<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/NCT04410068</url>
  </required_header>
  <id_info>
    <org_study_id>2019-8860-I</org_study_id>
    <nct_id>NCT04410068</nct_id>
  </id_info>
  <brief_title>Comparison of Electric Heating Pad Versus Forced-air Warming to Prevent Inadvertent Perioperative Hypothermia</brief_title>
  <official_title>Comparison of Electric Heating Pad Versus Forced-air Warming to Prevent Inadvertent Perioperative Hypothermia: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Parc de Salut Mar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Parc de Salut Mar</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare core body temperature after laparoscopic surgery using the forced air heating system&#xD;
      versus the WARMTAC® (a carbon fiber electric blanket).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to prevent perioperative hypothermia, we will compare two different heating sistems,&#xD;
      one of them is an electric pad made with carbon fiber and the other system is a forced-air&#xD;
      blanket. Both of them will be situated under the patient during all the laparoscopic surgey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 23, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Core body temperature</measure>
    <time_frame>through study completion, an average of 12 months</time_frame>
    <description>temperatured recorded in esophagus</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rescues number</measure>
    <time_frame>through study completion, an average of 12 months</time_frame>
    <description>Compare number of rescues required by each system to avoid mild hypothermia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>skin lesions</measure>
    <time_frame>through study completion, an average of 12 months</time_frame>
    <description>Detect possible skin complications related to heating</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Temperature Change, Body</condition>
  <condition>Hypothermia; Anesthesia</condition>
  <arm_group>
    <arm_group_label>Electrical heating pad</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electrical heating pad (WARMTAC device). Patients will be randomized to one arm.&#xD;
In this arm, the WARMTAC device will be conected and warmed to 41 degrees before patients lay down.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>forced-air warming device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Forced-air warming device (3M device). In this arm, the 3M blanket will be conected to forced-air machine and warmed to 41 degrees before patients lay down.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WARMTAC</intervention_name>
    <description>Randomization to one of the arms previous to surgery.</description>
    <arm_group_label>Electrical heating pad</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3M Bair Hugger</intervention_name>
    <description>Randomization to one of the arms previous to surgery.</description>
    <arm_group_label>forced-air warming device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years of age at the time of the preoperative visit.&#xD;
&#xD;
          -  Patients who will undergo elective laparoscopic surgery&#xD;
&#xD;
          -  Patients who sign the informed consent indicating that they have been informed of all&#xD;
             relevant aspects of the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Axillary temperature&gt; 37.5ºC&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Dysfunction of the autonomic system&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mireia Chanza, Physician</last_name>
    <role>Principal Investigator</role>
    <affiliation>PSMar</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mirea Chanza</last_name>
    <phone>0034667550215</phone>
    <email>mchanza@parcdesalutmar.cat</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08029</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>LLUIS GALLART GALLEGO</last_name>
      <phone>680986184</phone>
      <email>lluis@gallart.cat</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Calvo Vecino JM, Casans Frances R, Ripolles Melchor J, Marin Zaldivar C, Gomez Rios MA, Perez Ferrer A, Zaballos Bustingorri JM, Abad Gurumeta A; Grupo de trabajo de la GPC de Hipotermia Perioperatoria No Intencionada de la SEDAR. Clinical practice guideline. Unintentional perioperative hypothermia. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Dec;65(10):564-588. doi: 10.1016/j.redar.2018.07.006. Epub 2018 Nov 15. English, Spanish.</citation>
    <PMID>30447894</PMID>
  </reference>
  <reference>
    <citation>Matsuzaki Y, Matsukawa T, Ohki K, Yamamoto Y, Nakamura M, Oshibuchi T. Warming by resistive heating maintains perioperative normothermia as well as forced air heating. Br J Anaesth. 2003 May;90(5):689-91. doi: 10.1093/bja/aeg106.</citation>
    <PMID>12697600</PMID>
  </reference>
  <reference>
    <citation>Ng V, Lai A, Ho V. Comparison of forced-air warming and electric heating pad for maintenance of body temperature during total knee replacement. Anaesthesia. 2006 Nov;61(11):1100-4. doi: 10.1111/j.1365-2044.2006.04816.x.</citation>
    <PMID>17042850</PMID>
  </reference>
  <reference>
    <citation>John M, Crook D, Dasari K, Eljelani F, El-Haboby A, Harper CM. Comparison of resistive heating and forced-air warming to prevent inadvertent perioperative hypothermia. Br J Anaesth. 2016 Feb;116(2):249-54. doi: 10.1093/bja/aev412.</citation>
    <PMID>26787794</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>October 5, 2021</last_update_submitted>
  <last_update_submitted_qc>October 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</mesh_term>
    <mesh_term>Body Temperature Changes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04410068
org study id: 2019-8860-I
nct id: NCT04410068
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Compare core body temperature after laparoscopic surgery using the forced air heating system
      versus the WARMTAC® (a carbon fiber electric blanket).
