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OpenTrials
Completed

NCT Number: NCT03643835

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

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Greensboro

Greensboro, North Carolina, 27412, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thermal Rehab Machine

Device

The Polar Breeze unit is a microenvironmental air-chiller. That means it is a single-pass air-conditioner capable of cooling external air

Other names: Polar Breeze

Forearm Ice Towels

Other

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

Primary outcomes

  1. Change in Internal Body Temperature

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Greensboro

Other

Collaborators

  • Statim Technologies, LLC

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 23, 2018
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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