<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/NCT03256786</url>
  </required_header>
  <id_info>
    <org_study_id>kangnamAN</org_study_id>
    <nct_id>NCT03256786</nct_id>
  </id_info>
  <brief_title>Effects of Preanesthetic Forced Air Warming and Administration of Warmed Intravascular Fluid</brief_title>
  <official_title>Effects of Preanesthetic Forced Air Warming and Administration of Warmed Intravascular Fluid on Preventing Hypothermia and Shivering During Cesarean Delivery Under Spinal Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hallym University Kangnam Sacred Heart Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hallym University Kangnam Sacred Heart Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The majority of women (&gt; 60%) developed hypothermia and shivering during cesarean delivery.&#xD;
      Core hypothermia may be associated with a number of adverse outcomes in patients, including&#xD;
      shivering, wound infection, coagulopathy, increased blood loss and transfusion requirements,&#xD;
      decreased metabolism and prolonged recovery. Shivering can result in interference with&#xD;
      monitoring, increased tension on wound edges, and increased oxygen consumption.&#xD;
&#xD;
      A previous study has shown several modalities to prevent hypothermia and shivering in&#xD;
      patients undergoing cesarean delivery with spinal anesthesia. But, single modality&#xD;
      intervention have shown marginal or no efficacy.&#xD;
&#xD;
      Neuraxial anesthesia reduces the threshold for vasoconstriction and shivering. It often also&#xD;
      produces a lower body sympathectomy that provokes a core to peripheral redistribution of body&#xD;
      heat. It is difficult to treat the core to peripheral redistribution of body heat. However&#xD;
      redistribution can be prevented by preanesthetic cutaneous warming. Prewarming hardly changes&#xD;
      core temperature that remains well regulated, but it markedly increases peripheral tissue&#xD;
      heat content. As a result, prewarming reduces the core to peripheral tissue temperature&#xD;
      gradient and the propensity for redistribution after the induction of anesthesia.&#xD;
&#xD;
      We therefore hypothesized that Combined modality active warming consisting of preoperative 15&#xD;
      min of surface warming using a forced air warmer before spinal anesthesia and coloading of&#xD;
      warmed intravenous fluid might reduce perioperative hypothermia and shivering in women&#xD;
      undergoing cesarean delivery. Additionally, We tested the hypothesis that maintaining&#xD;
      maternal normothermia increases newborn temperature and Apgar scores.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2017</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of hypothermia and shivering</measure>
    <time_frame>immediately after arrival at the postanesthesia care unit</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>temperature of newborn</measure>
    <time_frame>immediately after delivery of newborn</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Active warming</arm_group_label>
    <description>preoperative 15 min of surface warming using a forced air warmer before spinal anesthesia and coloading of warmed intravenous fluid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>no preoperative warming and room temperature intravenous fluid</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Prewarming using forced air warmer, warmed intravenous fluid</intervention_name>
    <description>Combined modality active warming consisting of preoperative 15 min of surface warming using a forced air warmer before spinal anesthesia and coloading of warmed intravenous fluid in active warming group</description>
    <arm_group_label>Active warming</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for cesarean delivery under spinal anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for cesarean delivery under spinal anesthesia&#xD;
&#xD;
          -  The American Society of Anesthesiologists physical status class one or two&#xD;
&#xD;
          -  female between 20 and 45&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with heart disease&#xD;
&#xD;
          -  Patients with infectious disease&#xD;
&#xD;
