ClinicalTrials.gg
RecruitingNCT07433036EDCPUpdated Feb 25, 2026

The Effectiveness of Emergency Room Protocols for Treating Hyperthermia

An interventional study of Passive cooling and Cooling packs in Hyperthermia, sponsored by University of Colorado, Colorado Springs. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by University of Colorado, Colorado Springs · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jul 2025, registered Feb 2026).
  • Started Jul 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Additionally, a negative control (passive cooling in air-conditioned room) and a positive control (cold water immersion).

02

Conditions studied

  • Hyperthermia

Keywords

  • Hyperthermia
  • Exercise
03

In context

Hyperthermia

256 studies on the registry are indexed under Hyperthermia; 73 are open to participants now.

This study's planned enrollment of 50 is above the median of 40 across 232 interventional studies indexed under Hyperthermia.

Browse Hyperthermia studies →

Lead sponsor

University of Colorado, Colorado Springs is the lead sponsor of 18 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Active, healthy individuals

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Passive cooling

    Participant lies supine in an air-conditioned room

    Procedure: Passive cooling

  • 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

  • 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

  • Experimental
    Body bag full of ice

    During recovery, participants are zipped into a body bag that is full of ice

    Procedure: Body bag cooling

  • Experimental
    Cold water immersion

    During recovery, participants are submerged to the neck in a cold water bath

    Procedure: Cold water immersion

Interventions

  • ProcedurePassive cooling

    During recovery, participants lie supine in an air-conditioned room

  • ProcedureCooling 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

    Also known as: Ice packs

  • ProcedureIce 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

  • ProcedureBody 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.

    Also known as: Ice bag

  • ProcedureCold water immersion

    During recovery, participants are submerged in a bath, up to their neck, in cold water water with ice

    Also known as: Ice water immersion

06

What researchers measure

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.

    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).

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Dec 2027, 29 months after the start.

Of 103 non-industry interventional studies with no phase under Hyperthermia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 29 months is above that.

Counting every sponsor, half of 108 studies reached it within 18 months; a quarter within 7 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2026
First posted
Feb 25, 2026
StartActual
Jul 1, 2025
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2028
Last update
Feb 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07433036
Lead sponsor
University of Colorado, Colorado Springs
Responsible party
Nathan Morris (Assistant professor, University of Colorado, Colorado Springs) — Principal investigator
First posted
Feb 25, 2026
Start date
Jul 1, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Feb 25, 2026

Study contacts

Nathan Morris, PhD
Contact
nmorris6@uccs.edu
719-255-4466

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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