Tarp Assisted Cooling of Hyperthermic Individuals

NCT ID: NCT04095403

Last Updated: 2022-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-02-14

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tarp assisted cooling

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

Group Type EXPERIMENTAL

Tarp Assisted Cooling

Intervention Type OTHER

Body cooling utilizing a tarp and water

Passive cooling

Supine lying

Group Type SHAM_COMPARATOR

passive cooling

Intervention Type OTHER

Supine rest.

Interventions

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Tarp Assisted Cooling

Body cooling utilizing a tarp and water

Intervention Type OTHER

passive cooling

Supine rest.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Aerobic exercise at least twice weekly

Exclusion Criteria

* History of exertional heat illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Riana Pryor

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Riana R Pryor, PhD

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo

Locations

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Center for Research and Exercise in Special Environments

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00003727

Identifier Type: -

Identifier Source: org_study_id

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