Investigating neuromuscular blockers in mechanically ventilated patients
Awareness With Paralysis and Post-Traumatic Stress Disorder Among Mechanically Ventilated Emergency Department Survivors: the ED-AWARENESS-2 Trial
NA · Washington University School of Medicine · NCT05534243
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 3090 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine (other) |
| Locations | 4 sites (Iowa City, Iowa and 3 other locations) |
| Trial ID | NCT05534243 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing mechanical ventilation and require treatment with a neuromuscular blocker.
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.
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 performed: Previous studies have shown varying success with similar approaches, but this specific design and focus on neuromuscular blockers in emergency settings is relatively novel.
Eligibility criteria
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 this trial is running
Iowa City, Iowa and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Awareness, Mechanical Ventilation, Intubation Complication, PTSD, Paralysis, Emergancy Department, Rocuronium, Intubation