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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights

ED-AWARENES II Trial 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.Check my eligibility
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.See study design
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.

ED-AWARENES II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
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.

ED-AWARENES II Trial 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

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

ED-AWARENES II 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
~4770

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,296,612 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,838 Previous Clinical Trials
47,848,564 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
Consciousness Research Study Groups: Before group, After group
Consciousness 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what areas is the clinical trial being implemented?

"Presently, recruitment is taking place at 4 different sites. These include Iowa City, Camden and Minneapolis in addition to another unspecified destination. It may be prudent for those interested in participating to opt for the closest center available so as to reduce their travel obligations."

Answered by AI

Are there any openings in this clinical investigation for new participants?

"Evidently, this medical trial is no longer accepting participants according to clinicaltrials.gov. The original posting was on July 1st 2023 and the most recent update was September 6th 2022. Although enrollment has closed for this research project, 449 other trials are currently enrolling patients at present time."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
Cooper University Hospital/Cooper Medical School of Rowan University
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've tried multiple medications and years of talk therapy. I sure hope this works.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How often would I be required to be in Camden?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
The ED-AWARENESS-2 Trial
Brian Fuller 2023. "The ED-AWARENESS-2 Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05534243.
All > Ptsd New York
~2060 spots leftby Mar 2027
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