<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/NCT04503031</url>
  </required_header>
  <id_info>
    <org_study_id>2019-11-043-001</org_study_id>
    <nct_id>NCT04503031</nct_id>
  </id_info>
  <brief_title>Comparison of Nasal Taper-guard Cuffed and a Nasal Cylindrical Endotracheal Tube</brief_title>
  <official_title>Comparison of the Endotracheal Tube Cuff Pressure Between a Taper-guard Cuffed Nasal Endotracheal Tube and a Cylindrical-shaped Cuffed Nasal Endotracheal Tube After Changing in Position of Head</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>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>
      This study was designed to evaluate the effect of change of head position on the cuff&#xD;
      pressure of TaperGaurd endotracheal tube , compared to cylindrical endotracheal tube during&#xD;
      oral surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patient in cylindrical group (n=26) were intubated with cylindrical shaped endotracheal&#xD;
      tube (Unomedical, Kedah, Malaysia) and the patient in tapergaurd group (n=26) was intubated&#xD;
      with TaperGuard endotracheal tube (Covidien, Athlone, Ireland). The group allocations were&#xD;
      informed to the attending anesthesiologist prior to anesthesia. Tracheal intubation was&#xD;
      performed with size of inner diameter 7.0 mm endotracheal tube for male and 6.5 mm&#xD;
      endotracheal tube for female by the same anesthesiologist. The anesthesiologist measured cuff&#xD;
      pressure and distance from endotracheal tube tip to carina during study period.This study was&#xD;
      designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd&#xD;
      endotracheal tube, compared to cylindrical endotracheal tube during oral surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2020</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 1, 2020</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cuff pressure</measure>
    <time_frame>5 minutes after change of head position</time_frame>
    <description>Cuff pressure is measured with a manometer (Mallinckrodt Medical, Hennef, Germany).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Endotracheal Tube</condition>
  <condition>Cuff Pressure</condition>
  <arm_group>
    <arm_group_label>cylindrical tube group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patient in cylindrical tube group (n=26) were intubated with cylindrical shaped endotracheal tube.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tapergaurd tube group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient in taperguard tube group (n=26) was intubated with TaperGuard endotracheal tube.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TaperGuard endotracheal tube</intervention_name>
    <description>TaperGuard endotracheal tube is intubated</description>
    <arm_group_label>tapergaurd tube group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>cylindrical endotracheal tube</intervention_name>
    <description>endotracheal tube is intubated</description>
    <arm_group_label>cylindrical tube group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who were underwent nasal intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of difficult intubation, limited neck movement, respiratory diseases and body&#xD;
             mass 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, Mr</last_name>
    <role>Principal Investigator</role>
    <affiliation>kyungook 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>October 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>October 26, 2020</last_update_submitted>
  <last_update_submitted_qc>October 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2020</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>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/NCT04503031
org study id: 2019-11-043-001
nct id: NCT04503031
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study was designed to evaluate the effect of change of head position on the cuff
      pressure of TaperGaurd endotracheal tube , compared to cylindrical endotracheal tube during
      oral surgery.
The patient in cylindrical group (n=26) were intubated with cylindrical shaped endotracheal
      tube (Unomedical, Kedah, Malaysia) and the patient in tapergaurd group (n=26) was intubated
      with TaperGuard endotracheal tube (Covidien, Athlone, Ireland). The group allocations were
      informed to the attending anesthesiologist prior to anesthesia. Tracheal intubation was
      performed with size of inner diameter 7.0 mm endotracheal tube for male and 6.5 mm
      endotracheal tube for female by the same anesthesiologist. The anesthesiologist measured cuff
      pressure and distance from endotracheal tube tip to carina during study period.This study was
      designed to evaluate the effect of change of head position on the cuff pressure of TaperGaurd
      endotracheal tube, compared to cylindrical endotracheal tube during oral surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Cuff pressure
time frame: 5 minutes after change of head position
description: Cuff pressure is measured with a manometer (Mallinckrodt Medical, Hennef, Germany).
arm group label: cylindrical tube group
arm group type: Active Comparator
description: The patient in cylindrical tube group (n=26) were intubated with cylindrical shaped endotracheal tube.
arm group label: tapergaurd tube group
arm group type: Experimental
description: The patient in taperguard tube group (n=26) was intubated with TaperGuard endotracheal tube.
intervention type: Device
intervention name: TaperGuard endotracheal tube
description: TaperGuard endotracheal tube is intubated
arm group label: tapergaurd tube group
intervention type: Device
intervention name: cylindrical endotracheal tube
description: endotracheal tube is intubated
arm group label: cylindrical tube group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Younghoon Jeon, Mr
role: Principal Investigator
affiliation: kyungook 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: No