<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/NCT02981537</url>
  </required_header>
  <id_info>
    <org_study_id>JHBahk_blocker</org_study_id>
    <nct_id>NCT02981537</nct_id>
  </id_info>
  <brief_title>Two-staged Approach in Positioning Endobronchial Blockers Without Fiberoptic Guidance</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to find a novel method for placing endobronchial blockers&#xD;
      without fiberoptic guidance to provide one-lung isolation during anesthesia for thoracic&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>location of endobronchial blocker</measure>
    <time_frame>immediately after the insertion of blocker by fiberoptic bronchoscope</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>One-lung Ventilation</condition>
  <arm_group>
    <arm_group_label>two-staged</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>positioning endobronchial blockers to appropriate bronchus with two-staged methods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>single-staged</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>positioning endobronchial blockers with traditional single-staged methods</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>two-staged endobronchial blocker insertion</intervention_name>
    <description>positioning endobronchial blockers in two-staged method</description>
    <arm_group_label>single-staged</arm_group_label>
    <arm_group_label>two-staged</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>single-staged endobronchial blocker insertion</intervention_name>
    <description>positioning endobronchial blockers in traditional single-staged method</description>
    <arm_group_label>single-staged</arm_group_label>
    <arm_group_label>two-staged</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients scheduled for lung resection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refuse to enroll&#xD;
&#xD;
          -  patients with lesions involving mainstem bronchi&#xD;
&#xD;
          -  patients with anomalies in tracheobronchial tree&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JH Bahk</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>July 12, 2017</last_update_submitted>
  <last_update_submitted_qc>July 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jae-Hyon Bahk, MD, PhD</investigator_full_name>
    <investigator_title>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/NCT02981537
org study id: JHBahk_blocker
nct id: NCT02981537
lead sponsor: 
The purpose of this study is to find a novel method for placing endobronchial blockers
      without fiberoptic guidance to provide one-lung isolation during anesthesia for thoracic
      surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: location of endobronchial blocker
time frame: immediately after the insertion of blocker by fiberoptic bronchoscope
arm group label: two-staged
arm group type: Experimental
description: positioning endobronchial blockers to appropriate bronchus with two-staged methods
arm group label: single-staged
arm group type: Active Comparator
description: positioning endobronchial blockers with traditional single-staged methods
intervention type: Device
intervention name: two-staged endobronchial blocker insertion
description: positioning endobronchial blockers in two-staged method
arm group label: single-staged
arm group label: two-staged
intervention type: Device
intervention name: single-staged endobronchial blocker insertion
description: positioning endobronchial blockers in traditional single-staged method
arm group label: single-staged
arm group label: two-staged
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: JH Bahk
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jae-Hyon Bahk, MD, PhD
investigator title: Professor