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

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ClinicalTrials.gov Identifier: NCT03643835
Recruitment Status : Completed
First Posted : August 23, 2018
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
Statim Technologies, LLC
Information provided by (Responsible Party):
William Adams, University of North Carolina, Greensboro

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.

Condition or disease Intervention/treatment Phase
Cryotherapy Effect Device: Thermal Rehab Machine Other: Forearm Ice Towels Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Efficacy of an Investigational Thermal Rehab Machine on Body Cooling in Hyperthermic Individuals
Actual Study Start Date : September 17, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Rehabilitation

Arm Intervention/treatment
Experimental: Thermal rehab machine
Participants, following exercise-induced hyperthermia, will be cooled using a Thermal Rehab Machine (Polar Breeze, Statim Technologies, LLC, Clearwater Florida), which is a micro-environmental air chiller. The device will be placed over the subjects head and through trans pulmonary cooling, will cool the body.
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 Name: Polar Breeze

Active Comparator: Forearm Ice Towels
Participants, following exercise-induced hyperthermia, will be cooled using forearm ice towels. Cotton-blend towels will be doused in ice-water and then wrapped around participant's forearms (elbow to wrist). The towels will be rotated (re-wetted) every 2 minutes)
Other: Forearm Ice Towels
Towels that are wetted with ice water and wrapped around participants forearms (length of arm from wrist to elbow)

No Intervention: Passive Cooling
Participants, following exercise-induced hyperthermia, will undergo a period of passive rest to allow the body to cool via natural mechanisms of evaporation of sweat from the skin's surface and convection



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643835


Locations
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United States, North Carolina
University of North Carolina at Greensboro
Greensboro, North Carolina, United States, 27412
Sponsors and Collaborators
University of North Carolina, Greensboro
Statim Technologies, LLC
Investigators
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Principal Investigator: William M Adams, PhD University of North Carolina, Greensboro
  Study Documents (Full-Text)

Documents provided by William Adams, University of North Carolina, Greensboro:
Informed Consent Form  [PDF] August 15, 2018


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Responsible Party: William Adams, Assistant Professor, University of North Carolina, Greensboro
ClinicalTrials.gov Identifier: NCT03643835     History of Changes
Other Study ID Numbers: 18-0280
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Fever
Body Temperature Changes
Signs and Symptoms