50 Participants NeededMy employer runs this trial

Cooling Protocols for Hyperthermia

(EDCP Trial)

NM
Overseen ByNathan Morris, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Colorado Springs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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).

Are You a Good Fit for This Trial?

Inclusion Criteria

Active, healthy individuals

Exclusion Criteria

Pregnant or planning on becoming pregnant
Have a pacemaker
Use tobacco/nicotine products
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 hour
1 visit (in-person)

Preliminary Session

A single, approximately 1 hour preliminary session to prepare participants for the experimental sessions

1 hour
1 visit (in-person)

Experimental Sessions

Five experimental sessions to test the effectiveness of cooling protocols

15 hours
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Emergency Room Cooling Protocols

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Active Control

Group I: Ice sheetsExperimental Treatment1 Intervention
Group II: Cooling packsExperimental Treatment1 Intervention
Group III: Cold water immersionExperimental Treatment1 Intervention
Group IV: Body bag full of iceExperimental Treatment1 Intervention
Group V: Passive coolingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Colorado Springs

Lead Sponsor

Trials
20
Recruited
5,500+