<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/NCT02190032</url>
  </required_header>
  <id_info>
    <org_study_id>2014-06-003-004</org_study_id>
    <nct_id>NCT02190032</nct_id>
  </id_info>
  <brief_title>Modified Angled Tube vs. Conventional Angled Tube in Double-lumen Endotracheal Tube Intubation</brief_title>
  <official_title>Comparison of Individually Modified Angled Tube and Conventional Angled Tube in Double-lumen Endotracheal Tube Intubation: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are trying to compare the individually modified-angled tube and the&#xD;
      conventional-angled tube in ease of double lumen endotracheal tube insertion and the&#xD;
      incidence of related postoperative complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inserting a double lumen endotracheal tube is somewhat more difficult than a single lumen&#xD;
      tube intubation because of its larger outer diameter and the more rigid feature. Moreover,&#xD;
      the airway axes (oral-,pharyngeal-, and laryngotracheal axis) are not always straight under&#xD;
      sniffing condition. Therefore, to make easy to insert a double-lumen tube and reduce the&#xD;
      tube-related complications, we are trying to compare the individually angle-modified tube and&#xD;
      the manufacturer-provided-angled tube.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The time taken to intubate a double-lumen tube</measure>
    <time_frame>within 60 sec</time_frame>
    <description>The time taken to insert the tube begins when the laryngoscope passes the patient's lips and ends when the tube passes the vocal cords</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number of attempts needed for successful intubation</measure>
    <time_frame>Intubation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time taken for the first attempt of intubation</measure>
    <time_frame>within 60 sec</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative sore throat, hoarseness or dysphagia</measure>
    <time_frame>30 minutes and 24hours after extubation</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Hemodynamic change</measure>
    <time_frame>1, 3 and 5 min after intubation</time_frame>
    <description>We will record patient's heart rate, blood pressure and any used cardiovascular drugs at 1, 3 and 5 min after intubation</description>
  </other_outcome>
  <other_outcome>
    <measure>Intubation difficulty scale score</measure>
    <time_frame>At intubation</time_frame>
    <description>Intubation difficulty Scale score is a function of seven parameters : number of attempts, number of operators, number of alternative techniques, cormack grade, lifting force needed, laryngeal pressure and vocal cord mobility.&#xD;
(Ref: Intubation Difficulty Scale, Anesthesiology 1997;87:1290-7)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Intubation, Intratracheal</condition>
  <condition>Thoracic Surgical Procedures</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intubating a manufacturer-provided-angled double-lumen tube (=Conventional-angled group,&quot;MallinckrodtTM endotracheal tube&quot;, Covidien)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tube angle modification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The angle of the double lumen tube(MallinckrodeTM endotracheal tube) is modified individually.At sniffing position, the distal tip of the tube is placed at the patient's cricoid cartilage level and the tube is bent at the intersection point of the two airway axes (oropharyngeal axis and tracheal axis) with an angle between the two axes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mallinckrodt endotracheal tube with a modified angle</intervention_name>
    <description>At sniffing position, the distal tip of a double-lumen tube is located at the patient's cricoid cartilage level and then the tube is bent at the intersection point of oral axis and the pharyngolaryngeal axis with an angle between the two axes.</description>
    <arm_group_label>Tube angle modification</arm_group_label>
    <other_name>Tube angle modification</other_name>
    <other_name>(&quot;MallinckrodeTM endotracheal tube&quot;, Covidien)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mallinckrodt endobronchial tube with a conventional angle</intervention_name>
    <description>Inserting a manufacturer-provided conventional-angled tube</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Mallinckrodt endobronchial tube, Covidien, with conventional-angled tube</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects undergoing thoracic surgery under one lung ventilation&#xD;
&#xD;
          -  Subjects older than 20 yrs who can give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those who need rapid sequence intubation&#xD;
&#xD;
          -  Those with cervical spinal disease (cervical spinal injury, rheumatoid arthritis with&#xD;
             atlantoaxial subluxation)&#xD;
&#xD;
          -  Those with oropharyngeal obstructive disease (including tumor, foreign body)&#xD;
&#xD;
          -  Those who are expected prolonged intubation after surgery&#xD;
&#xD;
          -  Those who are pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jong Hwan Lee, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>July 6, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>February 22, 2015</last_update_submitted>
  <last_update_submitted_qc>February 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Jong Hwan Lee</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT02190032
org study id: 2014-06-003-004
nct id: NCT02190032
lead sponsor: 
has dmc: No
The investigators are trying to compare the individually modified-angled tube and the
      conventional-angled tube in ease of double lumen endotracheal tube insertion and the
      incidence of related postoperative complications.
Inserting a double lumen endotracheal tube is somewhat more difficult than a single lumen
      tube intubation because of its larger outer diameter and the more rigid feature. Moreover,
      the airway axes (oral-,pharyngeal-, and laryngotracheal axis) are not always straight under
      sniffing condition. Therefore, to make easy to insert a double-lumen tube and reduce the
      tube-related complications, we are trying to compare the individually angle-modified tube and
      the manufacturer-provided-angled tube.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: The time taken to intubate a double-lumen tube
time frame: within 60 sec
description: The time taken to insert the tube begins when the laryngoscope passes the patient's lips and ends when the tube passes the vocal cords
measure: The number of attempts needed for successful intubation
time frame: Intubation
measure: The time taken for the first attempt of intubation
time frame: within 60 sec
measure: Postoperative sore throat, hoarseness or dysphagia
time frame: 30 minutes and 24hours after extubation
measure: Hemodynamic change
time frame: 1, 3 and 5 min after intubation
description: We will record patient's heart rate, blood pressure and any used cardiovascular drugs at 1, 3 and 5 min after intubation
measure: Intubation difficulty scale score
time frame: At intubation
description: Intubation difficulty Scale score is a function of seven parameters : number of attempts, number of operators, number of alternative techniques, cormack grade, lifting force needed, laryngeal pressure and vocal cord mobility.
(Ref: Intubation Difficulty Scale, Anesthesiology 1997;87:1290-7)
arm group label: Control group
arm group type: Active Comparator
description: Intubating a manufacturer-provided-angled double-lumen tube (=Conventional-angled group,"MallinckrodtTM endotracheal tube", Covidien)
arm group label: Tube angle modification
arm group type: Experimental
description: The angle of the double lumen tube(MallinckrodeTM endotracheal tube) is modified individually.At sniffing position, the distal tip of the tube is placed at the patient's cricoid cartilage level and the tube is bent at the intersection point of the two airway axes (oropharyngeal axis and tracheal axis) with an angle between the two axes.
intervention type: Device
intervention name: Mallinckrodt endotracheal tube with a modified angle
description: At sniffing position, the distal tip of a double-lumen tube is located at the patient's cricoid cartilage level and then the tube is bent at the intersection point of oral axis and the pharyngolaryngeal axis with an angle between the two axes.
arm group label: Tube angle modification
other name: Tube angle modification
other name: ("MallinckrodeTM endotracheal tube", Covidien)
intervention type: Device
intervention name: Mallinckrodt endobronchial tube with a conventional angle
description: Inserting a manufacturer-provided conventional-angled tube
arm group label: Control group
other name: Mallinckrodt endobronchial tube, Covidien, with conventional-angled tube
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Jong Hwan Lee, MD,PhD
role: Principal Investigator
affiliation: Samsung Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Jong Hwan Lee
investigator title: Assistant Professor