<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/NCT02243462</url>
  </required_header>
  <id_info>
    <org_study_id>TIH-Anesth-001</org_study_id>
    <secondary_id>IRD_IRB_2014_06_003</secondary_id>
    <nct_id>NCT02243462</nct_id>
  </id_info>
  <brief_title>Preoperative Warming and Perioperative Shivering</brief_title>
  <acronym>PWPS</acronym>
  <official_title>Effectiveness of Pre-operative Warming in Prevention of Peri-operative Shivering</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indus Hospital and Health Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indus Hospital and Health Network</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Shivering is one of the most commonly recognized problem associated with anesthesia, It is&#xD;
      believed to be thermoregulatory in origin. Studies suggest that pre-warming the patient prior&#xD;
      to the surgery can reduce the chances of hypothermia induced shivering during the post&#xD;
      operative period.&#xD;
&#xD;
      Forced air warmers are the most frequently used active warming devices in the peri-operative&#xD;
      setting. Currently, our hospital does not pre-warm patients but if our study shows that&#xD;
      pre-warming reduces post-operative shivering, we will be able to make an evidence based&#xD;
      decision to start this practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inadvertent peri-operative hypothermia (IPH) and shivering is one of the most commonly&#xD;
      recognized problem during anesthesia which is believed to be thermoregulatory in origin.&#xD;
      Although shivering is uncomfortable for most patients, it is unlikely that this relatively&#xD;
      small increase in total body oxygen consumption in the average shivering patient is&#xD;
      associated with increased peri-operative morbidity. It is common for patients to complain&#xD;
      that their worst memory from the recovery room is the intense cold sensation and&#xD;
      uncontrollable shivering. New guidelines recommend that patients core temperature has to be&#xD;
      maintained at &gt;36°C, postoperatively. Studies suggest that pre-warming the patient prior to&#xD;
      the surgery can reduce the chances of hypothermia induced shivering during the post operative&#xD;
      period.&#xD;
&#xD;
      Forced air warmers are the most frequently used active warming devices in the peri-operative&#xD;
      setting. They are effective at preventing hypothermia induced shivering when used before&#xD;
      induction of anesthesia, during anesthesia and surgery, and after emergence in the&#xD;
      post-anesthesia care unit. Other methods such as warm fluids, opioids, blankets and warm&#xD;
      light devices can be used but are less effective as compared to the forced air warming&#xD;
      devices.&#xD;
&#xD;
      Currently, our hospital does not pre-warm patients but if our study shows that pre-warming&#xD;
      reduces post-operative shivering, we will be able to make an evidence based decision to start&#xD;
      this practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>inadvertent shivering post surgery</measure>
    <time_frame>upto 2-3 hours post-surgery</time_frame>
    <description>number of patients who experience shivering in holding bay</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Forced Air Warming Effect on Hypothermia</condition>
  <arm_group>
    <arm_group_label>No pre-op warming</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>No pre-warming in bay before surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pre-op forced air warming</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A forced air warmer device (WarmTouch Convective Warming System) will be used to pre-warm patients in holding bay before surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Forced Air Warmer</intervention_name>
    <description>A forced air warmer device will be used to pre-warm patients for 10 minutes in holding bay before surgery. Air warming device is an electrically powered control unit, hose, and inflatable &quot;blanket&quot;. The control unit has an air filter and heater, which warms air entrained from the environment. The hose connects to a blanket.</description>
    <arm_group_label>Pre-op forced air warming</arm_group_label>
    <other_name>WarmTouch Convective Warming System</other_name>
    <other_name>Forced air warmer (FAW)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No pre-op warming</intervention_name>
    <description>No forced air warming of the patient prior to being taken in for surgery</description>
    <arm_group_label>No pre-op warming</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients going under therapeutic laparoscopic surgery&#xD;
&#xD;
          -  All patients between 15-70 years irrespective of their gender&#xD;
&#xD;
          -  ASA 1-3 patients&#xD;
&#xD;
          -  Those who have given informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient undergoing diagnostic laparoscopic surgery&#xD;
&#xD;
          -  Patients below age of 15 yrs&#xD;
&#xD;
          -  ASA 4 or higher patients&#xD;
&#xD;
          -  Patients not giving informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ali Asghar, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Indus Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shahid Amin</last_name>
    <role>Study Director</role>
    <affiliation>The Indus Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Asghar Ali, MBBS</last_name>
    <email>aliasgherkika@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Naila Baig-Ansari, PhD</last_name>
    <email>naila.baig.ansari@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Indus Hospital</name>
      <address>
        <city>Karachi</city>
        <state>Sind</state>
        <country>Pakistan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Naila Baig-Ansari, PhD</last_name>
      <email>naila.baig.ansari@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Rashna Dubash</last_name>
      <email>rashna.dubash@irdresearch.org</email>
    </contact_backup>
    <investigator>
      <last_name>Ali Asghar, MBBS</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Shahid Amin, MBBS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 14, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>April 14, 2015</last_update_submitted>
  <last_update_submitted_qc>April 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indus Hospital and Health Network</investigator_affiliation>
    <investigator_full_name>Ali Asgher</investigator_full_name>
    <investigator_title>Resident, Anesthesia</investigator_title>
  </responsible_party>
  <keyword>Shivering</keyword>
  <keyword>Hypothermia</keyword>
  <keyword>Postoperative</keyword>
  <keyword>Temperature</keyword>
  <keyword>Forced air warmer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</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/NCT02243462
org study id: TIH-Anesth-001
secondary id: IRD_IRB_2014_06_003
nct id: NCT02243462
lead sponsor: 
has dmc: No
Shivering is one of the most commonly recognized problem associated with anesthesia, It is
      believed to be thermoregulatory in origin. Studies suggest that pre-warming the patient prior
      to the surgery can reduce the chances of hypothermia induced shivering during the post
      operative period.

