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

• Sponsor: University of North Carolina, Greensboro (Other)
• Overall Status: Completed
• CT.gov ID: NCT03643835
• Collaborator: Statim Technologies, LLC (Other)
• Enrollment: 14
• Location: 1
• Arms: 3
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 4.1

Study Details

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	N/A

Study Design

• Study Type: Interventional
• 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.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: Sep 17, 2018
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Dec 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 Names: 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 [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

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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)

• Informed Consent Form - Aug 15, 2018

More Information

Publications

None provided.

• Responsible Party: William Adams, Assistant Professor, University of North Carolina, Greensboro
• ClinicalTrials.gov Identifier: NCT03643835
• Other Study ID Numbers: 18-0280
• First Posted: Aug 23, 2018
• Last Update Posted: Apr 18, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of Apr 18, 2019