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NCT04095403 Clinical Trial

Tarp Assisted Cooling of Hyperthermic Individuals

Healthy Clinical Trial

Official title:
Tarp Assisted Cooling of Hyperthermic Individuals

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04095403
Other study ID # STUDY00003727
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date February 14, 2022

Study information
Verified date February 2022
Source State University of New York at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized controlled trial exploring the difference in cooling rates between two treatments: 1) tarp-assisted cooling and 2) the standard of care for heat stroke treatment in the wilderness.

Description:

This is a randomized controlled trial exploring the difference in cooling rates between two treatments: 1) tarp-assisted cooling and 2) the standard of care for heat stroke treatment in the wilderness. 12 healthy participants (6 males, 6 females) will participate. Visit 1 will be a screening visit, consisting of informed consent followed by completion of questionnaires to determine study eligibility. Participants will have their resting vital signs (heart rate, blood pressure), height, weight, and percent body fat measured. Visits 2 and 3 will be experimental trials. Participants will complete a treadmill protocol consisting of brisk walking wearing a weighted backpack (40 lb) until core temperature reaches 40.0°C. Upon completion of exercise, participants will exit the environmental chamber and be cooled in one of two ways in a randomized, counterbalanced manner: 1) tarp-assisted cooling or 2) Standard of Care. Cooling will take place for 20 minutes.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date February 14, 2022
Est. primary completion date February 14, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria: - Healthy - Aerobic exercise at least twice weekly Exclusion Criteria: - History of exertional heat illness

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Tarp Assisted Cooling
Body cooling utilizing a tarp and water
• passive cooling
Supine rest.

Locations
Country Name City State
United States Center for Research and Exercise in Special Environments Buffalo New York

Sponsors (1)
Lead Sponsor Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cooling Rate Internal body temperature reduction throughout cooling 20 minutes post-exercise.
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