaluate the effects of different neuromuscular blockers on patients who are mechanically ventilated in emergency departments. It will involve screening and enrolling eligible patients across five medical centers over three years, using a stepped wedge cluster randomized design. Initially, all sites will provide usual care, followed by a transition to using succinylcholine as the default neuromuscular blocker in a staggered manner. The study will assess the impact of these interventions on patient outcomes, particularly focusing on awareness and complications related to intubation.
Why it matters
Potential benefit: If successful, this study could improve the management of mechanically ventilated patients and reduce complications associated with intubation.
How similar studies have gone: Previous studies have shown varying success with similar approaches, but this specific design and focus on neuromuscular blockers in emergency settings is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Mechanical ventilation via an endotracheal tube 2. Age ≥ 18 years 3. Treatment with a neuromuscular blocker (for endotracheal intubation or during the post-intubation phase of care) Exclusion Criteria: 1. Acute or chronic neurologic injury with deficit that prevents assessment of AWP (i.e. stroke, intracranial hemorrhage, traumatic brain injury, cardiac arrest, severe dementia) 2. Death before extubation 3. Transfer to another hospital from the ED
Where it's running
-
Roy J. and Lucille A. Carver College of Medicine
Iowa City, Iowa, United States Recruiting -
Hennepin Healthcare
Minneapolis, Minnesota, United States Recruiting -
Cooper University Hospital/Cooper Medical School of Rowan University
Camden, New Jersey, United States Recruiting -
University of Washington School of Medicine
Seattle, Washington, United States Recruiting
Study contacts
- Principal investigator: Brian Fuller, MD — Washington University School of Medicine
- Study coordinator: Brian Fuller, MD
- Email: fullerb@wustl.edu
- Phone: 314-747*5368
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.