Efficacy of an Investigational Thermal Rehab Machine on Body Cooling in Hyperthermic Individuals

Completed · Not applicable

Conditions studied: Cryotherapy Effect

In brief

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.

Key facts

Study ID

NCT03643835

Run by

University of North Carolina, Greensboro

People needed

14

Starts

2018-09-17

Expected to finish

2018-12-31

Last updated by the study team

2019-04-18

Who can join

Age: 18 and older, up to 35. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• male 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)

You may not qualify if…

• 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.

Where it is running

• University of North Carolina at Greensboro — Greensboro, North Carolina, United States

Full record on ClinicalTrials.gov

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