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Caregiver Education for Paralysis Management (ED-AWARENES II Trial)

N/A
Recruiting
Led By Brian Fuller, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Mechanical ventilation via an endotracheal tube
Must not have
Acute or chronic neurologic injury with deficit that prevents assessment of AWP (i.e. stroke, intracranial hemorrhage, traumatic brain injury, cardiac arrest, severe dementia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is a study to improve care by educating caregivers on the use of a certain medication and studying that process in a rigorous fashion.

Who is the study for?
The ED-AWARENESS-2 Trial is for adults over 18 who are receiving mechanical ventilation via an endotracheal tube in the emergency department (ED) and have been treated with neuromuscular blockers. It excludes those with neurological injuries that prevent assessment of awareness during paralysis, patients transferred out, or those who die before extubation.
What is being tested?
This trial tests whether educating ED clinicians on the use of succinylcholine—a short-acting neuromuscular blocker—over rocuronium can reduce risks associated with prolonged paralysis. The study uses a stepped wedge design across five sites to compare standard practices against this educational intervention.
What are the potential side effects?
While not explicitly stated, potential side effects may include typical reactions to succinylcholine such as muscle pain, increased heart rate, and rare but serious allergic reactions compared to longer-acting alternatives like rocuronium.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am on a breathing machine through a tube in my windpipe.
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I have been treated with a muscle relaxant for intubation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a brain condition that makes it hard to assess my pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The prevention of Awareness with Paralysis, as assessed by the modified Brice questionnaire.
Secondary study objectives
Depression and Anxiety
Health Related Quality of Life (QOL)
PTSD symptoms

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: After groupExperimental Treatment1 Intervention
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.
Group II: Before groupActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Education
2017
N/A
~4790

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
2,000 Previous Clinical Trials
2,341,220 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,796,742 Total Patients Enrolled
Brian Fuller, MDPrincipal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
1,776 Total Patients Enrolled

Media Library

Standard neuromuscular blocker practices (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05534243 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Before group, After group
Post-Traumatic Stress Disorder Clinical Trial 2023: Standard neuromuscular blocker practices Highlights & Side Effects. Trial Name: NCT05534243 — N/A
Standard neuromuscular blocker practices (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05534243 — N/A
~1756 spots leftby Mar 2027