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Completed Not applicable Interventional Accepts healthy volunteers

Body Cooling in Hyperthermic Males and Females

ClinicalTrials.gov ID: NCT04190264

Public ClinicalTrials.gov record NCT04190264. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:03 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Efficacy of the Polar Breeze Thermal Rehabilitation Machine in Cooling Recreationally Active Males and Females Following Exercise-induced Hyperthermia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Exertional heat stroke (EHS) is an emergency medical condition that is prevalent in military soldiers, athletes, and laborers. It is diagnosed when the rectal temperature is above 40°C with the presence of central nervous dysfunction (altered mental status). The gold standard method of care for EHS is immediate onsite whole body cooling using cold-water immersion (cooling rates \>0.15°C•min-1), which is reported to have the highest cooling rate. In the treatment of EHS, selecting a cooling modality with a high cooling rate becomes crucial to minimize the time above the critical threshold of body temperature at 40°C to less than 30 minutes for the best chance of survival and to minimize the severity of prognosis. However, in situations where cold water immersion is not feasible (in certain military, firefighter, or other remote settings), other cooling modalities must be available that have a cooling capacity similar to that of cold-water immersion. In this proposed study, we aim to compare the cooling rates of the Polar Breeze® (developed by Polar Breeze ®, Clearwater, FL), cold-water immersion (the current gold standard for EHS treatment), and passive cooling in individuals with exercise-induced hyperthermia

Study identification

NCT ID
NCT04190264
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
12 participants

Conditions and interventions

Interventions

Device · Other

Eligibility (public fields only)

Age range
18 Years to 35 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 19, 2019
Primary completion
Mar 30, 2020
Completion
Mar 30, 2020
Last update posted
Apr 7, 2020

2019 – 2020

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of North Carolina at Greensboro Greensboro North Carolina 27412

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04190264, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 7, 2020 · Synced Sep 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04190264 live on ClinicalTrials.gov.

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