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Rapid Cool: Heat Stroke Treatment

Rapid Cool: Heat Stroke Treatment

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07743619
Enrollment
20
Registered
2026-08-04
Start date
2026-09-21
Completion date
2027-08-31
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperthermia

Keywords

heat stroke, cooling, water, exercise

Brief summary

Hot climates such as in Phoenix, AZ commonly have individuals experiencing heat stroke, a life-threatening medical emergency. The dangerously high body temperature can result in death if not treated immediately with rapid body cooling. Rapid core temperature reduction within 30 min of diagnosis results in 100% survival and positive outcomes. While this is easily achieved with whole-body cold water immersion, this modality is not feasible in an ambulance. The Phoenix emergency medical services protocol consists of lying the patient on a large volume of ice. While this is somewhat effective, this cooling strategy results in a sub-optimal cooling rate, difficulty obtaining this large volume of ice, and a very wet ambulance as the ice melts. Recently, a company created a cooling strategy that utilizes a small amount of ice and a small amount of recirculated water to keep the patient cool. The purpose of this study is to determine the core temperature cooling rate of this cooling strategy and compare it to the cooling rate of the currently used Phoenix protocol.

Interventions

PROCEDURERecirculated water

Participants will lie in a thick plastic bag with ice and water, placed on top of a cot, with the water circulated using a pump

PROCEDUREPhoenix protocol

Participants will lie in a thick plastic bag filled with ice and water, placed on top of a cot

Sponsors

State University of New York at Buffalo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes

Inclusion criteria

1. Adult participant (18 - 39 years old) 2. Body mass index (BMI) 18 - 30 kg/m2 3. At least moderate intensity aerobic exercise ≥60 min per week 4. Participant is able and willing to follow study procedures

Exclusion criteria

1. History of cardiovascular, neurological, metabolic, pulmonary, renal, gastrointestinal, or autoimmune disease 2. Taking prescription medication (with exception of psychiatric medication) 3. If taking a psychiatric medication, the dosage has changed within the month prior to first study visit 4. Cannot abstain from taking over-the-counter medications or supplements for 24 hours before study visits (with exception of vitamins) 5. Resting systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥90 mmHg 6. Resting heart rate of ≥100 beats per minute 7. Regular smoker of cigarettes or has regularly smoked in the past year 8. Musculoskeletal injury/condition that negatively impacts the protocol 9. History of heat illness that resulted in a visit to a medical center in the past 2 years 10. Has donated blood or plasma in the past 3 months 11. Has taken antibiotics or corticosteroids within 4 weeks of enrollment 12. Has a medical implant device such as a pacemaker, patient monitoring system, or metallic implant 13. Has a full or partially amputated limb 14. Pregnant or breastfeeding 15. Study physician or PI discretion based on any other medical condition or medication

Design outcomes

Primary

MeasureTime frameDescription
Cooling Rate30 minutes post-exerciseInternal body temperature reduction throughout cooling

Contacts

CONTACTRiana Pryor, PhD
rpryor@buffalo.edu7163489306

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026