Cooling Protocols for Hyperthermia
(EDCP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will help us as scientists and clinicians understand how effective commonly used cooling protocols in emergency departments are and which of the protocols is the most effective.
It consists of a single, approximately 1 hour preliminary session and five, approximately 3 hour experimental sessions, equaling an approximate 16 hour total time commitment.
The purpose of this research is to test the effectiveness of three cooling protocols.
1. Cooling packs
2. "Ice Sheets", which are bed sheets soaked in ice water, wrapped around the participant, while a fan blows air on them.
3. Body bag filled with ice, commonly used in emergency departments to treat hyperthermia
Additionally, a negative control (passive cooling in air-conditioned room) and a positive control (cold water immersion).
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preliminary Session
A single, approximately 1 hour preliminary session to prepare participants for the experimental sessions
Experimental Sessions
Five experimental sessions to test the effectiveness of cooling protocols
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Emergency Room Cooling Protocols
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Active Control
During recovery, participants lie supine and are wrapped in bed sheets that have been soaked in ice water, then have a fan directed towards them while cooling
During recovery, cooling packs are applied on either side of the neck, both underarms, and both sides of the groin
During recovery, participants are submerged to the neck in a cold water bath
During recovery, participants are zipped into a body bag that is full of ice
Participant lies supine in an air-conditioned room
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Colorado Springs
Lead Sponsor
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