Body Cooling in Hyperthermic Males and Females

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-20

Study Completion Date

2020-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Cryotherapy Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will complete three trials under three different body cooling conditions/interventions; passive cooling using the body's natural body cooling mechanisms, body cooling using cold water immersion, and cooling using the investigational thermal rehab machine.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Thermal rehab machine

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.

Group Type EXPERIMENTAL

Thermal Rehabilitation Machine

Intervention Type DEVICE

The Polar Breeze unit is a microenvironmental air-chiller. That means it is a single-pass air-conditioner capable of cooling external air

Cold Water Immersion

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).

Group Type ACTIVE_COMPARATOR

Cold Water Immersion

Intervention Type OTHER

Whole-body immersion in cold water.

Passive Cooling

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Cold Water Immersion

Whole-body immersion in cold water.

Intervention Type OTHER

Other Intervention Names

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Polar Breeze

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes