RecruitingNot ApplicableNCT05534243

The ED-AWARENESS-2 Trial

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


Sponsor

Washington University School of Medicine

Enrollment

3,090 participants

Start Date

Jun 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial studies how often patients on a breathing machine become aware during surgery or ICU care while receiving a paralytic medication, and how to better detect and prevent it. **You may be eligible if...** - You are 18 years or older - You are on a breathing machine (mechanical ventilation) with a tube in your airway - You are receiving a neuromuscular blocking drug (a paralytic medication) **You may NOT be eligible if...** - You have an acute or chronic brain or nerve injury that prevents assessment - You pass away before the breathing tube is removed - You are transferred to another hospital during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStandard neuromuscular blocker practices

Usual care neuromuscular blocker in the ED

BEHAVIORALEducation

Nurses and physicians will be engaged regarding the clinical outcome data on the importance of shorter acting neuromuscular blockers, and the objectives of the research. Education will include in-services and lectures focused on the importance of neuromuscular blocker protocols on patient outcome. The use of neuromuscular blokers will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based neuromuscular blocker protocols.


Locations(4)

Roy J. and Lucille A. Carver College of Medicine

Iowa City, Iowa, United States

Hennepin Healthcare

Minneapolis, Minnesota, United States

Cooper University Hospital/Cooper Medical School of Rowan University

Camden, New Jersey, United States

University of Washington School of Medicine

Seattle, Washington, United States

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NCT05534243


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