<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/NCT03838653</url>
  </required_header>
  <id_info>
    <org_study_id>201207717</org_study_id>
    <nct_id>NCT03838653</nct_id>
  </id_info>
  <brief_title>Influence of Tracheal-bronchial Anatomy Changes on Multi-detector Computed Tomography Scan of the Chest Upon Placement of Left-Sided Double Lumen Endotracheal Tube</brief_title>
  <official_title>Influence of Tracheal-bronchial Anatomy Changes on Multi-detector Computed Tomography Scan of the Chest Upon Placement of Left-Sided Double Lumen Endotracheal Tube</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Javier H Campos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</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>
      One-lung ventilation (OLV) is used for thoracic surgical procedures to facilitate surgical&#xD;
      exposure. Lung isolation is performed using a double-lumen endotracheal tube (DLT) and&#xD;
      optimal position is achieved with the use of fiberoptic bronchoscopy. The most common&#xD;
      technique used to place a left-sided DLT is the blind method technique, which consists of&#xD;
      direct laryngoscopy and rotation of the DLT into the trachea with the aim to intubate the&#xD;
      entrance of the left main bronchus. The DLT will be rotated counterclockwise blindly after&#xD;
      the tip of the DLT passes the vocal cords under direct laryngoscopy. However, in some&#xD;
      occasions, the tip of the DLT migrates into the right bronchus because the alignment between&#xD;
      the trachea and right bronchus is more vertical. The identification of the misplacement can&#xD;
      be challenging, which could lead to the failure of lung isolation. In order to avoid the&#xD;
      unsuccessful lung isolation, Investigators are interested in identifying the factors that&#xD;
      potentially influence the incorrect tube DLT placement diverting into the opposite bronchus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recently, multi-detector 3-dimensional computed tomography (MDCT) scan of the chest is&#xD;
      becoming a routine study for patients requiring thoracic surgical procedures. On the day of&#xD;
      thoracic surgery, the participant will be intubated with a left-sided DLT and investigators&#xD;
      will confirm the correct insertion of the left-sided DLT at first pass under direct&#xD;
      laryngoscopy. This information will be recorded and saved. After the study is completed,&#xD;
      investigators will review the MDCT of the chest to review any abnormal findings and correlate&#xD;
      it with the success of the insertion of the left-sided DLT into the left bronchus.&#xD;
      Investigators will conduct a pilot study to determine the most influential anatomical change&#xD;
      that leads to the DLT misplacement at the first pass based upon the changes of the&#xD;
      tracheal-bronchial anatomy on MDCT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2012</start_date>
  <completion_date type="Actual">June 19, 2013</completion_date>
  <primary_completion_date type="Actual">June 19, 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure tracheal length (mm) derived from MDCT images</measure>
    <time_frame>Within 1 month</time_frame>
    <description>Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. Tracheal length as seen on MDCT images will be measured (millimeters) and compared between the two groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure LMB diameter (mm) derived from MDCT images</measure>
    <time_frame>Within 1 month</time_frame>
    <description>Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. The LMB as seen on MDCT images will be measured (millimeters) and compared between the two groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure RMB diameter (mm) derived from MDCT images</measure>
    <time_frame>Within 1 month</time_frame>
    <description>Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. The RMB as seen on MDCT images will be measured (millimeters) and compared between the two groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure the tracheal LMB curvature (TLMBC) derived from MDCT images</measure>
    <time_frame>Within 1 month</time_frame>
    <description>Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. The TLMBC as seen on MDCT images will be measured and compared between the two groups. TLMBC is measured at the Trachea LMB branch point. The center lines of the airway segments (trachea and LMB) close to the branch point are displayed. A circumscribed circle goes through three adjacent airway points centered at the branch point is produced and the curvature is calculated by the reciprocal of the circle radius. The curvature of a straight line is zero. A larger curvature indicates a sharper turning angle.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure the tracheal RMB curvature (TRMBC) derived from MDCT images</measure>
    <time_frame>Within 1 month</time_frame>
    <description>Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. The TRMBC as seen on MDCT images will be measured and compared between the two groups. TRMBC is measured at the Trachea LMB branch point. The center lines of the airway segments (trachea and RMB) close to the branch point are displayed. A circumscribed circle goes through three adjacent airway points centered at the branch point is produced and the curvature is calculated by the reciprocal of the circle radius. The curvature of a straight line is zero. A larger curvature indicates a sharper turning angle.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Calculate the TLMBC/TRMBC (TLMB/TRMB) Curvature Ratio</measure>
    <time_frame>Within 1 month</time_frame>
    <description>Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. A ratio of the TLMBC and TRMBC values reported above will be calculated and compared between the two groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of the DLT misplacement (RMB intubation) at the fast pass</measure>
    <time_frame>Within 10 minutes</time_frame>
    <description>The number of times DLT misplacement (RMB intubation) at the first pass will be recorded.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">101</enrollment>
  <condition>Intubation, Intratracheal</condition>
  <condition>Multidetector Computed Tomography</condition>
  <arm_group>
    <arm_group_label>Left main bronchus (LMB) intubation</arm_group_label>
    <description>Thoracic surgery patient is intubated with left side double lumen tube (L-DLT) and a fiberoptic bronchoscope is used to verify optimal positioning. The patient is designated as this group when the endobronchial lumen is observed to be in the left main bronchus (correct placement).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Right main bronchus (RMB) intubation</arm_group_label>
    <description>Thoracic surgery patient is intubated with left side double lumen tube (L-DLT) and a fiberoptic bronchoscope is used to verify optimal positioning. The patient is designated as this group when the endobronchial lumen is observed to be in the right main bronchus (incorrect placement).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patient undergoing scheduled thoracic surgery at University of Iowa Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Adult patient undergoing scheduled thoracic surgery which requires left side double&#xD;
             lumen tube placement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  More than 90 years of age&#xD;
