<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/NCT02201095</url>
  </required_header>
  <id_info>
    <org_study_id>STH18196</org_study_id>
    <nct_id>NCT02201095</nct_id>
  </id_info>
  <brief_title>Active Warming During Elective Caesearean Section</brief_title>
  <official_title>Active Warming for Elective Caesarean Section - a RCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      During anaesthesia for caesarean section it is common to lose heat and become hypothermic,&#xD;
      (&lt;36 degrees C). In order to try and avoid this all women are given warmed intravenous fluid&#xD;
      and insulated from cold surfaces. There are also 2 types of machine available to actively&#xD;
      warm women;&#xD;
&#xD;
        1. Forced Air Warming - that uses a disposable sheet the woman lies upon with lots of air&#xD;
           pockets that have warm air blown into them continuously by a fan.&#xD;
&#xD;
        2. Conduction Warming Mattress - a thin mattress which covers the operating table and the&#xD;
           woman lies on top. The padded mattress has strips of material that heat up when&#xD;
           electricity passes through it, similar to a normal electric blanket.&#xD;
&#xD;
      We plan to carry out a randomised controlled trial to compare these 2 methods with the&#xD;
      current practice of no active warming.&#xD;
&#xD;
      The hypothesis for this study is that active warming women during elective caesarean section&#xD;
      prevents women's temperature from dropping and keeps them more comfortable than if active&#xD;
      warming were not used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When a baby is delivered by a surgical procedure (a caesarean section) the woman will usually&#xD;
      have a &quot;spinal&quot; anaesthetic. With a &quot;spinal&quot;, local anaesthetic is injected into the spinal&#xD;
      fluid to make the woman numb from her chest to her feet, allowing her to be comfortable but&#xD;
      awake during the birth. During this type of anaesthetic it is common to lose heat and become&#xD;
      cold or &quot;hypothermic&quot; measured as less than 36 degrees Celsius. Becoming this cold can be&#xD;
      uncomfortable for the woman but also causes other problems. It can make blood clotting less&#xD;
      effective, alter the way wounds heal afterwards and make the woman more likely to develop&#xD;
      infections or problems related to her heart and lungs.&#xD;
&#xD;
      To help keep their temperature stable, the investigators give all women fluid into the veins&#xD;
      that is already warm and ensure that they are well insulated from any cold surfaces. There&#xD;
      are two machines that the investigators can also use to actively warm patients but these are&#xD;
      not yet used in every case. The first method is called &quot;Forced Air Warming&quot; and uses a&#xD;
      special disposable sheet the woman lies upon with lots of air pockets that have warm air&#xD;
      blown into them continuously by a fan. The woman is surrounded by these pockets of warm air,&#xD;
      which help to warm her and also insulate against heat loss. The second method is called a&#xD;
      &quot;Conduction Warming Mattress&quot; and uses a thin mattress which covers the operating table and&#xD;
      the woman lies on top. The padded mattress has strips of material that heat up when&#xD;
      electricity passes through it, similar to a normal electric blanket.&#xD;
&#xD;
      The investigators have already looked at the records of some women having caesarean sections&#xD;
      in our hospital and found that both forced air warming and conduction mattress warming seem&#xD;
      to help them stay warm. However, the investigators would like to study this in more detail&#xD;
      and prove scientifically whether these methods are effective. Our aim in this study is to see&#xD;
      if warming machines can help prevent women getting too cold, and prove scientifically whether&#xD;
      one is more effective.&#xD;
&#xD;
      The hypothesis for this study is that active warming women during elective caesarean section&#xD;
      prevents women's temperature from dropping and keeps them more comfortable than if active&#xD;
      warming were not used.&#xD;
&#xD;
      The women will have exactly the same anaesthetic as they would have had if they were not in&#xD;
      the study. If a woman agrees to be in the study she will be chosen randomly to receive&#xD;
      either, normal care (including warmed fluids but no warming machines), additional warming&#xD;
      with forced air or additional warming by conduction mattress. Her temperature will be&#xD;
      measured at regular intervals before, during and after the caesarean section, at the same&#xD;
      time she will be asked to score herself on a thermal comfort scale. The results will be&#xD;
      analysed to compare the temperature changes in each group.&#xD;
&#xD;
      The investigators hope that the active warming machines will keep body temperature stable and&#xD;
