<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/NCT03782090</url>
  </required_header>
  <id_info>
    <org_study_id>4-2018-0698</org_study_id>
    <nct_id>NCT03782090</nct_id>
  </id_info>
  <brief_title>Comparisons of Novel Double-lumen Endobronchial Tube for Blind Lung Isolation Technique With Conventional Double-lumen Endobronchial Tube in Patients Undergoing One-lung Ventilation</brief_title>
  <official_title>Comparisons of Novel Double-lumen Endobronchial Tube for Blind Lung Isolation Technique With Conventional Double-lumen Endobronchial Tube in Patients Undergoing One-lung Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</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 study is prospectively conducted on 190 patients aged between 20 and 85 years, American&#xD;
      Society of Anesthesiologists (ASA) physical status I - III, undergoing one-lung ventilation&#xD;
      for thoracic surgery. Patients were randomly allocated into either control group (n = 95) or&#xD;
      experimental group (n = 95) by a computerized randomization table. The size of endobronchial&#xD;
      tube is decided based on the diameter of left main bronchus measured on the CT finding of&#xD;
      patients. After induction of general anesthesia, in patients assigned to control group,&#xD;
      endobronchial intubation is performed using conventional technique with left-sided&#xD;
      double-lumen endobronchial tube (Shiley®, Covidien, Mansfield, MA, USA). In experimental&#xD;
      group, patients are intubated with novel double-lumen endobronchial tube (Ankor®,Insung&#xD;
      Medical, Wonjou, S. Korea). During intubation, the carina cuff of Ankor® is inflated after&#xD;
      the tube is rotated 90º toward the left. The tube is advanced until slight resistance is&#xD;
      felt, then the carina cuff is deflated. In both groups, fiberoptic bronchoscope is performed&#xD;
      to evaluate the position of endobronchial tube after intubation. If endobronchial tube is not&#xD;
      in optimal position, the depth of tube is corrected to optimal position under guidance of&#xD;
      fiberoptic bronchoscope. Airway injury is confirmed using fiberoptic bronchoscope before&#xD;
      extubation. The success of endobronchial intubation, position of endobronchial tube, the&#xD;
      corrected depth of endobronchial tube, time consumption for endobronchial intubation and&#xD;
      complication of intubation such as airway injury, pain, and hoarseness are compared between&#xD;
      two groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2018</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</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>
    <intervention_model_description>Patients were randomly allocated into either control group (n = 95) or experimental group (n = 95) by a computerized randomization table. In control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endotracheal tube (Shiley®, Covidien, Mansfield, MA, USA). In experimental group, patients are intubated with novel double-lumen endotracheal tube (Ankor®,Insung Medical, Wonjou, S. Korea).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patients, investigators who evaluate complication of intubation are blinded to the study group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Optimal position of double-lumen endobronchial tube</measure>
    <time_frame>1 day (after intubation)</time_frame>
    <description>On fiberoptic bronchoscopic view after intubation, optimal position of double-lumen endobronchial tube is defined when the bronchial cuff of the tube is immediately below the tracheal carina and there is a clear view of the left subcarina with unobstructed left upper and lower bronchi.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The corrected depth of endobronchial tube</measure>
    <time_frame>1 day (after intubation)</time_frame>
    <description>The corrected depth of endobronchial tube is defined as the difference between the depth of endobronchial tube before and after the depth of tube is corrected to optimal position under guidance of fiberoptic.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">190</enrollment>
  <condition>Intubation Tube(Intubation Using Double Lumen Endobronchial Tube)</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endobronchial intubation using conventional technique with left-sided double-lumen endotracheal tube (Shiley®, Covidien, Mansfield, MA, USA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endobronchial intubation using novel left-sided double-lumen endobronchial tube (Ankor®,Insung Medical, Wonjou, S. Korea)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endobronchial intubation</intervention_name>
    <description>In control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endobronchial tube(Shiley®). The tube is introduced into the glottis via direct laryngoscopy. After the tube tip passes the vocal cord, the tube is rotated 90º toward the left. The tube is advanced according to the depth(cm) of the tube calculated by the height of patient(12.5+0.1*height). Afterwards, the depth of the tube is adjusted by the compliance of both lung.&#xD;
In experimental group, patients are intubated with novel double-lumen endobronchial tube(Ankor®). The tube is introduced into the glottis via direct laryngoscopy. After the tube tip passes the vocal cord, the tube is rotated 90º toward the left. Once the carinal cuff of the tube is passed through the vocal cord of patients, the carinal cuff is inflated with 5-8ml of air. The tube is advanced until the tube stops itself at some point along the tracheobronchial tree. And then the carinal cuff is deflated.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ASA classification 1-3&#xD;
