The Effectiveness of Emergency Room Protocols for Treating Hyperthermia (EDCP)

February 18, 2026 updated by: Nathan Morris, University of Colorado, Colorado Springs

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
        • Recruiting
        • University of Colorado Colorado Springs
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Active, healthy individuals

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Passive cooling
Participant lies supine in an air-conditioned room
Procedure: Passive cooling
During recovery, participants lie supine in an air-conditioned room
Experimental: Cooling packs
During recovery, cooling packs are applied on either side of the neck, both underarms, and both sides of the groin
Procedure: Cooling packs
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
Other Names:
  • Ice packs
Experimental: Ice sheets
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
Procedure: Ice sheets
During recovery, participants are wrapped in bed sheets that have been soaked in ice water, while an electric fan blows air across their body
Experimental: Body bag full of ice
During recovery, participants are zipped into a body bag that is full of ice
Procedure: Body bag cooling
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.
Other Names:
  • Ice bag
Experimental: Cold water immersion
During recovery, participants are submerged to the neck in a cold water bath
Procedure: Cold water immersion
During recovery, participants are submerged in a bath, up to their neck, in cold water water with ice
Other Names:
  • Ice water immersion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rectal temperature cooling rate
Time Frame: 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).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Colorado Springs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-088-HYBL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperthermia

Clinical Trials on Passive cooling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe