Back to resultsChemical Ice Packs for Cooling Hyperthermic Patients
Primary Purpose
Heat Stroke, Heat Exhaustion
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chemical Cold Pack
Sponsored by
About this trial
This is an interventional treatment trial for Heat Stroke, Heat Exhaustion
Eligibility Criteria
Inclusion Criteria:
- young healthy males > 18 years old with no active medical problems and able to run 10 km.
Exclusion Criteria:
- Active medical problems or inability to exercise for 45 minutes in a heated room.
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Chemical Ice packs to neck, groin, axillae
Chemical Ice Packs to cheeks, palms, soles
no chemical ice packs
Arm Description
Chemical ice packs will be changed out every 9 minutes
Chemical Ice packs will be changed out every 9 minutes
Outcomes
Primary Outcome Measures
Core body temperature cooling
Secondary Outcome Measures
Full Information
NCT ID
NCT01694290
First Posted
September 24, 2012
Last Updated
November 21, 2018
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT01694290
Brief Title
Chemical Ice Packs for Cooling Hyperthermic Patients
Official Title
Randomized Controlled Trial Assessing Effectiveness of Chemical Cold Packs Used on Various Skin Surfaces for Cooling Hyperthermic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heat Stroke, Heat Exhaustion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemical Ice packs to neck, groin, axillae
Arm Type
Experimental
Arm Description
Chemical ice packs will be changed out every 9 minutes
Arm Title
Chemical Ice Packs to cheeks, palms, soles
Arm Type
Experimental
Arm Description
Chemical Ice packs will be changed out every 9 minutes
Arm Title
no chemical ice packs
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Chemical Cold Pack
Primary Outcome Measure Information:
Title
Core body temperature cooling
Time Frame
35 minutes
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
young healthy males > 18 years old with no active medical problems and able to run 10 km.
Exclusion Criteria:
Active medical problems or inability to exercise for 45 minutes in a heated room.
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25771030
Citation
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.
Results Reference
result
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Chemical Ice Packs for Cooling Hyperthermic Patients
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