NCT04095403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2022

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

September 13, 2019

Last Update Submit

February 14, 2022

Conditions

Keywords

HeatCooling

Outcome Measures

Primary Outcomes (1)

  • Cooling Rate

    Internal body temperature reduction throughout cooling

    20 minutes post-exercise.

Study Arms (2)

Tarp assisted cooling

EXPERIMENTAL

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

Other: Tarp Assisted Cooling

Passive cooling

SHAM COMPARATOR

Supine lying

Other: passive cooling

Interventions

Body cooling utilizing a tarp and water

Tarp assisted cooling

Supine rest.

Passive cooling

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Aerobic exercise at least twice weekly

You may not qualify if:

  • History of exertional heat illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Research and Exercise in Special Environments

Buffalo, New York, 14214, United States

Location

Study Officials

  • Riana R Pryor, PhD

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2019

First Posted

September 19, 2019

Study Start

February 1, 2020

Primary Completion

February 14, 2022

Study Completion

February 14, 2022

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Aggregate data can be shared upon request.

Locations