Body Cooling in Hyperthermic Males and Females

NCT04190264 | Completed

• 1 other identifier: A20-0085
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cryotherapy Effect

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Thermal rehab machine

EXPERIMENTAL

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.

Device: Thermal Rehabilitation Machine

Cold Water Immersion

ACTIVE COMPARATOR

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).

Other: Cold Water Immersion

Passive Cooling

NO INTERVENTION

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

Interventions

Thermal Rehabilitation Machine DEVICE

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

Also known as: Polar Breeze

Thermal rehab machine

Cold Water Immersion OTHER

Whole-body immersion in cold water.

Cold Water Immersion

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

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

Sponsors & Collaborators

• University of North Carolina, Greensboro: lead

Study Sites (1)

University of North Carolina at Greensboro

Greensboro, North Carolina, 27412, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 9, 2019
• Study Start: November 20, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)