<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/NCT04485923</url>
  </required_header>
  <id_info>
    <org_study_id>SGA_temp_adult</org_study_id>
    <nct_id>NCT04485923</nct_id>
  </id_info>
  <brief_title>Accuracy of Body Temperature Measurements Using the Esophageal Temperature Probe Inserted Through the Gastric Lumen of Supraglottic Airway Device</brief_title>
  <official_title>Accuracy of Body Temperature Measurements Using the Esophageal Temperature Probe Inserted Through the Gastric Lumen of Supraglottic Airway Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sojin Shin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In general, 50-90% of patients undergoing surgery under general anesthesia are known to&#xD;
      develop hypothermia during surgery. Due to hypothermia during surgery, the patient may cause&#xD;
      coagulation disorders, wound infections, increased ventricular tachycardia, prolonged&#xD;
      anesthesia drug effects, and electrification, resulting in delayed recovery after surgery,&#xD;
      extended recovery room exit, and extended hospital stay. Therefore, unless intentional&#xD;
      hypothermia is needed, active body temperature management during surgery is necessary.&#xD;
&#xD;
      Pulmonary artery, distal esophagus, tympanic membrane, nasopharynx, oral cavity, axillary&#xD;
      cavity, rectum, and bladder can be measured. The most accurate method for measuring deep body&#xD;
      temperature in general anesthesia is esophageal body temperature, nasopharyngeal body&#xD;
      temperature, It is known as tympanic body temperature. 3,4 However, the tympanic body&#xD;
      temperature has the disadvantage that it cannot be continuously measured. Considering these&#xD;
      points, esophageal thermometers that can be continuously measured in patients with general&#xD;
      anesthesia and have few side effects are commonly used. The esophageal thermometer is usually&#xD;
      inserted through the oral cavity. When the supraglottic airway device is inserted, the space&#xD;
      in the oral cavity is filled with the supraglottic airway device, making it difficult to&#xD;
      mount the esophageal thermometer. However, most second-generation supraglottic airway devices&#xD;
      have gastric lumens, and gastric lumens are connected to the esophagus, allowing esophageal&#xD;
      thermometers to be mounted through this space. Since the esophageal temperature probe is&#xD;
      inserted in all general anesthesia patients using the supraglottic airway device in this&#xD;
      application, the body temperature measured by the temporal artery at the same time is how&#xD;
      accurate the body temperature measured at this time is as a reference value using the&#xD;
      tympanic membrane. I would like to analyze the transient comparison. We will also analyze&#xD;
      whether the esophageal thermometer mounted through the gastric lumen of the supraglottic&#xD;
      airway device reflects the rapidly decreasing body temperature change when the pneumatic&#xD;
      tourniquet is decompressed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Basic anesthesia management is the same as for patients undergoing general anesthesia using&#xD;
      all supraglottic airway devices.&#xD;
&#xD;
      Fasting from midnight the day before surgery, and when the patient enters the operating room,&#xD;
      a blood pressure monitor, electrocardiogram, pulse saturator is mounted, and baseline blood&#xD;
      pressure, oxygen saturation, and heart rate are recorded. As an anesthesia-inducing facial&#xD;
      mask, it provides 100% of 4-6L/min of oxygen. Propofol is administered at 2 mg/kg, and after&#xD;
      the patient's self-breathing is lost, 5% sevoflurane is supplied for 3 minutes to deepen the&#xD;
      depth of anesthesia. After inserting the appropriate size of supraglottic airway (i-gel)&#xD;
      according to the patient's weight, the esophageal temperature probe is inserted through the&#xD;
      gastric lumen to the end of the supraglottic airway device i-gel. After 10 minutes, when the&#xD;
      body temperature measurement measured in the esophagus stabilizes, the body temperature is&#xD;
      measured at the tympanic membrane and temporal artery at 10-minute intervals. For the&#xD;
      objectivity of body temperature measurement, the same operator performs it, and the left and&#xD;
      right sides of the tympanic membrane can be measured differently, so both sides are measured&#xD;
      and averaged. After Tourniquet deflation, body temperature is measured and recorded every 10&#xD;
      minutes from 10 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2020</start_date>
  <completion_date type="Actual">September 16, 2020</completion_date>
  <primary_completion_date type="Actual">September 15, 2020</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>esophageal temperature</measure>
    <time_frame>10min</time_frame>
    <description>'c</description>
  </primary_outcome>
  <enrollment type="Actual">35</enrollment>
  <condition>Core Temperature</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Among patients undergoing knee surgery using tourniquet for more than 1 hour, patients&#xD;
        undergoing general anesthesia using the Supraglottic airway device&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 19 to 80 Patients with ASA PS 1-3 Among patients undergoing knee surgery using&#xD;
