The Effectiveness of Emergency Room Protocols for Treating Hyperthermia
ConditionHyperthermia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Colorado, Colorado Springs
About this trial
This study will help us as scientists and clinicians understand how effective commonly used cooling protocols in emergency departments are and which of the protocols is the most effective.
It consists of a single, approximately 1 hour preliminary session and five, approximately 3 hour experimental sessions, equaling an approximate 16 hour total time commitment.
The purpose of this research is to test the effectiveness of three cooling protocols.
1. Cooling packs 2. "Ice Sheets", which are bed sheets soaked in ice water, wrapped around the participant, while a fan blows air on them. 3. Body bag filled with ice, commonly used in emergency departments to treat hyperthermia
Additionally, a negative control (passive cooling in air-conditioned room) and a positive control (cold water immersion).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Active, healthy individuals
Disqualifiers
Pregnant or planning on becoming pregnant
Have a pacemaker
Currently taking any prescribed or over the counter medications or nutritional supplements known to influence thermoregulatory responses
Experience lingering pain from a previous musculoskeletal injury (i.e. knee, hip, or back pain)
Trial design
Design model
Crossover
Treatments tested in this trial
Passive cooling
Procedure/SurgeryDuring recovery, participants lie supine in an air-conditioned room
Cooling packs
Procedure/SurgeryDuring recovery, participants lie supine while ice packs are applied to both sides of the neck, both arm pits, and both sides of the groin
Ice sheets
Procedure/SurgeryDuring recovery, participants are wrapped in bed sheets that have been soaked in ice water, while an electric fan blows air across their body
Body bag cooling
Procedure/SurgeryDuring recovery, participants are placed in a body bag full of ice, and then have ice placed on top of their body, followed by zipping the body bag closed.
Cold water immersion
Procedure/SurgeryDuring recovery, participants are submerged in a bath, up to their neck, in cold water water with ice
Treatment groups
50 Participants
are divided into 5 treatment groupsGroup A: Passive coolingActive comparator 1 intervention
Group B: Cooling packsExperimental treatment 1 intervention
Group C: Ice sheetsExperimental treatment 1 intervention
Group D: Body bag full of iceExperimental treatment 1 intervention
Group E: Cold water immersionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rectal temperature cooling rate
Following termination of the exercise protocol, at a core temperature above 39 degrees Celcius, participants will be cooled until they reach a core temperature of 38 degrees Celcius. The cooling rate in degrees Celcius per minute, is the primary outcome.
Time frame
The measurement occurs immediately upon completion of the exercise protocol. Time itself is part of the outcome variable and will vary between participants (~3 to 40 min post exercise protocol).Sponsors and contacts
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Source ClinicalTrials.gov