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Study identifier: NCT05534243 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

The ED-AWARENESS-2 Trial

Condition: Awareness · Mechanical Ventilation · Intubation Complication  ·  Sponsor: Washington University School of Medicine

PhaseNA
Planned participants3090
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The investigators will screen all mechanically ventilated ED patients for study eligibility and will enroll all consecutive patients satisfying inclusion and exclusion criteria. The study design is a pragmatic, multicenter, stepped wedge cluster randomized trial, enrolling at five sites over a 3-year period, divided into six time periods of six months. Prior to the study, each site will be randomized to their position within the design. One site will cross to the intervention period (i.e. succinylcholine as default neuromuscular blocker) every six months from the 2nd to 6th time period. Cluster order will be determined by computer-based randomization. To begin, each site will be exposed to control conditions; by the end of the study, each site will be exposed to intervention conditions. Patients in the control phase will receive usual care, and this phase will be entirely observational. After six months, a site will enter a 2-month transition phase. In this phase, the investigators will implement the intervention, similar to how they have implemented other ED-based interventions for mechanically ventilated patients. The investigators will engage and educate ED clinicians on the importance of AWP prevention and the study objectives. The intervention framework relies on the use of "nudges", without restricting choice. The use of neuromuscular blockers (i.e. "paralytic" medications) is already part of routine care in the ED in order to facilitate endotracheal intubation and in…

This description comes directly from the study's public registry record.

Talk to the study team

Brian Fuller, MD  ·  314-747*5368  ·  fullerb@wustl.edu

Always discuss trial participation with your own doctor first.

Locations (4)

Roy J. and Lucille A. Carver College of MedicineIowa City, Iowa, United StatesRecruiting
Hennepin HealthcareMinneapolis, Minnesota, United StatesRecruiting
Cooper University Hospital/Cooper Medical School of Rowan UniversityCamden, New Jersey, United StatesRecruiting
University of Washington School of MedicineSeattle, Washington, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05534243