&#xD;
          2. aged between 20 to 85&#xD;
&#xD;
          3. undergoing one lung ventilation using left-sided double-lumen endobronchial tube for&#xD;
             thoracic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Expected difficult intubation (neck extension&lt;35 degrees, mandibular-hyoid distance &lt;&#xD;
             6 cm, sternomental distance &lt; 12.5 cm)&#xD;
&#xD;
          2. anomaly of tracheobronchial tree&#xD;
&#xD;
          3. intraluminal lesion in left or right bronchus&#xD;
&#xD;
          4. Obesity (Body Mass Index &gt; 30)&#xD;
&#xD;
          5. upper respiratory infection&#xD;
&#xD;
          6. Thoracic surgical history&#xD;
&#xD;
          7. blood coagulation disorder&#xD;
&#xD;
          8. emergency operation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine, Severance</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>May 16, 2019</last_update_submitted>
  <last_update_submitted_qc>May 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03782090
org study id: 4-2018-0698
nct id: NCT03782090
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study is prospectively conducted on 190 patients aged between 20 and 85 years, American
      Society of Anesthesiologists (ASA) physical status I - III, undergoing one-lung ventilation
      for thoracic surgery. Patients were randomly allocated into either control group (n = 95) or
      experimental group (n = 95) by a computerized randomization table. The size of endobronchial
      tube is decided based on the diameter of left main bronchus measured on the CT finding of
      patients. After induction of general anesthesia, in patients assigned to control group,
      endobronchial intubation is performed using conventional technique with left-sided
      double-lumen endobronchial tube (Shiley®, Covidien, Mansfield, MA, USA). In experimental
      group, patients are intubated with novel double-lumen endobronchial tube (Ankor®,Insung
      Medical, Wonjou, S. Korea). During intubation, the carina cuff of Ankor® is inflated after
      the tube is rotated 90º toward the left. The tube is advanced until slight resistance is
      felt, then the carina cuff is deflated. In both groups, fiberoptic bronchoscope is performed
      to evaluate the position of endobronchial tube after intubation. If endobronchial tube is not
      in optimal position, the depth of tube is corrected to optimal position under guidance of
      fiberoptic bronchoscope. Airway injury is confirmed using fiberoptic bronchoscope before
      extubation. The success of endobronchial intubation, position of endobronchial tube, the
      corrected depth of endobronchial tube, time consumption for endobronchial intubation and
      complication of intubation such as airway injury, pain, and hoarseness are compared between
      two groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients were randomly allocated into either control group (n = 95) or experimental group (n = 95) by a computerized randomization table. In control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endotracheal tube (Shiley®, Covidien, Mansfield, MA, USA). In experimental group, patients are intubated with novel double-lumen endotracheal tube (Ankor®,Insung Medical, Wonjou, S. Korea).
primary purpose: Other
masking: Single (Participant)
masking description: Patients, investigators who evaluate complication of intubation are blinded to the study group.
measure: Optimal position of double-lumen endobronchial tube
time frame: 1 day (after intubation)
description: On fiberoptic bronchoscopic view after intubation, optimal position of double-lumen endobronchial tube is defined when the bronchial cuff of the tube is immediately below the tracheal carina and there is a clear view of the left subcarina with unobstructed left upper and lower bronchi.
measure: The corrected depth of endobronchial tube
time frame: 1 day (after intubation)
description: The corrected depth of endobronchial tube is defined as the difference between the depth of endobronchial tube before and after the depth of tube is corrected to optimal position under guidance of fiberoptic.
arm group label: Control
arm group type: Active Comparator
description: Endobronchial intubation using conventional technique with left-sided double-lumen endotracheal tube (Shiley®, Covidien, Mansfield, MA, USA)
arm group label: Experimental
arm group type: Experimental
description: Endobronchial intubation using novel left-sided double-lumen endobronchial tube (Ankor®,Insung Medical, Wonjou, S. Korea)
intervention type: Device
intervention name: Endobronchial intubation
description: In control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endobronchial tube(Shiley®). The tube is introduced into the glottis via direct laryngoscopy. After the tube tip passes the vocal cord, the tube is rotated 90º toward the left. The tube is advanced according to the depth(cm) of the tube calculated by the height of patient(12.5+0.1*height). Afterwards, the depth of the tube is adjusted by the compliance of both lung.
In experimental group, patients are intubated with novel double-lumen endobronchial tube(Ankor®). The tube is introduced into the glottis via direct laryngoscopy. After the tube tip passes the vocal cord, the tube is rotated 90º toward the left. Once the carinal cuff of the tube is passed through the vocal cord of patients, the carinal cuff is inflated with 5-8ml of air. The tube is advanced until the tube stops itself at some point along the tracheobronchial tree. And then the carinal cuff is deflated.
arm group label: Control
arm group label: Experimental
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
sharing ipd: No