NCT03643835

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of North Carolina, Greensboro · Academic / Other
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cryotherapy Effect

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-09-17
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2018-08-23
• Last updated: 2019-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study