<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/NCT02975830</url>
  </required_header>
  <id_info>
    <org_study_id>H-01-R-012/16-460</org_study_id>
    <nct_id>NCT02975830</nct_id>
  </id_info>
  <brief_title>Tracheobronchial Angle in Children - Three-dimensional Computed Tomography Based Measurements</brief_title>
  <official_title>Tracheobronchial Angle in Children - Three-dimensional Computed Tomography Based Measurements</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Fahad Medical City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Fahad Medical City</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Accurate understanding of tracheobronchial anatomy is important for application of various&#xD;
      airway maneuvers in anesthesiology in children. Majority of pediatric anesthesia textbooks&#xD;
      state that the anatomic orientation of the right main bronchus is at less acute angle to the&#xD;
      vertical tracheal axis, although these angles tend to be similar in children younger than&#xD;
      three years of ageThe visualization of the air column in tracheobronchial tree in a&#xD;
      three-dimensional (3D) CT-based image is clear with the air column simulating the actual&#xD;
      internal shape of the airway.&#xD;
&#xD;
      We hypothesize that RBA and LBA are unequal as children like adults are prone to right&#xD;
      mainstem intubation We have measured the right and left bronchial angle using the three&#xD;
      dimensional CT based images of the air column in the tracheobronchial tree.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Accurate understanding of tracheobronchial anatomy is important for application of various&#xD;
      airway maneuvers in anesthesiology in children.&#xD;
&#xD;
      Significant variations and discrepancies in the reported tracheobronchial angles are found in&#xD;
      literature.&#xD;
&#xD;
      Various imaging modalities ranging from chest x-ray to helical computed tomography (CT) have&#xD;
      been used for measuring the tracheobronchial angles in children and the results are varied&#xD;
      with some studies reporting equal angles [2016] while others reporting right bronchial angle&#xD;
      to be smaller than left bronchial angle [Kubota].&#xD;
&#xD;
      The visualization of the air column in tracheobronchial tree in a three-dimensional (3D)&#xD;
      CT-based image is clear with the air column simulating the actual internal shape of the&#xD;
      airway. The highest quality medical-grade (3D) images are obtained using CT data [Uchida M].&#xD;
      Computed tomography (CT) is considered the current gold standard for airway measurements as&#xD;
      the air-tissue interface is better delineated by CT imaging [Reinhardt].&#xD;
&#xD;
      We hypothesize that RBA and LBA are unequal as children like adults are prone to right&#xD;
      mainstem intubation We have measured the right and left bronchial angle using the three&#xD;
      dimensional CT based images of the air column in the tracheobronchial tree.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>tracheobronchial angles</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">270</enrollment>
  <condition>Bronchus</condition>
  <condition>Pediatric Airway</condition>
  <arm_group>
    <arm_group_label>0-2 years</arm_group_label>
    <description>Children aged from birth to 24 months Three dimensional CT based images</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2-4 Years</arm_group_label>
    <description>Children aged from 25-48 months Three dimensional CT based images</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4-6 Years</arm_group_label>
    <description>Children aged from 49-72 Three dimensional CT based images</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6-8 years</arm_group_label>
    <description>Children aged from 73-96 months Three dimensional CT based images</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Three dimensional CT based images</intervention_name>
    <description>Right bronchial angle, left bronchial angle</description>
    <arm_group_label>0-2 years</arm_group_label>
    <arm_group_label>2-4 Years</arm_group_label>
    <arm_group_label>4-6 Years</arm_group_label>
    <arm_group_label>6-8 years</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        upto 8years of age&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CT scans airways&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any disease that is anticipated to distort the normal shape of airways wee excluded&#xD;
             from the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>January 1, 2017</last_update_submitted>
  <last_update_submitted_qc>January 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Fahad Medical City</investigator_affiliation>
    <investigator_full_name>Tariq Wani</investigator_full_name>
    <investigator_title>Consultant Anesthesiologist</investigator_title>
  </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/NCT02975830
org study id: H-01-R-012/16-460
nct id: NCT02975830
lead sponsor: 
has dmc: No
Accurate understanding of tracheobronchial anatomy is important for application of various
      airway maneuvers in anesthesiology in children. Majority of pediatric anesthesia textbooks
      state that the anatomic orientation of the right main bronchus is at less acute angle to the
      vertical tracheal axis, although these angles tend to be similar in children younger than
      three years of ageThe visualization of the air column in tracheobronchial tree in a
      three-dimensional (3D) CT-based image is clear with the air column simulating the actual
      internal shape of the airway.

      We hypothesize that RBA and LBA are unequal as children like adults are prone to right
      mainstem intubation We have measured the right and left bronchial angle using the three
      dimensional CT based images of the air column in the tracheobronchial tree.
Accurate understanding of tracheobronchial anatomy is important for application of various
      airway maneuvers in anesthesiology in children.

      Significant variations and discrepancies in the reported tracheobronchial angles are found in
      literature.

      Various imaging modalities ranging from chest x-ray to helical computed tomography (CT) have
      been used for measuring the tracheobronchial angles in children and the results are varied
      with some studies reporting equal angles [2016] while others reporting right bronchial angle
      to be smaller than left bronchial angle [Kubota].

      The visualization of the air column in tracheobronchial tree in a three-dimensional (3D)
      CT-based image is clear with the air column simulating the actual internal shape of the
      airway. The highest quality medical-grade (3D) images are obtained using CT data [Uchida M].
      Computed tomography (CT) is considered the current gold standard for airway measurements as
      the air-tissue interface is better delineated by CT imaging [Reinhardt].

      We hypothesize that RBA and LBA are unequal as children like adults are prone to right
      mainstem intubation We have measured the right and left bronchial angle using the three
      dimensional CT based images of the air column in the tracheobronchial tree.
observational model: Case-Only
time perspective: Retrospective
measure: tracheobronchial angles
time frame: 6 months
arm group label: 0-2 years
description: Children aged from birth to 24 months Three dimensional CT based images
arm group label: 2-4 Years
description: Children aged from 25-48 months Three dimensional CT based images
arm group label: 4-6 Years
description: Children aged from 49-72 Three dimensional CT based images
arm group label: 6-8 years
description: Children aged from 73-96 months Three dimensional CT based images
intervention type: Radiation
intervention name: Three dimensional CT based images
description: Right bronchial angle, left bronchial angle
arm group label: 0-2 years
arm group label: 2-4 Years
arm group label: 4-6 Years
arm group label: 6-8 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 8 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: King Fahad Medical City
investigator full name: Tariq Wani
investigator title: Consultant Anesthesiologist
sharing ipd: No