<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/NCT03040440</url>
  </required_header>
  <id_info>
    <org_study_id>KNUH 2016-03-001-004</org_study_id>
    <nct_id>NCT03040440</nct_id>
  </id_info>
  <brief_title>Comparison of the Cuff Pressure of TaperGuard and Cylindrical- Endotracheal Tube During Laparoscopic Surgery</brief_title>
  <official_title>Comparison of the Cuff Pressure of TaperGuard Endotracheal Tube and Cylindrical- Endotracheal Tube During Laparoscopic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyungpook National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyungpook National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study was to compare the cuff pressure between cylindrical and TaperGuard&#xD;
      endotracheal tube during laparoscopic cholecystectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty four participants were assigned to one of the two groups: cylindrical and TaperGuard&#xD;
      endotracheal tube. At the supine position, cuff pressure of endotracheal tube was measured&#xD;
      before and after abdominal insufflation in the supine position. After insufflation the&#xD;
      head-up position (30°) was made and cuff pressure was recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">December 30, 2016</completion_date>
  <primary_completion_date type="Actual">December 15, 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>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cuff pressure</measure>
    <time_frame>5 minutes after intubation</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Cuff Pressure</condition>
  <arm_group>
    <arm_group_label>Cylindrical endotracheal tube</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cylindrical endotracheal tube was intubated in 32 participants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TaperGuard endotracheal tube</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TaperGuard endotracheal tube was intubated in 32 participants</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cylindrical endotracheal tube</intervention_name>
    <description>Cylindrical endotracheal tube was intubated</description>
    <arm_group_label>Cylindrical endotracheal tube</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TaperGaurd endotracheal tube</intervention_name>
    <description>TaperGaurd endotracheal tube was intubated</description>
    <arm_group_label>TaperGuard endotracheal tube</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who were underwent laparoscopic cholecystectomy with American Society of&#xD;
             Anesthesiologists physical status 1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history with respiratory disease, difficult intubation, and morbid obesity (body mass&#xD;
             index more than 35 kg/m2).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Younghoon Jeon, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Kyungpook National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>700-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyungpook National University Hospital</investigator_affiliation>
    <investigator_full_name>Younghoon Jeon</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03040440
org study id: KNUH 2016-03-001-004
nct id: NCT03040440
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to compare the cuff pressure between cylindrical and TaperGuard
      endotracheal tube during laparoscopic cholecystectomy.
Sixty four participants were assigned to one of the two groups: cylindrical and TaperGuard
      endotracheal tube. At the supine position, cuff pressure of endotracheal tube was measured
      before and after abdominal insufflation in the supine position. After insufflation the
      head-up position (30°) was made and cuff pressure was recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: cuff pressure
time frame: 5 minutes after intubation
arm group label: Cylindrical endotracheal tube
arm group type: Active Comparator
description: Cylindrical endotracheal tube was intubated in 32 participants
arm group label: TaperGuard endotracheal tube
arm group type: Experimental
description: TaperGuard endotracheal tube was intubated in 32 participants
intervention type: Device
intervention name: Cylindrical endotracheal tube
description: Cylindrical endotracheal tube was intubated
arm group label: Cylindrical endotracheal tube
intervention type: Device
intervention name: TaperGaurd endotracheal tube
description: TaperGaurd endotracheal tube was intubated
arm group label: TaperGuard endotracheal tube
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Younghoon Jeon, MD
role: Study Chair
affiliation: Kyungpook National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kyungpook National University Hospital
investigator full name: Younghoon Jeon
investigator title: Professor
sharing ipd: Yes