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NCT04190264 · ClinicalTrials.gov registry record · NA
Body Cooling in Hyperthermic Males and Females
A NA study, sponsored by University of North Carolina, Greensboro.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT04190264: Completed NA study, sponsored by University of North Carolina, Greensboro.
NCT04190264 is a NA study that has completed, run by University of North Carolina, Greensboro. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04190264, a NA study, has completed, sponsored by University of North Carolina, Greensboro.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
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
Primary Outcome
The rate at which body temperature is reduced during whole body cooling following exercise-induced hyperthermia.
Interventions
- OTHER Cold Water Immersion
- DEVICE Thermal Rehabilitation Machine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-11-20 |
| Est. Completion | 2020-03-31 |
| Phase | NA |
What the finished NCT04190264 record still lists
NCT04190264 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Cold Water Immersion is the first listed.
NCT04190264 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04190264 about?
NCT04190264 is a clinical study titled "Body Cooling in Hyperthermic Males and Females". 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 ...
What is the current status of trial NCT04190264?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2019-11-20. Estimated completion is 2020-03-31.
What interventions are being tested in trial NCT04190264?
The interventions under investigation include: Cold Water Immersion (OTHER), Thermal Rehabilitation Machine (DEVICE).
Who is sponsoring clinical trial NCT04190264?
This trial is sponsored by University of North Carolina, Greensboro, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04190264's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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