The ED-AWARENESS-2 Trial

Not Applicable

Recruiting

• Conditions: Intubation Complication; Mechanical Ventilation; PTSD; Awareness
• Interventions: Behavioral: Education; Other: Standard neuromuscular blocker practices

• Registration Number: NCT05534243
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-09
• Study Start: 2023-06-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-04-01
• Primary Completion: 2027-03-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3090

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
After group	Education	Mechanically ventilated emergency department patients receiving neuromuscular blockers after an educational initiative aimed at improving use of shorter acting neuromuscular blocker practices in the ED.
Before group	Standard neuromuscular blocker practices	Mechanically ventilated emergency department patients receiving standard neuromuscular blockers prior to an educational initiative on the importance of ED-based targeted shorter acting neuromuscular blocker.

Primary Outcome Measures

Name	Time	Method
The prevention of Awareness with Paralysis, as assessed by the modified Brice questionnaire.	up to 30 days	The modified Brice questionnaire will be used in this trial.

Secondary Outcome Measures

Name	Time	Method
PTSD symptoms	180 days	Will be measured using the PCL-5, a validated 20-item (score 0-4, Likert scale) self-reported measure that assesses 20 DSM-5 symptoms of PTSD.
Depression and Anxiety	180 days	Hospital Anxiety and Depression Scale (HADS), a validated 14-item (7 depression, 7 anxiety, ordinal score 0-3) questionnaire commonly used in critical illness
Health Related Quality of Life (QOL)	180 days	EuroQol-5D (EQ-5D), the most widely used scale for measuring health-related QOL and part of the core sets recommended for critical care studies on post-discharge outcomes

Trial Locations

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