In order to prevent perioperative hypothermia, we will compare two different heating sistems,
      one of them is an electric pad made with carbon fiber and the other system is a forced-air
      blanket. Both of them will be situated under the patient during all the laparoscopic surgey.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Core body temperature
time frame: through study completion, an average of 12 months
description: temperatured recorded in esophagus
measure: Rescues number
time frame: through study completion, an average of 12 months
description: Compare number of rescues required by each system to avoid mild hypothermia
measure: skin lesions
time frame: through study completion, an average of 12 months
description: Detect possible skin complications related to heating
arm group label: Electrical heating pad
arm group type: Experimental
description: Electrical heating pad (WARMTAC device). Patients will be randomized to one arm.
In this arm, the WARMTAC device will be conected and warmed to 41 degrees before patients lay down.
arm group label: forced-air warming device
arm group type: Experimental
description: Forced-air warming device (3M device). In this arm, the 3M blanket will be conected to forced-air machine and warmed to 41 degrees before patients lay down.
intervention type: Device
intervention name: WARMTAC
description: Randomization to one of the arms previous to surgery.
arm group label: Electrical heating pad
intervention type: Device
intervention name: 3M Bair Hugger
description: Randomization to one of the arms previous to surgery.
arm group label: forced-air warming device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mireia Chanza, Physician
role: Principal Investigator
affiliation: PSMar
last name: Mirea Chanza
phone: 0034667550215
email: mchanza@parcdesalutmar.cat
facility: 
status: Recruiting
contact: 
country: Spain
citation: Calvo Vecino JM, Casans Frances R, Ripolles Melchor J, Marin Zaldivar C, Gomez Rios MA, Perez Ferrer A, Zaballos Bustingorri JM, Abad Gurumeta A; Grupo de trabajo de la GPC de Hipotermia Perioperatoria No Intencionada de la SEDAR. Clinical practice guideline. Unintentional perioperative hypothermia. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Dec;65(10):564-588. doi: 10.1016/j.redar.2018.07.006. Epub 2018 Nov 15. English, Spanish.
PMID: 30447894
citation: Matsuzaki Y, Matsukawa T, Ohki K, Yamamoto Y, Nakamura M, Oshibuchi T. Warming by resistive heating maintains perioperative normothermia as well as forced air heating. Br J Anaesth. 2003 May;90(5):689-91. doi: 10.1093/bja/aeg106.
PMID: 12697600
citation: Ng V, Lai A, Ho V. Comparison of forced-air warming and electric heating pad for maintenance of body temperature during total knee replacement. Anaesthesia. 2006 Nov;61(11):1100-4. doi: 10.1111/j.1365-2044.2006.04816.x.
PMID: 17042850
citation: John M, Crook D, Dasari K, Eljelani F, El-Haboby A, Harper CM. Comparison of resistive heating and forced-air warming to prevent inadvertent perioperative hypothermia. Br J Anaesth. 2016 Feb;116(2):249-54. doi: 10.1093/bja/aev412.
PMID: 26787794
responsible party type: Sponsor
mesh term: Hypothermia
mesh term: Body Temperature Changes
sharing ipd: No