<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/NCT03030781</url>
  </required_header>
  <id_info>
    <org_study_id>H-01-R-012, 17-010</org_study_id>
    <nct_id>NCT03030781</nct_id>
  </id_info>
  <brief_title>Relationship of Cricoid With the Right and Left Bronchial Diameters in the Pediatric Population Using Three-dimensional Imaging.</brief_title>
  <official_title>Relationship of Cricoid With the Right and Left Bronchial Diameters in the Pediatric Population Using Three-dimensional Imaging.</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>
      Specific and objective guidelines for choosing endobronchial tube size for main-stem&#xD;
      intubation in pediatric patients are lacking. The objective criteria for choosing an ETT size&#xD;
      for OLV are likely to increase the safety and success. The primary aims of this study were to&#xD;
      define the relationship between cricoid and mainstem bronchi (right and left) in children of&#xD;
      various ages and to determine the effects of age, height and weight.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Understanding the relationship between cricoid and mainstem bronchi can provide to be a&#xD;
      useful adjunct for lung isolation in children. The relationship between cricoid dimensions&#xD;
      and the dimensions of main-stem bronchi (right and left) have been studied using 2&#xD;
      dimensional CT images and video-bronchoscopic images. The present study defines the&#xD;
      volume-based relationship between the right main-stem bronchus (RMSB), left main-stem&#xD;
      bronchus (LMSB) and the cricoid ring based on 3 dimensional CT derived images.&#xD;
&#xD;
      Methods: The three dimensional CT images of 35 children, younger than 8 years, undergoing&#xD;
      radiological evaluation unrelated to airway symptomatology were examined. The children were&#xD;
      evaluated during spontaneous ventilation without airway devices either during natural sleep&#xD;
      or with sedation. The 3-dimensional images of the airway column were evaluated at the level&#xD;
      of cricoid, right mainstem bronchus and left main-stem bronchus, volumes were calculated and&#xD;
      comparisons made between these levels. Univariate and multivariate regression analysis was&#xD;
      used to determine whether one or more of the variables (age, gender, height, weight and&#xD;
      cricoid) had a predictable relationship to the RMSB and the LMSB diameter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>comparison between cricoid and mainstem borncchi</measure>
    <time_frame>1 month to 8 years</time_frame>
  </primary_outcome>
  <enrollment type="Actual">35</enrollment>
  <condition>Larynx</condition>
  <condition>Oxygen</condition>
  <condition>Intubation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The present study evaluated CT images of the chest of children less than 8 years of age.&#xD;
        The database search of the electronic medical records identified 110 patients of which 40&#xD;
        patients qualified for the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children 1 month to 8 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with tracheostomy Tracheoesophageal fistula Presence of mediastinal mass&#xD;
             Diaphragmatic hernia Preterm infants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>96 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>January 21, 2017</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 21, 2017</last_update_submitted>
  <last_update_submitted_qc>January 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 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/NCT03030781
org study id: H-01-R-012, 17-010
nct id: NCT03030781
lead sponsor: 
has dmc: No
Specific and objective guidelines for choosing endobronchial tube size for main-stem
      intubation in pediatric patients are lacking. The objective criteria for choosing an ETT size
      for OLV are likely to increase the safety and success. The primary aims of this study were to
      define the relationship between cricoid and mainstem bronchi (right and left) in children of
      various ages and to determine the effects of age, height and weight.
Understanding the relationship between cricoid and mainstem bronchi can provide to be a
      useful adjunct for lung isolation in children. The relationship between cricoid dimensions
      and the dimensions of main-stem bronchi (right and left) have been studied using 2
      dimensional CT images and video-bronchoscopic images. The present study defines the
      volume-based relationship between the right main-stem bronchus (RMSB), left main-stem
      bronchus (LMSB) and the cricoid ring based on 3 dimensional CT derived images.

      Methods: The three dimensional CT images of 35 children, younger than 8 years, undergoing
      radiological evaluation unrelated to airway symptomatology were examined. The children were
      evaluated during spontaneous ventilation without airway devices either during natural sleep
      or with sedation. The 3-dimensional images of the airway column were evaluated at the level
      of cricoid, right mainstem bronchus and left main-stem bronchus, volumes were calculated and
      comparisons made between these levels. Univariate and multivariate regression analysis was
      used to determine whether one or more of the variables (age, gender, height, weight and
      cricoid) had a predictable relationship to the RMSB and the LMSB diameter.
observational model: Cohort
time perspective: Retrospective
measure: comparison between cricoid and mainstem borncchi
time frame: 1 month to 8 years
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 96 Months
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: King Fahad Medical City
investigator full name: Tariq Wani
investigator title: CONSULTANT ANESTHESIOLOGIST
sharing ipd: No