HealthyNCT04095403
Tarp Assisted Cooling of Hyperthermic Individuals
A study testing Tarp Assisted Cooling and passive cooling in people with Healthy, run by State University of New York at Buffalo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tarp Assisted Cooling and passive cooling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 14 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Aerobic exercise at least twice weekly
Who cannot join
- History of exertional heat illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Research and Exercise in Special Environments
Buffalo, New York, 14214
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Tarp Assisted Cooling, passive cooling
- Keywords
- Heat, Cooling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tarp Assisted CoolingOther
Body cooling utilizing a tarp and water
passive coolingOther
Supine rest.
| Study group | Role | What they receive |
|---|---|---|
| Tarp assisted cooling | Experimental | Whole body cooling in a small amount of 20'C water. Receives: Other: Tarp Assisted Cooling |
| Passive cooling | Sham comparator | Supine lying Receives: Other: passive cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cooling Rate
Internal body temperature reduction throughout cooling
Measured: 20 minutes post-exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Feb 2020
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riana Pryor, State University of New York at Buffalo
- Investigators
- Riana R Pryor, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095403
- Sponsor's protocol ID
- STUDY00003727
- Status last verified
- Feb 2022
- First submitted
- 13 Sep 2019
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate data can be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tarp Assisted Cooling of Hyperthermic Individuals
- ClinicalTrials.gov ID
- NCT04095403
- Acronym / sponsor ID
- STUDY00003727
- Conditions
- Healthy
- Keywords
- Heat, Cooling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Tarp assisted cooling | Experimental | Other: Tarp Assisted CoolingWhole body cooling in a small amount of 20'C water. |
| Passive cooling | Sham comparator | Other: passive coolingSupine lying |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- Aerobic exercise at least twice weekly
Key exclusion criteria (1 listed)
- History of exertional heat illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tarp Assisted CoolingBody cooling utilizing a tarp and water | Other | Tarp assisted cooling |
| passive coolingSupine rest. | Other | Passive cooling |
Primary outcome
Cooling Rate
Time frame: 20 minutes post-exercise.
Internal body temperature reduction throughout cooling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No. Aggregate data can be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riana R Pryor, PhD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tarp Assisted Cooling and passive cooling in people with Healthy, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cooling Rate (time frame: 20 minutes post-exercise.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.