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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04190264
Other study ID # A20-0085
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2019
Est. completion date March 31, 2020

Study information

Verified date April 2020
Source University of North Carolina, Greensboro
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date March 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- males and females between the ages of 18-35.

- recreationally active (regularly exercise at a minimum of 4-5 times per week for greater than 30 minutes per session)

Exclusion Criteria:

- chronic health problems

- fever or current illness at the time of testing

- history of cardiovascular, metabolic, or respiratory disease

- current musculoskeletal injury that limits physical activity

- history of exertional heat illness in the past three years

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Thermal Rehabilitation Machine
The Polar Breeze unit is a microenvironmental air-chiller. That means it is a single-pass air-conditioner capable of cooling external air
Other:
Cold Water Immersion
Whole-body immersion in cold water.

Locations

Country Name City State
United States University of North Carolina at Greensboro Greensboro North Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of North Carolina, Greensboro

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Internal Body Temperature The rate at which body temperature is reduced during whole body cooling following exercise-induced hyperthermia. 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 minutes post onset of cooling
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