<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/NCT03008473</url>
  </required_header>
  <id_info>
    <org_study_id>20161229</org_study_id>
    <nct_id>NCT03008473</nct_id>
  </id_info>
  <brief_title>Chest CT for the Placement of the Uniblocker</brief_title>
  <official_title>Placement of the Uniblocker Under the Guidence of Chest Computerized Tomography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Hospital of Qinhuangdao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Hospital of Qinhuangdao</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Video laryngoscope and chest CT iminge for the placement of the Uniblocker&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparing the traditional method of Uniblocker intubation and video laryngoscope combined&#xD;
      with chest CT iminge guide the precise localization of Uniblocker&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">September 24, 2017</completion_date>
  <primary_completion_date type="Actual">September 24, 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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intubation Time</measure>
    <time_frame>5min</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Therapeutic Procedural Complication</condition>
  <arm_group>
    <arm_group_label>video laryngoscope and chest CT iminge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First,the operator calculate the distance between the carina and the glottis by CT image and make a marker on the Uniblocker. Then the operator inserted the Uniblocker into the trachea and advanced toward the left main-stem bronchus via the video laryngoscope untill see marker just at the glottis then stopped the insertion .Second, a single lumen tube with appropriate size was intubated via video laryngoscope into the appropriate depth.Third,the Fiberoptic bronchoscopy(FOB) was inserted into single lumen tube to assess the position of the Uniblocker and the injuries of bronchi and carina</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional intubation of Uniblocker</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First, a conventional single lumen tube (SLT) was inserted into trachea at optimal depth via video laryngoscope. Second, a Uniblocker was inserted through SLT and directed to the left main-stem bronchus. Third, an FOB was inserted into the SLT to adjust the Uniblocker to optimal position and assessed the injuries of bronchi and carina.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>video laryngoscope and chest CT iminge</intervention_name>
    <arm_group_label>video laryngoscope and chest CT iminge</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional intubation of uniblocker</intervention_name>
    <arm_group_label>Conventional intubation of Uniblocker</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        BMI less than 35 kg/m2 ASA classifications of I-III, Modified Mallampati classification 1&#xD;
        or 2 Under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age younger than 18 yr or older than 65 yr&#xD;
&#xD;
          -  ASA class IV or V&#xD;
&#xD;
          -  Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ximing Qi, PHD</last_name>
    <role>Study Director</role>
    <affiliation>The First Hospital of Qinhuangdao</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The first hospital of Qinhuangdao</name>
      <address>
        <city>Qinhuangdao</city>
        <state>Hebei</state>
        <zip>066000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>February 22, 2018</last_update_submitted>
  <last_update_submitted_qc>February 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03008473
org study id: 20161229
nct id: NCT03008473
lead sponsor: 
has dmc: Yes
Video laryngoscope and chest CT iminge for the placement of the Uniblocker
Comparing the traditional method of Uniblocker intubation and video laryngoscope combined
      with chest CT iminge guide the precise localization of Uniblocker
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Intubation Time
time frame: 5min
arm group label: video laryngoscope and chest CT iminge
arm group type: Experimental
description: First,the operator calculate the distance between the carina and the glottis by CT image and make a marker on the Uniblocker. Then the operator inserted the Uniblocker into the trachea and advanced toward the left main-stem bronchus via the video laryngoscope untill see marker just at the glottis then stopped the insertion .Second, a single lumen tube with appropriate size was intubated via video laryngoscope into the appropriate depth.Third,the Fiberoptic bronchoscopy(FOB) was inserted into single lumen tube to assess the position of the Uniblocker and the injuries of bronchi and carina
arm group label: Conventional intubation of Uniblocker
arm group type: Experimental
description: First, a conventional single lumen tube (SLT) was inserted into trachea at optimal depth via video laryngoscope. Second, a Uniblocker was inserted through SLT and directed to the left main-stem bronchus. Third, an FOB was inserted into the SLT to adjust the Uniblocker to optimal position and assessed the injuries of bronchi and carina.
intervention type: Device
intervention name: video laryngoscope and chest CT iminge
arm group label: video laryngoscope and chest CT iminge
intervention type: Device
intervention name: Conventional intubation of uniblocker
arm group label: Conventional intubation of Uniblocker
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ximing Qi, PHD
role: Study Director
affiliation: The First Hospital of Qinhuangdao
facility: 
country: China
responsible party type: Sponsor
sharing ipd: Yes