<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/NCT02227134</url>
  </required_header>
  <id_info>
    <org_study_id>IRB14-00572</org_study_id>
    <nct_id>NCT02227134</nct_id>
  </id_info>
  <brief_title>Ultrasound to Predict a Pediatric Difficult Airway and Obstructive Sleep Apnea Syndrome in Children</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vidya Raman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective study to see whether ultrasonography can predict difficult airway&#xD;
      and/or predict obstructive sleep apnea syndrome (OSAS) in children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Unable to perform the ultrasound.&#xD;
  </why_stopped>
  <start_date>February 2015</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hyo-mental distance</measure>
    <time_frame>intraoperative</time_frame>
    <description>The distance from the hyoid bone to the mentum to predict difficult airway.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tongue width</measure>
    <time_frame>intraoperative</time_frame>
    <description>Width of the tongue between the lingual arteries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tonsil Size</measure>
    <time_frame>intraoperative</time_frame>
    <description>Size of tonsil (bilateral)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Difficult Airway</condition>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Difficult Airway</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Children with a history of difficult airway intubation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obstructive Sleep Apnea</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Children with a history of obstructive sleep apnea.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Ultrasound to measure hyo-mental distance, tonsil size and width of the tongue.</description>
    <arm_group_label>Difficult Airway</arm_group_label>
    <arm_group_label>Obstructive Sleep Apnea</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with known or suspected difficult direct laryngoscopy identified by either&#xD;
             ENT or anesthesiologist.&#xD;
&#xD;
          -  Children with difficult tracheal intubation aged 1 month - 18 years old&#xD;
&#xD;
          -  Children with obstructive sleep apnea aged 1 year - 8 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parent/ patient refusal to participate in study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Vidya Raman</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <!-- 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/NCT02227134
org study id: IRB14-00572
nct id: NCT02227134
lead sponsor: 
has dmc: No
This is a prospective study to see whether ultrasonography can predict difficult airway
      and/or predict obstructive sleep apnea syndrome (OSAS) in children.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Hyo-mental distance
time frame: intraoperative
description: The distance from the hyoid bone to the mentum to predict difficult airway.
measure: Tongue width
time frame: intraoperative
description: Width of the tongue between the lingual arteries.
measure: Tonsil Size
time frame: intraoperative
description: Size of tonsil (bilateral)
arm group label: Difficult Airway
arm group type: Other
description: Children with a history of difficult airway intubation.
arm group label: Obstructive Sleep Apnea
arm group type: Other
description: Children with a history of obstructive sleep apnea.
intervention type: Procedure
intervention name: Ultrasound
description: Ultrasound to measure hyo-mental distance, tonsil size and width of the tongue.
arm group label: Difficult Airway
arm group label: Obstructive Sleep Apnea
criteria: 
gender: All
minimum age: 1 Month
maximum age: 18 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Vidya Raman
investigator title: Clinical Assistant Professor
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive