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

Cryotherapy Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03643835
• Other study ID #: 18-0280
• Status: Completed
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: University of North Carolina, Greensboro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cryotherapy Effect
• Fever

Intervention

Device:
• Thermal Rehab Machine
The Polar Breeze unit is a microenvironmental air-chiller. That means it is a single-pass air-conditioner capable of cooling external air

Other:
• Forearm Ice Towels
Towels that are wetted with ice water and wrapped around participants forearms (length of arm from wrist to elbow)

Locations

Country	Name	City	State
United States	University of North Carolina at Greensboro	Greensboro	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Greensboro	Statim Technologies, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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