NCT01694290

Brief Summary

A common tool to cool people in the pre-hospital setting is the chemical ice pack. These are used by athletic trainers, EMS personnel, ER staff, and people in the prehosoital setting. The ability of these to cool a person has never been quantified, the efficiency and extent of cooling, as well as location of placement of ice packs is purely anecdotal. The purpose of this study is to determine whether strategically placed chemical ice packs will provide benefit to individuals subjected to heat stress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

11 months

First QC Date

September 24, 2012

Last Update Submit

November 21, 2018

Conditions

Heat Stroke, Heat Exhaustion

Outcome Measures

Primary Outcomes (1)

  • Core body temperature cooling

    35 minutes

Study Arms (3)

Chemical Ice packs to neck, groin, axillae

EXPERIMENTAL

Chemical ice packs will be changed out every 9 minutes

Other: Chemical Cold Pack

Chemical Ice Packs to cheeks, palms, soles

EXPERIMENTAL

Chemical Ice packs will be changed out every 9 minutes

Other: Chemical Cold Pack

no chemical ice packs

NO INTERVENTION

Interventions

Chemical Cold PackOTHER
Chemical Ice Packs to cheeks, palms, solesChemical Ice packs to neck, groin, axillae

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • young healthy males \> 18 years old with no active medical problems and able to run 10 km.

You may not qualify if:

  • Active medical problems or inability to exercise for 45 minutes in a heated room.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, United States

Location

Related Publications (1)

  • Lissoway JB, Lipman GS, Grahn DA, Cao VH, Shaheen M, Phan S, Weiss EA, Heller HC. Novel application of chemical cold packs for treatment of exercise-induced hyperthermia: a randomized controlled trial. Wilderness Environ Med. 2015 Jun;26(2):173-9. doi: 10.1016/j.wem.2014.11.006. Epub 2015 Mar 12.

    PMID: 25771030RESULT

MeSH Terms

Conditions

Heat StrokeHeat Exhaustion

Condition Hierarchy (Ancestors)

Heat Stress DisordersWounds and Injuries

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
Clinical Associate Professor of Emergency Medicine

Study Record Dates

First Submitted

September 24, 2012

First Posted

September 27, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

November 26, 2018

Record last verified: 2018-11

Locations

US(1)