      prevent hypothermia. If the investigators find out that these machines prevent women getting&#xD;
      cold, they can ensure that the most effective methods of warming during caesarean section&#xD;
      operations are used and minimise problems due to becoming cold.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean temperature on arrival in recovery</measure>
    <time_frame>Temperature will be measured on arrival in recovery.</time_frame>
    <description>The primary outcome of the study is to find whether there is a clinically significant statistical difference between the mean temperatures on arrival in recovery of the control and conduction mattress groups; the control and forced air warming groups; and the conduction mattress and forced air warming groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peri-operative hypothermia</measure>
    <time_frame>Temperature will be measured evry 15 minutes throughout the duration of the procedure and in recovery room. The investigators anticipate that this will be over approximately a 2 hour period.</time_frame>
    <description>To find whether these active warming devices significantly reduce the incidence of peri-operative hypothermia during spinal anaesthesia for caesarean section</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Thermal comfort scores</measure>
    <time_frame>Thermal comfort will be assessed and scored at 15 minute intervals during surgery and in recovery. We anticipate that this will occur over approximately 2 hours.</time_frame>
    <description>To assess whether active warming makes patients too hot and assess maternal thermal comfort and satisfaction during active warming.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Preoperative Hypothermia</condition>
  <arm_group>
    <arm_group_label>Normal care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Normal care - no active warming</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Forced air warming</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Underbody forced air warming blanket</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conduction warming mattress</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Underbody conduction warming mattress</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Forced air warming</intervention_name>
    <arm_group_label>Forced air warming</arm_group_label>
    <other_name>Underbody bairhugger</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conduction warming mattress</intervention_name>
    <arm_group_label>Conduction warming mattress</arm_group_label>
    <other_name>Inditherm conduction mattress</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a singleton, uncomplicated pregnancy, presenting for elective caesarean&#xD;
             section under spinal anaesthesia, where surgery and anaesthesia are expected to be&#xD;
             uncomplicated. Patients scheduled for tubal ligation surgery (sterilisation) as part&#xD;
             of the caesarean section may also be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 18&#xD;
&#xD;
          -  BMI &lt;19 or &gt;30&#xD;
&#xD;
          -  Diseases of pregnancy: e.g. pregnancy induced hypertension&#xD;
&#xD;
          -  Grand Multiparity - ie parity of 5 or greater&#xD;
&#xD;
          -  Pre-operative pyrexia (temperature of 37.5 degrees C or greater)&#xD;
&#xD;
          -  Pre-operative hypothermia (temperature 36.0 degrees or cooler)&#xD;
&#xD;
          -  Significant co-existing maternal disease - e.g. congenital heart disease&#xD;
&#xD;
          -  Co-existing maternal disease that could impact on temperature- e.g. hypo/hyperthyroid&#xD;
&#xD;
          -  Coagulation abnormalities or anticipated excessive blood loss including any form of&#xD;
             abnormal placentation&#xD;
&#xD;
          -  Surgical procedure expected not to be routine/deviation from normal practice&#xD;
&#xD;
          -  Condition preventing full, informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melanie J Woolnough, Mb ChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheffield Teaching Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals NHS Trust</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>October 12, 2016</last_update_submitted>
  <last_update_submitted_qc>October 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>caesarean section</keyword>
  <keyword>perioperative hypothermia</keyword>
  <keyword>active warming</keyword>
  <keyword>forced air warming</keyword>
  <keyword>conduction mattress warming</keyword>
  <keyword>thermal comfort</keyword>
  <keyword>Prevention of</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/NCT02201095
org study id: STH18196
nct id: NCT02201095
lead sponsor: 
has dmc: Yes
During anaesthesia for caesarean section it is common to lose heat and become hypothermic,
      (<36 degrees C). In order to try and avoid this all women are given warmed intravenous fluid
      and insulated from cold surfaces. There are also 2 types of machine available to actively
      warm women;

