The Effectiveness of Emergency Room Protocols for Treating Hyperthermia

Part of paid clinical trials in Colorado Springs, Colorado.

Sponsor
University of Colorado, Colorado Springs
Study ID
NCT07433036
Status
Recruiting
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Conditions

  • Hyperthermia

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Passive cooling — PROCEDURE
    During recovery, participants lie supine in an air-conditioned room
  • Cooling packs — PROCEDURE
    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
  • Ice sheets — PROCEDURE
    During recovery, participants are wrapped in bed sheets that have been soaked in ice water, while an electric fan blows air across their body
  • Body bag cooling — PROCEDURE
    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.
  • Cold water immersion — PROCEDURE
    During recovery, participants are submerged in a bath, up to their neck, in cold water water with ice

Study Details

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).

Key Dates

Start date
Jul 1, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Passive cooling
    Participant lies 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
  • 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
  • Experimental: Body bag full of ice
    During recovery, participants are zipped into a body bag that is full of ice
  • Experimental: Cold water immersion
    During recovery, participants are submerged to the neck in a cold water bath

Primary Outcome Measure

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). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Colorado SpringsColorado SpringsColorado80918
Nathan Morris, PhD
[email protected]
719-255-4466

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By research site
University of Colorado Colorado Springs· Colorado Springs, CO

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