      Forced air warmers are the most frequently used active warming devices in the peri-operative
      setting. Currently, our hospital does not pre-warm patients but if our study shows that
      pre-warming reduces post-operative shivering, we will be able to make an evidence based
      decision to start this practice.
Inadvertent peri-operative hypothermia (IPH) and shivering is one of the most commonly
      recognized problem during anesthesia which is believed to be thermoregulatory in origin.
      Although shivering is uncomfortable for most patients, it is unlikely that this relatively
      small increase in total body oxygen consumption in the average shivering patient is
      associated with increased peri-operative morbidity. It is common for patients to complain
      that their worst memory from the recovery room is the intense cold sensation and
      uncontrollable shivering. New guidelines recommend that patients core temperature has to be
      maintained at >36°C, postoperatively. Studies suggest that pre-warming the patient prior to
      the surgery can reduce the chances of hypothermia induced shivering during the post operative
      period.

      Forced air warmers are the most frequently used active warming devices in the peri-operative
      setting. They are effective at preventing hypothermia induced shivering when used before
      induction of anesthesia, during anesthesia and surgery, and after emergence in the
      post-anesthesia care unit. Other methods such as warm fluids, opioids, blankets and warm
      light devices can be used but are less effective as compared to the forced air warming
      devices.

      Currently, our hospital does not pre-warm patients but if our study shows that pre-warming
      reduces post-operative shivering, we will be able to make an evidence based decision to start
      this practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: inadvertent shivering post surgery
time frame: upto 2-3 hours post-surgery
description: number of patients who experience shivering in holding bay
arm group label: No pre-op warming
arm group type: Other
description: No pre-warming in bay before surgery.
arm group label: Pre-op forced air warming
arm group type: Active Comparator
description: A forced air warmer device (WarmTouch Convective Warming System) will be used to pre-warm patients in holding bay before surgery
intervention type: Device
intervention name: Forced Air Warmer
description: A forced air warmer device will be used to pre-warm patients for 10 minutes in holding bay before surgery. Air warming device is an electrically powered control unit, hose, and inflatable "blanket". The control unit has an air filter and heater, which warms air entrained from the environment. The hose connects to a blanket.
arm group label: Pre-op forced air warming
other name: WarmTouch Convective Warming System
other name: Forced air warmer (FAW)
intervention type: Other
intervention name: No pre-op warming
description: No forced air warming of the patient prior to being taken in for surgery
arm group label: No pre-op warming
criteria: 
gender: All
minimum age: 15 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ali Asghar, MBBS
role: Principal Investigator
affiliation: The Indus Hospital
last name: Shahid Amin
role: Study Director
affiliation: The Indus Hospital
last name: Asghar Ali, MBBS
email: aliasgherkika@gmail.com
last name: Naila Baig-Ansari, PhD
email: naila.baig.ansari@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Indus Hospital and Health Network
investigator full name: Ali Asgher
investigator title: Resident, Anesthesia
mesh term: Hypothermia