Body Cooling in Hyperthermic Males and Females

University of North Carolina, Greensboro

Status: Completed

Conditions: Cryotherapy Effect

Treatments: Device: Thermal Rehabilitation Machine; Other: Cold Water Immersion

Study type: Interventional

Funder types: Other

Identifiers

NCT04190264

A20-0085

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Thermal rehab machine

Experimental group

Description:

Participants, following exercise-induced hyperthermia, will be cooled using a Thermal Rehab Machine (Polar Breeze, Statim Technologies, LLC, Clearwater Florida), which is a micro-environmental air chiller. The device will be placed over the subjects head and through trans pulmonary cooling, will cool the body.

Treatment:

Device: Thermal Rehabilitation Machine

Cold Water Immersion

Active Comparator group

Description:

Participants, following exercise-induced hyperthermia, will be cooled using cold water immersion. Participants will be immersed up to their chest in cold water (\~50-55 Degrees Fahrenheit).

Treatment:

Other: Cold Water Immersion

Passive Cooling

No Intervention group

Description:

Participants, following exercise-induced hyperthermia, will undergo a period of passive rest to allow the body to cool via natural mechanisms of evaporation of sweat from the skin's surface and convection