After group for Ventilations, Mechanical

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Washington School of Medicine, Seattle, WA
Ventilations, Mechanical+4 More
Education - Behavioral
Eligibility
18+
All Sexes
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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 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.

Eligible Conditions

  • Ventilations, Mechanical
  • Post Traumatic Stress Disorder (PTSD)
  • Intubation; Complication
  • Awareness

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 180 days

180 days
Depression and Anxiety
Health Related Quality of Life (QOL)
PTSD symptoms
up to 30 days
Proportion of patients experiencing Awareness with Paralysis (AWP) in the control phase versus the intervention phase

Trial Safety

Trial Design

2 Treatment Groups

Before group
1 of 2
After group
1 of 2
Active Control
Experimental Treatment

3090 Total Participants · 2 Treatment Groups

Primary Treatment: After group · No Placebo Group · N/A

After group
Behavioral
Experimental Group · 1 Intervention: Education · Intervention Types: Behavioral
Before group
Other
ActiveComparator Group · 1 Intervention: Standard neuromuscular blocker practices · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Education
2017
Completed Phase 3
~4010

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 180 days

Trial Background

Prof. Brian Fuller, Associate Professor of Anesthesiology (Critical Care Medicine) and Emergency Medicine
Principal Investigator
Washington University School of Medicine
Closest Location: University of Washington School of Medicine · Seattle, WA
Photo of Seattle  1Photo of Seattle  2Photo of Seattle  3
2004First Recorded Clinical Trial
1 TrialsResearching Ventilations, Mechanical
37 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.