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NCT05534243 · ClinicalTrials.gov registry record · NA
The ED-AWARENESS-2 Trial
A NA study of PTSD and Mechanical Ventilation, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- NA
- Development phase
- 3,090
- Enrollment target
- 4
- Study locations
NCT05534243 is a NA study of PTSD and Mechanical Ventilation that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 3,090 participants, above the 282-participant average among 154 other PTSD trials with a reported enrollment target (996% higher). The trial reports 4 study locations across 4 states.
The verdict
NCT05534243, a NA study of PTSD and Mechanical Ventilation, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- NA
- Development phase
- 3,090 participants
- Enrollment target
- 4
- Study locations
Study 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 def
Conditions Studied
Interventions
- BEHAVIORAL Education
- OTHER Standard neuromuscular blocker practices
Study Locations (4)
Iowa
- Roy J. and Lucille A. Carver College of Medicine - Iowa City
Minnesota
- Hennepin Healthcare - Minneapolis
New Jersey
- Cooper University Hospital/Cooper Medical School of Rowan University - Camden
Washington
- University of Washington School of Medicine - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,090 participants |
| Start Date | 2023-06-28 |
| Est. Completion | 2027-09-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05534243
The ClinicalTrials.gov registry entry for NCT05534243 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 3,090 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 282-participant average among 154 other PTSD trials with a reported enrollment target (996% higher). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which Education is the first listed.
NCT05534243 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Iowa, Minnesota, New Jersey.
Frequently Asked Questions
What is clinical trial NCT05534243 about?
NCT05534243 is a clinical study titled "The ED-AWARENESS-2 Trial". 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-ye...
What is the current status of trial NCT05534243?
This trial is currently recruiting. It is a NA study. The enrollment target is 3,090 participants. The study started on 2023-06-28. Estimated completion is 2027-09-01.
What conditions does trial NCT05534243 study?
This clinical trial studies the following conditions: PTSD, Mechanical Ventilation, Intubation Complication, Awareness.
What interventions are being tested in trial NCT05534243?
The interventions under investigation include: Education (BEHAVIORAL), Standard neuromuscular blocker practices (OTHER).
Who is sponsoring clinical trial NCT05534243?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05534243 being conducted?
This trial has 4 study locations across Iowa, Minnesota, New Jersey, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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