HyperthermiaEDCPNCT07433036
The Effectiveness of Emergency Room Protocols for Treating Hyperthermia
A study testing Passive cooling, Cooling packs and Ice sheets in people with Hyperthermia, run by University of Colorado, Colorado Springs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthermia
- What is being tested?
- Passive cooling, Cooling packs and Ice sheets
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active, healthy individuals
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Colorado Springs
Colorado Springs, Colorado, 80918
Nathan Morris, PhD, 719-255-4466, nmorris6@uccs.edu
About this study
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.
Read more
The purpose of this research is to test the effectiveness of three cooling protocols.
- Cooling packs
- "Ice Sheets", which are bed sheets soaked in ice water, wrapped around the participant, while a fan blows air on them.
- 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).
- Conditions
- Hyperthermia
- Being tested
- Passive cooling, Cooling packs, Ice sheets, Body bag cooling, Cold water immersion
- Keywords
- Hyperthermia, Exercise
- Medical subject headings
- Hyperthermia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive coolingProcedure or surgery
During recovery, participants lie supine in an air-conditioned room
Cooling packsProcedure or surgery
Also called Ice 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
Ice sheetsProcedure or surgery
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 coolingProcedure or surgery
Also called Ice bag
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 immersionProcedure or surgery
Also called Ice water immersion
During recovery, participants are submerged in a bath, up to their neck, in cold water water with ice
| Study group | Role | What they receive |
|---|---|---|
| Passive cooling | Active comparator | Participant lies supine in an air-conditioned room Receives: Procedure: Passive cooling |
| Cooling packs | Experimental | During recovery, cooling packs are applied on either side of the neck, both underarms, and both sides of the groin Receives: Procedure: Cooling packs |
| Ice sheets | Experimental | 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 Receives: Procedure: Ice sheets |
| Body bag full of ice | Experimental | During recovery, participants are zipped into a body bag that is full of ice Receives: Procedure: Body bag cooling |
| Cold water immersion | Experimental | During recovery, participants are submerged to the neck in a cold water bath Receives: Procedure: Cold water immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Colorado Springs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathan Morris, University of Colorado, Colorado Springs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433036
- Sponsor's protocol ID
- 2025-088-HYBL
- Acronym
- EDCP
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Emergency Room Protocols for Treating Hyperthermia
- ClinicalTrials.gov ID
- NCT07433036
- Acronym / sponsor ID
- EDCP / 2025-088-HYBL
- Conditions
- Hyperthermia
- Keywords
- Hyperthermia, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Colorado, Colorado SpringsUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Cooling packs
- "Ice Sheets", which are bed sheets soaked in ice water, wrapped around the participant, while a fan blows air on them.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Passive cooling | Active comparator | Procedure: Passive coolingParticipant lies supine in an air-conditioned room |
| Cooling packs | Experimental | Procedure: Cooling packsDuring recovery, cooling packs are applied on either side of the neck, both underarms, and both sides of the groin |
| Ice sheets | Experimental | Procedure: Ice sheetsDuring 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 | Experimental | Procedure: Body bag coolingDuring recovery, participants are zipped into a body bag that is full of ice |
| Cold water immersion | Experimental | Procedure: Cold water immersionDuring recovery, participants are submerged to the neck in a cold water bath |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active, healthy individuals
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive coolingDuring recovery, participants lie supine in an air-conditioned room | Procedure or surgery | Passive cooling |
| Cooling packsAlso: Ice packsDuring 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 or surgery | Cooling packs |
| Ice sheetsDuring recovery, participants are wrapped in bed sheets that have been soaked in ice water, while an electric fan blows air across their body | Procedure or surgery | Ice sheets |
| Body bag coolingAlso: Ice bagDuring 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 or surgery | Body bag full of ice |
| Cold water immersionAlso: Ice water immersionDuring recovery, participants are submerged in a bath, up to their neck, in cold water water with ice | Procedure or surgery | Cold water immersion |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive cooling, Cooling packs and Ice sheets in people with Hyperthermia, run by University of Colorado, Colorado Springs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan Morris, PhD (719-255-4466, nmorris6@uccs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.