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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• 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

More Information

• Responsible Party: William Adams, Assistant Professor, University of North Carolina, Greensboro
• ClinicalTrials.gov Identifier: NCT03643835
• Other Study ID Numbers: 18-0280
• First Posted: August 23, 2018
• Last Update Posted: April 18, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Hyperthermia; Fever; Body Temperature Changes; Heat Stress Disorders; Wounds and Injuries