Chemical Ice Packs for Cooling Hyperthermic Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
John Lissoway, Stanford University
ClinicalTrials.gov Identifier:
NCT01694290
First received: September 24, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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 Intervention
Heat Stroke, Heat Exhaustion
Other: Chemical Cold Pack

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Core body temperature cooling [ Time Frame: 35 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: August 2012
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: John Lissoway, Clinical Instructor of Emergency Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01694290     History of Changes
Other Study ID Numbers: 24308
Study First Received: September 24, 2012
Last Updated: September 24, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014