             tourniquet for more than 1 hour, patients undergoing general anesthesia using the&#xD;
             Supraglottic airway device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refuse to participate in the study Patients with esophageal tumors or&#xD;
             varicose veins Patients who are inserted through the esophagus during surgery Patients&#xD;
             with ear inflammation Patients who have been deemed unsuitable for participation by&#xD;
             the medical staff for other reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>wonwook ko, professor</last_name>
    <role>Study Chair</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>asanMC</name>
      <address>
        <city>Seoul</city>
        <state>Song-pa</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>January 5, 2021</last_update_submitted>
  <last_update_submitted_qc>January 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Sojin Shin</investigator_full_name>
    <investigator_title>fellow</investigator_title>
  </responsible_party>
  <keyword>core temperature, tympanic membrane, esophageal temperature, temporal artery temperature</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04485923
org study id: SGA_temp_adult
nct id: NCT04485923
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In general, 50-90% of patients undergoing surgery under general anesthesia are known to
      develop hypothermia during surgery. Due to hypothermia during surgery, the patient may cause
      coagulation disorders, wound infections, increased ventricular tachycardia, prolonged
      anesthesia drug effects, and electrification, resulting in delayed recovery after surgery,
      extended recovery room exit, and extended hospital stay. Therefore, unless intentional
      hypothermia is needed, active body temperature management during surgery is necessary.

      Pulmonary artery, distal esophagus, tympanic membrane, nasopharynx, oral cavity, axillary
      cavity, rectum, and bladder can be measured. The most accurate method for measuring deep body
      temperature in general anesthesia is esophageal body temperature, nasopharyngeal body
      temperature, It is known as tympanic body temperature. 3,4 However, the tympanic body
      temperature has the disadvantage that it cannot be continuously measured. Considering these
      points, esophageal thermometers that can be continuously measured in patients with general
      anesthesia and have few side effects are commonly used. The esophageal thermometer is usually
      inserted through the oral cavity. When the supraglottic airway device is inserted, the space
      in the oral cavity is filled with the supraglottic airway device, making it difficult to
      mount the esophageal thermometer. However, most second-generation supraglottic airway devices
      have gastric lumens, and gastric lumens are connected to the esophagus, allowing esophageal
      thermometers to be mounted through this space. Since the esophageal temperature probe is
      inserted in all general anesthesia patients using the supraglottic airway device in this
      application, the body temperature measured by the temporal artery at the same time is how
      accurate the body temperature measured at this time is as a reference value using the
      tympanic membrane. I would like to analyze the transient comparison. We will also analyze
      whether the esophageal thermometer mounted through the gastric lumen of the supraglottic
      airway device reflects the rapidly decreasing body temperature change when the pneumatic
      tourniquet is decompressed.
Basic anesthesia management is the same as for patients undergoing general anesthesia using
      all supraglottic airway devices.

      Fasting from midnight the day before surgery, and when the patient enters the operating room,
      a blood pressure monitor, electrocardiogram, pulse saturator is mounted, and baseline blood
      pressure, oxygen saturation, and heart rate are recorded. As an anesthesia-inducing facial
      mask, it provides 100% of 4-6L/min of oxygen. Propofol is administered at 2 mg/kg, and after
      the patient's self-breathing is lost, 5% sevoflurane is supplied for 3 minutes to deepen the
      depth of anesthesia. After inserting the appropriate size of supraglottic airway (i-gel)
      according to the patient's weight, the esophageal temperature probe is inserted through the
      gastric lumen to the end of the supraglottic airway device i-gel. After 10 minutes, when the
      body temperature measurement measured in the esophagus stabilizes, the body temperature is
      measured at the tympanic membrane and temporal artery at 10-minute intervals. For the
      objectivity of body temperature measurement, the same operator performs it, and the left and
      right sides of the tympanic membrane can be measured differently, so both sides are measured
      and averaged. After Tourniquet deflation, body temperature is measured and recorded every 10
      minutes from 10 minutes.
observational model: Case-Control
time perspective: Prospective
measure: esophageal temperature
time frame: 10min
description: 'c
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
last name: wonwook ko, professor
role: Study Chair
affiliation: Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Asan Medical Center
investigator full name: Sojin Shin
investigator title: fellow
sharing ipd: Undecided