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

Not Applicable

Completed

• Conditions: Cryotherapy Effect
• Interventions: Device: Thermal Rehab Machine; Other: Forearm Ice Towels

• Registration Number: NCT03643835
• Lead Sponsor: University of North Carolina, Greensboro

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, 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-15
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-23
• Study Start: 2018-09-17
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

Inclusion Criteria

• 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)

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Thermal rehab machine	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.
Forearm Ice Towels	Forearm Ice Towels	Participants, following exercise-induced hyperthermia, will be cooled using forearm ice towels. Cotton-blend towels will be doused in ice-water and then wrapped around participant's forearms (elbow to wrist). The towels will be rotated (re-wetted) every 2 minutes)

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of North Carolina at Greensboro; 🇺🇸 Greensboro, North Carolina, United States