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NCT Number: NCT07743619

Rapid Cool: Heat Stroke Treatment

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.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Recirculated water

Procedure

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

Phoenix protocol

Procedure

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

Primary outcomes

  1. Cooling Rate

    Time frame: 30 minutes post-exercise

    Internal body temperature reduction throughout cooling

Study contacts

Contact information is provided by the study sponsor or research team.

Riana Pryor, PhD

CONTACT

[email protected]

7163489306

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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