An interventional study of Standard neuromuscular blocker practices and Education in Awareness, Mechanical Ventilation and Intubation Complication, sponsored by Washington University School of Medicine. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Supportive care
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.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 3,212 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Standard neuromuscular blocker practices
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.
Behavioral: Education
Usual care neuromuscular blocker in the ED
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.
The prevention of Awareness with Paralysis, as assessed by the modified Brice questionnaire.
The modified Brice questionnaire will be used in this trial.
Time frame: up to 30 days
PTSD symptoms
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.
Time frame: 30 days
PTSD symptoms
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.
Time frame: 180 days
Depression and Anxiety
Hospital Anxiety and Depression Scale (HADS), a validated 14-item (7 depression, 7 anxiety, ordinal score 0-3) questionnaire commonly used in critical illness
Time frame: 30 days
Depression and Anxiety
Hospital Anxiety and Depression Scale (HADS), a validated 14-item (7 depression, 7 anxiety, ordinal score 0-3) questionnaire commonly used in critical illness
Time frame: 180 days
Health Related Quality of Life (QOL)
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
Time frame: 30 days
Health Related Quality of Life (QOL)
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
Time frame: 180 days
Plan to share: Yes — We will consider sharing IPD upon reasonable request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Starting 6 months after all publications related to the data.
Access criteria: Can be obtained by contacting the study PI.
Ran from Jun 2023 to primary completion in Jun 2026, 36 months.
Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 36 months is close to that.
Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
Primary completion moved once since we started tracking on Sep 25, 2026: Mar 2027 → Jun 2026, on Oct 13, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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