| NCT ID | NCT05534243 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Awareness |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,090 participants |
| Start Date | 2023-06-28 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,090 participants in total. It began in 2023-06-28 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Brian Fuller, MD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT05534243 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Awareness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05534243 currently recruiting?
Yes, NCT05534243 is actively recruiting participants. Contact the research team at fullerb@wustl.edu for enrollment information.
Where is the NCT05534243 trial being conducted?
This trial is being conducted at Iowa City, United States, Minneapolis, United States, Camden, United States, Seattle, United States.
Who is sponsoring the NCT05534243 clinical trial?
NCT05534243 is sponsored by Washington University School of Medicine. The principal investigator is Brian Fuller, MD at Washington University School of Medicine. The trial plans to enroll 3,090 participants.