<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/NCT04409652</url>
  </required_header>
  <id_info>
    <org_study_id>AJIRB-MED-OBS-20-055</org_study_id>
    <nct_id>NCT04409652</nct_id>
  </id_info>
  <brief_title>Head Position on Preventing Emergence Cough</brief_title>
  <official_title>Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ajou University School of Medicine</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>
      The purpose of this study is to investigate the effect of head position on prevent the&#xD;
      emergence cough followed by endotracheal extubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During endotrachl intubaion, the sniffing postion is most commonly recommended. However, the&#xD;
      head position to reduce the emergence cough followed by endotracheal extubation was not&#xD;
      confirmed yet. Considering the endotracheal tube vector, head elevation with pillow is&#xD;
      thought to be acceptable more.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 2, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The severity of cough</measure>
    <time_frame>during extubation</time_frame>
    <description>0: no cough, 1:single 2: more than one episode of non-sustained cough, 3: sustained and repetitive cough</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Gallbladder Diseases</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The endotracheal extubation is performed in head on bed without pillow.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Head elevation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The endotracheal extubation is performed in head elevation on pillow (slight flextion of neck on chest) .</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Head on bed</intervention_name>
    <description>During emergence, head is kept on bed without pillow.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Head on pillow</intervention_name>
    <description>During emergence, head is kept on pillow.</description>
    <arm_group_label>Head elevation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Operation schedule of laparoscopic cholecystectomy&#xD;
&#xD;
          -  Must be performed under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 30 kg/m2&#xD;
&#xD;
          -  Respiratory infection&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine</name>
      <address>
        <city>Suwon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ji Eun Kim</last_name>
      <phone>82-31-219-5575</phone>
      <email>beye98@aumc.ac.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>October 21, 2021</last_update_submitted>
  <last_update_submitted_qc>October 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ajou University School of Medicine</investigator_affiliation>
    <investigator_full_name>Ji Eun Kim</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallbladder Diseases</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/NCT04409652
org study id: AJIRB-MED-OBS-20-055
nct id: NCT04409652
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the effect of head position on prevent the
      emergence cough followed by endotracheal extubation.
During endotrachl intubaion, the sniffing postion is most commonly recommended. However, the
      head position to reduce the emergence cough followed by endotracheal extubation was not
      confirmed yet. Considering the endotracheal tube vector, head elevation with pillow is
      thought to be acceptable more.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: The severity of cough
time frame: during extubation
description: 0: no cough, 1:single 2: more than one episode of non-sustained cough, 3: sustained and repetitive cough
arm group label: Control group
arm group type: Placebo Comparator
description: The endotracheal extubation is performed in head on bed without pillow.
arm group label: Head elevation group
arm group type: Active Comparator
description: The endotracheal extubation is performed in head elevation on pillow (slight flextion of neck on chest) .
intervention type: Procedure
intervention name: Head on bed
description: During emergence, head is kept on bed without pillow.
arm group label: Control group
intervention type: Procedure
intervention name: Head on pillow
description: During emergence, head is kept on pillow.
arm group label: Head elevation group
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ajou University School of Medicine
investigator full name: Ji Eun Kim
investigator title: Associate professor
mesh term: Gallbladder Diseases