The ED-AWARENESS-2 Trial

Study acronym: ED-AWARENES II
StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Minor Primary completion date changed from estimate of Mar 1, 2027 to Jun 30, 2026 Show 4 more changesShow less
    • Enrollment target: 3090 to 3212
    • Eligibility criteria expanded, about 6 words
    • Site details revised at 1 of 4 sites
    • Publications: details revised at 1 of 1 entry
  2. Minor 2 versions Re-verified since Mar 25, 2025, no change to tracked fieldsv7-v8
  3. Notable Primary endpoint revisedv6
  4. Notable Primary endpoint revisedv5
  5. Notable Primary completion date: Jul 1, 2026 to Mar 1, 2027
    • Study completion date: Jul 1, 2026 to Sep 1, 2027
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 1, 2023 to Jun 28, 2023
    • Site details revised at 4 of 4 sites
    v3
  2. Minor Collaborators expanded, about 7 wordsv2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05534243
Lead Sponsor Washington University School of Medicine
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)
Awareness, Mechanical Ventilation, Intubation Complication, PTSD
Related terms Paralysis, Stress Disorders, Post-Traumatic
Enrollment 3,212 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov