Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05534243

The ED-AWARENESS-2 Trial

Led by Washington University School of Medicine · Updated on 2026-03-12

3090

Participants Needed

4

Research Sites

218 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 initiation of mechanical ventilation for patients with acute respiratory failure. The two most common neuromuscular blockers used in the ED are succinylcholine and rocuronium. The preliminary data show a strong association between rocuronium (a longer-acting neuromuscular blocker) use and AWP. Therefore, this study aims to improve care by educating caregivers on AWP and the use of the neuromuscular blockers, which are already routinely used, and studying that process in a rigorous fashion. The default neuromuscular blocker in the intervention phase will be succinylcholine. Succinylcholine will be the default over rocuronium because: 1) it has safely been the default neuromuscular blocker of choice in the ED for \>40 years ; 2) its 5-minute duration of action greatly reduces AWP risk; 3) the preliminary data regarding an increased risk of AWP with rocuronium and 4) ED rocuronium use has increased despite no patient-centered studies showing benefit over succinylcholine. Passive alerts (i.e. graphics, pocket cards) will also be strategically placed in the ED, and active alerts will be used as reminders before every nursing shift (i.e. "the huddle"). After this transition phase, the site will begin the intervention phase, and patients will again receive clinician-directed care, just after the intervention.

CONDITIONS

Official Title

The ED-AWARENESS-2 Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Mechanical ventilation via an endotracheal tube
  • Age 18 years or older
  • Treatment with a neuromuscular blocker for intubation or post-intubation care
Not Eligible

You will not qualify if you...

  • Acute or chronic neurologic injury preventing assessment of awareness with paralysis (e.g., stroke, intracranial hemorrhage, traumatic brain injury, cardiac arrest, severe dementia)
  • Death before extubation
  • Transfer to another hospital from the emergency department

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Roy J. and Lucille A. Carver College of Medicine

Iowa City, Iowa, United States, 52242

Actively Recruiting

2

Hennepin Healthcare

Minneapolis, Minnesota, United States, 55415

Actively Recruiting

3

Cooper University Hospital/Cooper Medical School of Rowan University

Camden, New Jersey, United States, 08103

Actively Recruiting

4

University of Washington School of Medicine

Seattle, Washington, United States, 98195

Actively Recruiting

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Research Team

B

Brian Fuller, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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The ED-AWARENESS-2 Trial | DecenTrialz