        1. Forced Air Warming - that uses a disposable sheet the woman lies upon with lots of air
           pockets that have warm air blown into them continuously by a fan.

        2. Conduction Warming Mattress - a thin mattress which covers the operating table and the
           woman lies on top. The padded mattress has strips of material that heat up when
           electricity passes through it, similar to a normal electric blanket.

      We plan to carry out a randomised controlled trial to compare these 2 methods with the
      current practice of no active warming.

      The hypothesis for this study is that active warming women during elective caesarean section
      prevents women's temperature from dropping and keeps them more comfortable than if active
      warming were not used.
When a baby is delivered by a surgical procedure (a caesarean section) the woman will usually
      have a "spinal" anaesthetic. With a "spinal", local anaesthetic is injected into the spinal
      fluid to make the woman numb from her chest to her feet, allowing her to be comfortable but
      awake during the birth. During this type of anaesthetic it is common to lose heat and become
      cold or "hypothermic" measured as less than 36 degrees Celsius. Becoming this cold can be
      uncomfortable for the woman but also causes other problems. It can make blood clotting less
      effective, alter the way wounds heal afterwards and make the woman more likely to develop
      infections or problems related to her heart and lungs.

      To help keep their temperature stable, the investigators give all women fluid into the veins
      that is already warm and ensure that they are well insulated from any cold surfaces. There
      are two machines that the investigators can also use to actively warm patients but these are
      not yet used in every case. The first method is called "Forced Air Warming" and uses a
      special disposable sheet the woman lies upon with lots of air pockets that have warm air
      blown into them continuously by a fan. The woman is surrounded by these pockets of warm air,
      which help to warm her and also insulate against heat loss. The second method is called a
      "Conduction Warming Mattress" and uses a thin mattress which covers the operating table and
      the woman lies on top. The padded mattress has strips of material that heat up when
      electricity passes through it, similar to a normal electric blanket.

      The investigators have already looked at the records of some women having caesarean sections
      in our hospital and found that both forced air warming and conduction mattress warming seem
      to help them stay warm. However, the investigators would like to study this in more detail
      and prove scientifically whether these methods are effective. Our aim in this study is to see
      if warming machines can help prevent women getting too cold, and prove scientifically whether
      one is more effective.

      The hypothesis for this study is that active warming women during elective caesarean section
      prevents women's temperature from dropping and keeps them more comfortable than if active
      warming were not used.

      The women will have exactly the same anaesthetic as they would have had if they were not in
      the study. If a woman agrees to be in the study she will be chosen randomly to receive
      either, normal care (including warmed fluids but no warming machines), additional warming
      with forced air or additional warming by conduction mattress. Her temperature will be
      measured at regular intervals before, during and after the caesarean section, at the same
      time she will be asked to score herself on a thermal comfort scale. The results will be
      analysed to compare the temperature changes in each group.

      The investigators hope that the active warming machines will keep body temperature stable and
      prevent hypothermia. If the investigators find out that these machines prevent women getting
      cold, they can ensure that the most effective methods of warming during caesarean section
      operations are used and minimise problems due to becoming cold.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Mean temperature on arrival in recovery
time frame: Temperature will be measured on arrival in recovery.
description: The primary outcome of the study is to find whether there is a clinically significant statistical difference between the mean temperatures on arrival in recovery of the control and conduction mattress groups; the control and forced air warming groups; and the conduction mattress and forced air warming groups.
measure: Peri-operative hypothermia
time frame: Temperature will be measured evry 15 minutes throughout the duration of the procedure and in recovery room. The investigators anticipate that this will be over approximately a 2 hour period.
description: To find whether these active warming devices significantly reduce the incidence of peri-operative hypothermia during spinal anaesthesia for caesarean section
measure: Thermal comfort scores
time frame: Thermal comfort will be assessed and scored at 15 minute intervals during surgery and in recovery. We anticipate that this will occur over approximately 2 hours.
description: To assess whether active warming makes patients too hot and assess maternal thermal comfort and satisfaction during active warming.
arm group label: Normal care
arm group type: No Intervention
description: Normal care - no active warming
arm group label: Forced air warming
arm group type: Active Comparator
description: Underbody forced air warming blanket
arm group label: Conduction warming mattress
arm group type: Active Comparator
description: Underbody conduction warming mattress
intervention type: Device
intervention name: Forced air warming
arm group label: Forced air warming
other name: Underbody bairhugger
intervention type: Device
intervention name: Conduction warming mattress
arm group label: Conduction warming mattress
other name: Inditherm conduction mattress
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Melanie J Woolnough, Mb ChB
role: Principal Investigator
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Hypothermia