The ED-AWARENESS-2 Trial
ED-AWARENES II
Awareness With Paralysis and Post-Traumatic Stress Disorder Among Mechanically Ventilated Emergency Department Survivors: the ED-AWARENESS-2 Trial
2 other identifiers
interventional
3,090
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2022
CompletedFirst Posted
Study publicly available on registry
September 9, 2022
CompletedStudy Start
First participant enrolled
June 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
March 12, 2026
March 1, 2026
3.7 years
September 2, 2022
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The prevention of Awareness with Paralysis, as assessed by the modified Brice questionnaire.
The modified Brice questionnaire will be used in this trial.
up to 30 days
Secondary Outcomes (6)
PTSD symptoms
30 days
PTSD symptoms
180 days
Depression and Anxiety
30 days
Depression and Anxiety
180 days
Health Related Quality of Life (QOL)
30 days
- +1 more secondary outcomes
Study Arms (2)
Before group
ACTIVE COMPARATORMechanically ventilated emergency department patients receiving standard neuromuscular blockers prior to an educational initiative on the importance of ED-based targeted shorter acting neuromuscular blocker.
After group
EXPERIMENTALMechanically ventilated emergency department patients receiving neuromuscular blockers after an educational initiative aimed at improving use of shorter acting neuromuscular blocker practices in the ED.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Mechanical ventilation via an endotracheal tube
- Age ≥ 18 years
- Treatment with a neuromuscular blocker (for endotracheal intubation or during the post-intubation phase of care)
You may not qualify if:
- Acute or chronic neurologic injury with deficit that prevents assessment of AWP (i.e. stroke, intracranial hemorrhage, traumatic brain injury, cardiac arrest, severe dementia)
- Death before extubation
- Transfer to another hospital from the ED
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Roy J. and Lucille A. Carver College of Medicine
Iowa City, Iowa, 52242, United States
Hennepin Healthcare
Minneapolis, Minnesota, 55415, United States
Cooper University Hospital/Cooper Medical School of Rowan University
Camden, New Jersey, 08103, United States
University of Washington School of Medicine
Seattle, Washington, 98195, United States
Related Publications (1)
Fuller BM, Driver BE, Roberts MB, Schorr CA, Thompson K, Faine B, Yeary J, Mohr NM, Pappal RD, Stephens RJ, Yan Y, Johnson NJ, Roberts BW. Awareness with paralysis and symptoms of post-traumatic stress disorder among mechanically ventilated emergency department survivors (ED-AWARENESS-2 Trial): study protocol for a pragmatic, multicenter, stepped wedge cluster randomized trial. Trials. 2023 Nov 25;24(1):753. doi: 10.1186/s13063-023-07764-5.
PMID: 38001507DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Fuller, MD
Washington University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Anesthesiology (Critical Care Medicine) and Emergency Medicine
Study Record Dates
First Submitted
September 2, 2022
First Posted
September 9, 2022
Study Start
June 28, 2023
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Starting 6 months after all publications related to the data.
- Access Criteria
- Can be obtained by contacting the study PI.
We will consider sharing IPD upon reasonable request