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NCT03643835 · ClinicalTrials.gov registry record · NA
Efficacy of an Investigational Thermal Rehab Machine on Body Cooling in Hyperthermic Individuals
A NA study, sponsored by University of North Carolina, Greensboro.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT03643835: Completed NA study, sponsored by University of North Carolina, Greensboro.
NCT03643835 is a NA study that has completed, run by University of North Carolina, Greensboro. The registered enrollment target is 14 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
NCT03643835, a NA study, has completed, sponsored by University of North Carolina, Greensboro.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 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, the investigators aim to examine the cooling rates of the Polar Breeze® device (developed by Statim Technologies, LLC, Clearwater, FL) compared to rotating ice towels, a cooling method often recommended by sports medicine professionals as an alternative to cold-water immersion, and passive rest in participants with exercise-induced hyperthermia.
Primary Outcome
The rate at which body temperature is reduced during whole body cooling following exercise-induced hyperthermia.
Interventions
- DEVICE Thermal Rehab Machine
- OTHER Forearm Ice Towels
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-09-17 |
| Est. Completion | 2018-12-31 |
| Phase | NA |
What the finished NCT03643835 record still lists
NCT03643835 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 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 Thermal Rehab Machine is the first listed.
NCT03643835 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03643835 about?
NCT03643835 is a clinical study titled "Efficacy of an Investigational Thermal Rehab Machine on Body Cooling in Hyperthermic Individuals". 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 NCT03643835?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2018-09-17. Estimated completion is 2018-12-31.
What interventions are being tested in trial NCT03643835?
The interventions under investigation include: Thermal Rehab Machine (DEVICE), Forearm Ice Towels (OTHER).
Who is sponsoring clinical trial NCT03643835?
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 NCT03643835's enrollment target sits among peer trials
14 1909th of 2000 higher than 90 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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