&#xD;
          -  Patients with emergency surgery&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Patients who cannot provide their own consent&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Non-English speaking patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javier H Campos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa Hospitals &amp; Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Javier H Campos</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Double-lumen endotracheal tube</keyword>
  <keyword>Multidetector Computed Tomography</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All of the individual participant data (IPD) collected during the trial, after de-identification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Individual participant data will be available for sharing immediately after publication and ending 5 years following article publication.</ipd_time_frame>
    <ipd_access_criteria>Individual participant data will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal</ipd_access_criteria>
  </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/NCT03838653
org study id: 201207717
nct id: NCT03838653
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
One-lung ventilation (OLV) is used for thoracic surgical procedures to facilitate surgical
      exposure. Lung isolation is performed using a double-lumen endotracheal tube (DLT) and
      optimal position is achieved with the use of fiberoptic bronchoscopy. The most common
      technique used to place a left-sided DLT is the blind method technique, which consists of
      direct laryngoscopy and rotation of the DLT into the trachea with the aim to intubate the
      entrance of the left main bronchus. The DLT will be rotated counterclockwise blindly after
      the tip of the DLT passes the vocal cords under direct laryngoscopy. However, in some
      occasions, the tip of the DLT migrates into the right bronchus because the alignment between
      the trachea and right bronchus is more vertical. The identification of the misplacement can
      be challenging, which could lead to the failure of lung isolation. In order to avoid the
      unsuccessful lung isolation, Investigators are interested in identifying the factors that
      potentially influence the incorrect tube DLT placement diverting into the opposite bronchus.
Recently, multi-detector 3-dimensional computed tomography (MDCT) scan of the chest is
      becoming a routine study for patients requiring thoracic surgical procedures. On the day of
      thoracic surgery, the participant will be intubated with a left-sided DLT and investigators
      will confirm the correct insertion of the left-sided DLT at first pass under direct
      laryngoscopy. This information will be recorded and saved. After the study is completed,
      investigators will review the MDCT of the chest to review any abnormal findings and correlate
      it with the success of the insertion of the left-sided DLT into the left bronchus.
      Investigators will conduct a pilot study to determine the most influential anatomical change
      that leads to the DLT misplacement at the first pass based upon the changes of the
      tracheal-bronchial anatomy on MDCT.
observational model: Cohort
time perspective: Prospective
measure: Measure tracheal length (mm) derived from MDCT images
time frame: Within 1 month
description: Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. Tracheal length as seen on MDCT images will be measured (millimeters) and compared between the two groups.
measure: Measure LMB diameter (mm) derived from MDCT images
time frame: Within 1 month
description: Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. The LMB as seen on MDCT images will be measured (millimeters) and compared between the two groups.
measure: Measure RMB diameter (mm) derived from MDCT images
time frame: Within 1 month
description: Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. The RMB as seen on MDCT images will be measured (millimeters) and compared between the two groups.
measure: Measure the tracheal LMB curvature (TLMBC) derived from MDCT images
time frame: Within 1 month
description: Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. The TLMBC as seen on MDCT images will be measured and compared between the two groups. TLMBC is measured at the Trachea LMB branch point. The center lines of the airway segments (trachea and LMB) close to the branch point are displayed. A circumscribed circle goes through three adjacent airway points centered at the branch point is produced and the curvature is calculated by the reciprocal of the circle radius. The curvature of a straight line is zero. A larger curvature indicates a sharper turning angle.
measure: Measure the tracheal RMB curvature (TRMBC) derived from MDCT images
time frame: Within 1 month
description: Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. The TRMBC as seen on MDCT images will be measured and compared between the two groups. TRMBC is measured at the Trachea LMB branch point. The center lines of the airway segments (trachea and RMB) close to the branch point are displayed. A circumscribed circle goes through three adjacent airway points centered at the branch point is produced and the curvature is calculated by the reciprocal of the circle radius. The curvature of a straight line is zero. A larger curvature indicates a sharper turning angle.
measure: Calculate the TLMBC/TRMBC (TLMB/TRMB) Curvature Ratio
time frame: Within 1 month
description: Participants are divided into two groups based upon the first pass location of the L-DLT; LMB (left main bronchus) intubation group and RMB (right main bronchus) intubation group. A ratio of the TLMBC and TRMBC values reported above will be calculated and compared between the two groups.
measure: Incidence of the DLT misplacement (RMB intubation) at the fast pass
time frame: Within 10 minutes
description: The number of times DLT misplacement (RMB intubation) at the first pass will be recorded.
arm group label: Left main bronchus (LMB) intubation
description: Thoracic surgery patient is intubated with left side double lumen tube (L-DLT) and a fiberoptic bronchoscope is used to verify optimal positioning. The patient is designated as this group when the endobronchial lumen is observed to be in the left main bronchus (correct placement).
arm group label: Right main bronchus (RMB) intubation
description: Thoracic surgery patient is intubated with left side double lumen tube (L-DLT) and a fiberoptic bronchoscope is used to verify optimal positioning. The patient is designated as this group when the endobronchial lumen is observed to be in the right main bronchus (incorrect placement).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Javier H Campos, MD
role: Principal Investigator
affiliation: University of Iowa
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Javier H Campos
investigator title: Clinical Professor
sharing ipd: Yes
ipd description: All of the individual participant data (IPD) collected during the trial, after de-identification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.
ipd info type: Study Protocol
ipd time frame: Individual participant data will be available for sharing immediately after publication and ending 5 years following article publication.
ipd access criteria: Individual participant data will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal