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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03643835
Enrollment
14
Registered
2018-08-23
Start date
2018-09-17
Completion date
2018-12-31
Last updated
2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryotherapy Effect

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.

Interventions

DEVICEThermal 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

OTHERForearm Ice Towels

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

Sponsors

Statim Technologies, LLC
CollaboratorUNKNOWN
University of North Carolina, Greensboro
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Intervention model description

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 forearm ice towels, and cooling using the investigational thermal rehab machine.

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Internal Body Temperature0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 minutes post onset of coolingThe rate at which body temperature is reduced during whole body cooling following exercise-induced hyperthermia.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026