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Recruiting NCT07433036

The Effectiveness of Emergency Room Protocols for Treating Hyperthermia

No phase Interventional Hyperthermia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Passive cooling, Cooling packs, Ice sheets, Body bag cooling.
Who it may be relevant to
Registry conditions: Hyperthermia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Interventions

  • Procedure Passive cooling
    During recovery, participants lie supine in an air-conditioned room
  • 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
  • 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
  • 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.
  • Procedure Cold water immersion
    During recovery, participants are submerged in a bath, up to their neck, in cold water water with ice

Primary outcome measures

  • 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).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Colorado Colorado Springs — Colorado Springs

Identifiers

NCT: NCT07433036 · 2025-088-HYBL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