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Chemical Ice Packs for Cooling Hyperthermic Patients

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ClinicalTrials.gov Identifier: NCT01694290
Recruitment Status : Unknown
Verified September 2012 by John Lissoway, Stanford University.
Recruitment status was:  Recruiting
First Posted : September 27, 2012
Last Update Posted : September 27, 2012
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Heat Stroke, Heat Exhaustion Other: Chemical Cold Pack

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Assessing Effectiveness of Chemical Cold Packs Used on Various Skin Surfaces for Cooling Hyperthermic Patients
Study Start Date : August 2012
Estimated Primary Completion Date : July 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: Chemical Ice packs to neck, groin, axillae
Chemical ice packs will be changed out every 9 minutes
Other: Chemical Cold Pack
Experimental: Chemical Ice Packs to cheeks, palms, soles
Chemical Ice packs will be changed out every 9 minutes
Other: Chemical Cold Pack
No Intervention: no chemical ice packs


Outcome Measures

Primary Outcome Measures :
  1. Core body temperature cooling [ Time Frame: 35 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694290


Contacts
Contact: John B Lissoway, MD johnlissoway@gmail.com
Contact: Grant Lipman, MD grantlip@hotmail.com

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States
Contact: John Lissoway, MD       johnlissoway@gmail.com   
Sponsors and Collaborators
Stanford University
More Information

Responsible Party: John Lissoway, Clinical Instructor of Emergency Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01694290     History of Changes
Other Study ID Numbers: 24308
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: September 27, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Fever
Heat Stroke
Heat Exhaustion
Body Temperature Changes
Signs and Symptoms
Heat Stress Disorders
Wounds and Injuries