NCT07743619

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.

Trial Health

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Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Sep 2026

Status
not yet recruiting

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

July 30, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 21, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

July 30, 2026

Last Update Submit

July 30, 2026

Conditions

Hyperthermia

Keywords

heat strokecoolingwaterexercise

Outcome Measures

Primary Outcomes (1)

  • Cooling Rate

    Internal body temperature reduction throughout cooling

    30 minutes post-exercise

Study Arms (2)

Phoenix Protocol First

ACTIVE COMPARATOR

Traditional cooling with ice and water trial first, followed by Recirculated water trial

Procedure: Recirculated waterProcedure: Phoenix protocol

Recirculated Cooling First

EXPERIMENTAL

Recirculated water trial first, followed by Traditional cooling with ice and water trial

Procedure: Recirculated waterProcedure: Phoenix protocol

Interventions

Recirculated waterPROCEDURE

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 FirstRecirculated Cooling First
Phoenix protocolPROCEDURE

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

Phoenix Protocol FirstRecirculated Cooling First

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HyperthermiaHeat StrokeMotor Activity

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and InjuriesBehavior

Central Study Contacts

Riana Pryor, PhD

CONTACT

7163489306rpryor@buffalo.edu

Study Design

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

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 4, 2026

Study Start (Estimated)

September 21, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

August 4, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

A spreadsheet of the cleaned, coded data for all variables will be shared with researchers upon reasonable written request. In addition to the dataset, a study protocol, data dictionary defining the variables, and data collection instruments can be shared.