          -  Patients with coagulopathy&#xD;
&#xD;
          -  Patients with a drug allergy&#xD;
&#xD;
          -  In case of switching to general anesthesia&#xD;
&#xD;
          -  Patients BMI under 18.5 or over 31&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eun Mi Choi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hallym University Kangnam Sacred Heart Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kangnam sacred heart hospital</name>
      <address>
        <city>Seoul</city>
        <state>Yeongdeungpo-gu</state>
        <zip>KS013</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Carpenter L, Baysinger CL. Maintaining perioperative normothermia in the patient undergoing cesarean delivery. Obstet Gynecol Surv. 2012 Jul;67(7):436-46. doi: 10.1097/OGX.0b013e3182605ccd.</citation>
    <PMID>22926250</PMID>
  </results_reference>
  <results_reference>
    <citation>Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med. 1996 May 9;334(19):1209-15. doi: 10.1056/NEJM199605093341901.</citation>
    <PMID>8606715</PMID>
  </results_reference>
  <results_reference>
    <citation>Frank SM, Fleisher LA, Breslow MJ, Higgins MS, Olson KF, Kelly S, Beattie C. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial. JAMA. 1997 Apr 9;277(14):1127-34.</citation>
    <PMID>9087467</PMID>
  </results_reference>
  <results_reference>
    <citation>Schmied H, Kurz A, Sessler DI, Kozek S, Reiter A. Mild hypothermia increases blood loss and transfusion requirements during total hip arthroplasty. Lancet. 1996 Feb 3;347(8997):289-92. doi: 10.1016/s0140-6736(96)90466-3.</citation>
    <PMID>8569362</PMID>
  </results_reference>
  <results_reference>
    <citation>Knobel RB, Wimmer JE Jr, Holbert D. Heat loss prevention for preterm infants in the delivery room. J Perinatol. 2005 May;25(5):304-8. doi: 10.1038/sj.jp.7211289.</citation>
    <PMID>15861196</PMID>
  </results_reference>
  <results_reference>
    <citation>Watkinson M. Temperature control of premature infants in the delivery room. Clin Perinatol. 2006 Mar;33(1):43-53, vi. doi: 10.1016/j.clp.2005.11.018.</citation>
    <PMID>16533632</PMID>
  </results_reference>
  <results_reference>
    <citation>Butwick AJ, Lipman SS, Carvalho B. Intraoperative forced air-warming during cesarean delivery under spinal anesthesia does not prevent maternal hypothermia. Anesth Analg. 2007 Nov;105(5):1413-9, table of contents. doi: 10.1213/01.ane.0000286167.96410.27.</citation>
    <PMID>17959975</PMID>
  </results_reference>
  <results_reference>
    <citation>Yokoyama K, Suzuki M, Shimada Y, Matsushima T, Bito H, Sakamoto A. Effect of administration of pre-warmed intravenous fluids on the frequency of hypothermia following spinal anesthesia for Cesarean delivery. J Clin Anesth. 2009 Jun;21(4):242-8. doi: 10.1016/j.jclinane.2008.12.010. Epub 2009 Jun 6.</citation>
    <PMID>19502035</PMID>
  </results_reference>
  <results_reference>
    <citation>Cobb B, Cho Y, Hilton G, Ting V, Carvalho B. Active Warming Utilizing Combined IV Fluid and Forced-Air Warming Decreases Hypothermia and Improves Maternal Comfort During Cesarean Delivery: A Randomized Control Trial. Anesth Analg. 2016 May;122(5):1490-7. doi: 10.1213/ANE.0000000000001181.</citation>
    <PMID>26895002</PMID>
  </results_reference>
  <results_reference>
    <citation>Horn EP, Schroeder F, Gottschalk A, Sessler DI, Hiltmeyer N, Standl T, Schulte am Esch J. Active warming during cesarean delivery. Anesth Analg. 2002 Feb;94(2):409-14, table of contents. doi: 10.1097/00000539-200202000-00034.</citation>
    <PMID>11812709</PMID>
  </results_reference>
  <results_reference>
    <citation>Matsukawa T, Sessler DI, Christensen R, Ozaki M, Schroeder M. Heat flow and distribution during epidural anesthesia. Anesthesiology. 1995 Nov;83(5):961-7. doi: 10.1097/00000542-199511000-00008.</citation>
    <PMID>7486181</PMID>
  </results_reference>
  <results_reference>
    <citation>Matsukawa T, Sessler DI, Sessler AM, Schroeder M, Ozaki M, Kurz A, Cheng C. Heat flow and distribution during induction of general anesthesia. Anesthesiology. 1995 Mar;82(3):662-73. doi: 10.1097/00000542-199503000-00008.</citation>
    <PMID>7879935</PMID>
  </results_reference>
  <results_reference>
