Clinical Trials Directory

Trials / Completed

CompletedNCT04190264

Body Cooling in Hyperthermic Males and Females

Efficacy of the Polar Breeze Thermal Rehabilitation Machine in Cooling Recreationally Active Males and Females Following Exercise-induced Hyperthermia

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
12 (actual)
Sponsor
University of North Carolina, Greensboro · Academic / Other
Sex
All
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, 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

Interventions

TypeNameDescription
DEVICEThermal Rehabilitation MachineThe Polar Breeze unit is a microenvironmental air-chiller. That means it is a single-pass air-conditioner capable of cooling external air
OTHERCold Water ImmersionWhole-body immersion in cold water.

Timeline

Start date
2019-11-20
Primary completion
2020-03-31
Completion
2020-03-31
First posted
2019-12-09
Last updated
2020-04-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04190264. Inclusion in this directory is not an endorsement.