<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01694290</url>
  </required_header>
  <id_info>
    <org_study_id>24308</org_study_id>
    <nct_id>NCT01694290</nct_id>
  </id_info>
  <brief_title>Chemical Ice Packs for Cooling Hyperthermic Patients</brief_title>
  <official_title>Randomized Controlled Trial Assessing Effectiveness of Chemical Cold Packs Used on Various Skin Surfaces for Cooling Hyperthermic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A common tool to cool people in the pre-hospital setting is the chemical ice pack. These are&#xD;
      used by athletic trainers, EMS personnel, ER staff, and people in the prehosoital setting.&#xD;
&#xD;
      The ability of these to cool a person has never been quantified, the efficiency and extent of&#xD;
      cooling, as well as location of placement of ice packs is purely anecdotal. The purpose of&#xD;
      this study is to determine whether strategically placed chemical ice packs will provide&#xD;
      benefit to individuals subjected to heat stress.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Core body temperature cooling</measure>
    <time_frame>35 minutes</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Heat Stroke, Heat Exhaustion</condition>
  <arm_group>
    <arm_group_label>Chemical Ice packs to neck, groin, axillae</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chemical ice packs will be changed out every 9 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemical Ice Packs to cheeks, palms, soles</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chemical Ice packs will be changed out every 9 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no chemical ice packs</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chemical Cold Pack</intervention_name>
    <arm_group_label>Chemical Ice Packs to cheeks, palms, soles</arm_group_label>
    <arm_group_label>Chemical Ice packs to neck, groin, axillae</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  young healthy males &gt; 18 years old with no active medical problems and able to run 10&#xD;
             km.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active medical problems or inability to exercise for 45 minutes in a heated room.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>25771030</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Grant S Lipman</investigator_full_name>
    <investigator_title>Clinical Associate Professor of Emergency Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heat Stroke</mesh_term>
    <mesh_term>Heat Exhaustion</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01694290
org study id: 24308
nct id: NCT01694290
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Core body temperature cooling
time frame: 35 minutes
arm group label: Chemical Ice packs to neck, groin, axillae
arm group type: Experimental
description: Chemical ice packs will be changed out every 9 minutes
arm group label: Chemical Ice Packs to cheeks, palms, soles
arm group type: Experimental
description: Chemical Ice packs will be changed out every 9 minutes
arm group label: no chemical ice packs
arm group type: No Intervention
intervention type: Other
intervention name: Chemical Cold Pack
arm group label: Chemical Ice Packs to cheeks, palms, soles
arm group label: Chemical Ice packs to neck, groin, axillae
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
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.
PMID: 25771030
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Grant S Lipman
investigator title: Clinical Associate Professor of Emergency Medicine
mesh term: Heat Stroke
mesh term: Heat Exhaustion