    <citation>Rajek A, Greif R, Sessler DI. Effects of epidural anesthesia on thermal sensation. Reg Anesth Pain Med. 2001 Nov-Dec;26(6):527-31. doi: 10.1053/rapm.2001.25924.</citation>
    <PMID>11707791</PMID>
  </results_reference>
  <results_reference>
    <citation>Chung SH, Lee BS, Yang HJ, Kweon KS, Kim HH, Song J, Shin DW. Effect of preoperative warming during cesarean section under spinal anesthesia. Korean J Anesthesiol. 2012 May;62(5):454-60. doi: 10.4097/kjae.2012.62.5.454. Epub 2012 May 24.</citation>
    <PMID>22679543</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hallym University Kangnam Sacred Heart Hospital</investigator_affiliation>
    <investigator_full_name>Choi Eun MI</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>cesarean delivery with spinal anesthesia</keyword>
  <keyword>Hypothermia and shivering</keyword>
  <keyword>Active warming</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</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/NCT03256786
org study id: kangnamAN
nct id: NCT03256786
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The majority of women (> 60%) developed hypothermia and shivering during cesarean delivery.
      Core hypothermia may be associated with a number of adverse outcomes in patients, including
      shivering, wound infection, coagulopathy, increased blood loss and transfusion requirements,
      decreased metabolism and prolonged recovery. Shivering can result in interference with
      monitoring, increased tension on wound edges, and increased oxygen consumption.

      A previous study has shown several modalities to prevent hypothermia and shivering in
      patients undergoing cesarean delivery with spinal anesthesia. But, single modality
      intervention have shown marginal or no efficacy.

      Neuraxial anesthesia reduces the threshold for vasoconstriction and shivering. It often also
      produces a lower body sympathectomy that provokes a core to peripheral redistribution of body
      heat. It is difficult to treat the core to peripheral redistribution of body heat. However
      redistribution can be prevented by preanesthetic cutaneous warming. Prewarming hardly changes
      core temperature that remains well regulated, but it markedly increases peripheral tissue
      heat content. As a result, prewarming reduces the core to peripheral tissue temperature
      gradient and the propensity for redistribution after the induction of anesthesia.

      We therefore hypothesized that Combined modality active warming consisting of preoperative 15
      min of surface warming using a forced air warmer before spinal anesthesia and coloading of
      warmed intravenous fluid might reduce perioperative hypothermia and shivering in women
      undergoing cesarean delivery. Additionally, We tested the hypothesis that maintaining
      maternal normothermia increases newborn temperature and Apgar scores.
observational model: Case-Control
time perspective: Prospective
measure: incidence of hypothermia and shivering
time frame: immediately after arrival at the postanesthesia care unit
measure: temperature of newborn
time frame: immediately after delivery of newborn
arm group label: Active warming
description: preoperative 15 min of surface warming using a forced air warmer before spinal anesthesia and coloading of warmed intravenous fluid
arm group label: Control
description: no preoperative warming and room temperature intravenous fluid
intervention type: Behavioral
intervention name: Prewarming using forced air warmer, warmed intravenous fluid
description: Combined modality active warming consisting of preoperative 15 min of surface warming using a forced air warmer before spinal anesthesia and coloading of warmed intravenous fluid in active warming group
arm group label: Active warming
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eun Mi Choi, MD
role: Study Director
affiliation: Hallym University Kangnam Sacred Heart Hospital
facility: 
country: Korea, Republic of
citation: Carpenter L, Baysinger CL. Maintaining perioperative normothermia in the patient undergoing cesarean delivery. Obstet Gynecol Surv. 2012 Jul;67(7):436-46. doi: 10.1097/OGX.0b013e3182605ccd.
PMID: 22926250
citation: Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med. 1996 May 9;334(19):1209-15. doi: 10.1056/NEJM199605093341901.
PMID: 8606715
citation: Frank SM, Fleisher LA, Breslow MJ, Higgins MS, Olson KF, Kelly S, Beattie C. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial. JAMA. 1997 Apr 9;277(14):1127-34.
PMID: 9087467
citation: Schmied H, Kurz A, Sessler DI, Kozek S, Reiter A. Mild hypothermia increases blood loss and transfusion requirements during total hip arthroplasty. Lancet. 1996 Feb 3;347(8997):289-92. doi: 10.1016/s0140-6736(96)90466-3.
PMID: 8569362
citation: Knobel RB, Wimmer JE Jr, Holbert D. Heat loss prevention for preterm infants in the delivery room. J Perinatol. 2005 May;25(5):304-8. doi: 10.1038/sj.jp.7211289.
PMID: 15861196
citation: Watkinson M. Temperature control of premature infants in the delivery room. Clin Perinatol. 2006 Mar;33(1):43-53, vi. doi: 10.1016/j.clp.2005.11.018.
PMID: 16533632
citation: Butwick AJ, Lipman SS, Carvalho B. Intraoperative forced air-warming during cesarean delivery under spinal anesthesia does not prevent maternal hypothermia. Anesth Analg. 2007 Nov;105(5):1413-9, table of contents. doi: 10.1213/01.ane.0000286167.96410.27.
PMID: 17959975
citation: Yokoyama K, Suzuki M, Shimada Y, Matsushima T, Bito H, Sakamoto A. Effect of administration of pre-warmed intravenous fluids on the frequency of hypothermia following spinal anesthesia for Cesarean delivery. J Clin Anesth. 2009 Jun;21(4):242-8. doi: 10.1016/j.jclinane.2008.12.010. Epub 2009 Jun 6.
PMID: 19502035
citation: Cobb B, Cho Y, Hilton G, Ting V, Carvalho B. Active Warming Utilizing Combined IV Fluid and Forced-Air Warming Decreases Hypothermia and Improves Maternal Comfort During Cesarean Delivery: A Randomized Control Trial. Anesth Analg. 2016 May;122(5):1490-7. doi: 10.1213/ANE.0000000000001181.
PMID: 26895002
citation: Horn EP, Schroeder F, Gottschalk A, Sessler DI, Hiltmeyer N, Standl T, Schulte am Esch J. Active warming during cesarean delivery. Anesth Analg. 2002 Feb;94(2):409-14, table of contents. doi: 10.1097/00000539-200202000-00034.
PMID: 11812709
citation: Matsukawa T, Sessler DI, Christensen R, Ozaki M, Schroeder M. Heat flow and distribution during epidural anesthesia. Anesthesiology. 1995 Nov;83(5):961-7. doi: 10.1097/00000542-199511000-00008.
PMID: 7486181
citation: Matsukawa T, Sessler DI, Sessler AM, Schroeder M, Ozaki M, Kurz A, Cheng C. Heat flow and distribution during induction of general anesthesia. Anesthesiology. 1995 Mar;82(3):662-73. doi: 10.1097/00000542-199503000-00008.
PMID: 7879935
citation: Rajek A, Greif R, Sessler DI. Effects of epidural anesthesia on thermal sensation. Reg Anesth Pain Med. 2001 Nov-Dec;26(6):527-31. doi: 10.1053/rapm.2001.25924.
PMID: 11707791
citation: Chung SH, Lee BS, Yang HJ, Kweon KS, Kim HH, Song J, Shin DW. Effect of preoperative warming during cesarean section under spinal anesthesia. Korean J Anesthesiol. 2012 May;62(5):454-60. doi: 10.4097/kjae.2012.62.5.454. Epub 2012 May 24.
PMID: 22679543
responsible party type: Principal Investigator
investigator affiliation: Hallym University Kangnam Sacred Heart Hospital
investigator full name: Choi Eun MI
investigator title: Clinical Professor
mesh term: Hypothermia
sharing ipd: No