Tarp Assisted Cooling of Hyperthermic Individuals

• Sponsor: State University of New York at Buffalo (Other)
• Overall Status: Completed
• CT.gov ID: NCT04095403
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Tarp Assisted Cooling; Other: passive cooling	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Randomized controlled trialRandomized controlled trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Tarp Assisted Cooling of Hyperthermic Individuals
• Actual Study Start Date: Feb 1, 2020
• Actual Primary Completion Date: Feb 14, 2022
• Actual Study Completion Date: Feb 14, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tarp assisted cooling Whole body cooling in a small amount of 20'C water.	Other: Tarp Assisted Cooling; Body cooling utilizing a tarp and water
Sham Comparator: Passive cooling Supine lying	Other: passive cooling; Supine rest.

Outcome Measures

Primary Outcome Measures

1. Cooling Rate [20 minutes post-exercise.]

   Internal body temperature reduction throughout cooling

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy

• Aerobic exercise at least twice weekly

Exclusion Criteria:

• History of exertional heat illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Research and Exercise in Special Environments	Buffalo	New York	United States	14214

Sponsors and Collaborators

• State University of New York at Buffalo

Investigators

• Principal Investigator: Riana R Pryor, PhD, University at Buffalo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Riana Pryor, Principal Investigator, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT04095403
• Other Study ID Numbers: STUDY00003727
• First Posted: Sep 19, 2019
• Last Update Posted: Feb 15, 2022
• Last Verified: Feb 1, 2022

• 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: No
• Keywords provided by Riana Pryor, Principal Investigator, State University of New York at Buffalo: Heat; Cooling
• Additional relevant MeSH terms: Hyperthermia; Fever

Study Results

No Results Posted as of Feb 15, 2022