The Effectiveness of Emergency Room Protocols for Treating Hyperthermia
EDCP
1 other identifier
interventional
50
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2025
CompletedFirst Submitted
Initial submission to the registry
February 10, 2026
CompletedFirst Posted
Study publicly available on registry
February 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
February 25, 2026
February 1, 2026
2.5 years
February 10, 2026
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rectal temperature cooling rate
Following termination of the exercise protocol, at a core temperature above 39 degrees Celcius, participants will be cooled until they reach a core temperature of 38 degrees Celcius. The cooling rate in degrees Celcius per minute, is the primary outcome.
The measurement occurs immediately upon completion of the exercise protocol. Time itself is part of the outcome variable and will vary between participants (~3 to 40 min post exercise protocol).
Study Arms (5)
Passive cooling
ACTIVE COMPARATORParticipant lies supine in an air-conditioned room
Cooling packs
EXPERIMENTALDuring recovery, cooling packs are applied on either side of the neck, both underarms, and both sides of the groin
Ice sheets
EXPERIMENTALDuring 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
Body bag full of ice
EXPERIMENTALDuring recovery, participants are zipped into a body bag that is full of ice
Cold water immersion
EXPERIMENTALDuring recovery, participants are submerged to the neck in a cold water bath
Interventions
During recovery, participants lie supine in an air-conditioned room
During recovery, participants lie supine while ice packs are applied to both sides of the neck, both arm pits, and both sides of the groin
During recovery, participants are wrapped in bed sheets that have been soaked in ice water, while an electric fan blows air across their body
During recovery, participants are placed in a body bag full of ice, and then have ice placed on top of their body, followed by zipping the body bag closed.
During recovery, participants are submerged in a bath, up to their neck, in cold water water with ice
Eligibility Criteria
You may qualify if:
- Active, healthy individuals
You may not qualify if:
- Pregnant or planning on becoming pregnant
- Have a pacemaker
- Currently taking any prescribed or over the counter medications or nutritional supplements known to influence thermoregulatory responses
- Experience lingering pain from a previous musculoskeletal injury (i.e. knee, hip, or back pain)
- Use tobacco/nicotine products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Colorado Springs
Colorado Springs, Colorado, 80918, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
February 10, 2026
First Posted
February 25, 2026
Study Start
July 1, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share