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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 is a NA study that has completed, run by University of North Carolina, Greensboro. The registered enrollment target is 12 participants.

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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

Interventions

  • OTHER Cold Water Immersion
  • DEVICE Thermal Rehabilitation Machine

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2019-11-20
Est. Completion 2020-03-31
Phase NA

What the Registry Record Tells You About NCT04190264

The ClinicalTrials.gov registry entry for NCT04190264 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Greensboro, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Cold Water Immersion is the first listed.

NCT04190264 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.