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Tarp Assisted Cooling of Hyperthermic Individuals

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tarp Assisted Cooling
passive cooling
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Heat, Cooling

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy
  • Aerobic exercise at least twice weekly

Exclusion Criteria:

  • History of exertional heat illness

Sites / Locations

  • Center for Research and Exercise in Special Environments

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Tarp assisted cooling

Passive cooling

Arm Description

Whole body cooling in a small amount of 20'C water.

Supine lying

Outcomes

Primary Outcome Measures

Cooling Rate
Internal body temperature reduction throughout cooling

Secondary Outcome Measures

Full Information

First Posted
September 13, 2019
Last Updated
February 14, 2022
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT04095403
Brief Title
Tarp Assisted Cooling of Hyperthermic Individuals
Official Title
Tarp Assisted Cooling of Hyperthermic Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
February 14, 2022 (Actual)
Study Completion Date
February 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Heat, Cooling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tarp assisted cooling
Arm Type
Experimental
Arm Description
Whole body cooling in a small amount of 20'C water.
Arm Title
Passive cooling
Arm Type
Sham Comparator
Arm Description
Supine lying
Intervention Type
Other
Intervention Name(s)
Tarp Assisted Cooling
Intervention Description
Body cooling utilizing a tarp and water
Intervention Type
Other
Intervention Name(s)
passive cooling
Intervention Description
Supine rest.
Primary Outcome Measure Information:
Title
Cooling Rate
Description
Internal body temperature reduction throughout cooling
Time Frame
20 minutes post-exercise.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Aerobic exercise at least twice weekly Exclusion Criteria: History of exertional heat illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riana R Pryor, PhD
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Research and Exercise in Special Environments
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate data can be shared upon request.

Learn more about this trial

Tarp Assisted Cooling of Hyperthermic Individuals

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