<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/NCT04457414</url>
  </required_header>
  <id_info>
    <org_study_id>2005-230-113</org_study_id>
    <nct_id>NCT04457414</nct_id>
  </id_info>
  <brief_title>Identifying Cricothyroid Membrane With Ultrasound</brief_title>
  <official_title>Learning Curve of Inexperienced Trainees for Identifying Cricothyroid Membrane With Ultrasound in Pediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cannot-intubate cannot-ventilate situations in healthy children are uncommon but are often&#xD;
      associated with poor outcome. We studied the learning curves of inexperienced trainees for&#xD;
      identifying cricothyroid membrane with ultrasound in pediatric patients. After watching an&#xD;
      instructional video, 30 trainees performed 5 cricothyroid membrane identification on&#xD;
      pediatric patients undergoing general anesthesia. We analysed their learning curves relative&#xD;
      to performance time and ultrasound anatomy of cricothyroid membrane and relative structures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">February 5, 2021</completion_date>
  <primary_completion_date type="Actual">February 5, 2021</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>Performance time for identifying cricothyroid membrane with ultrasound</measure>
    <time_frame>from immediately after anesthetic induction to end of surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ultrasound anatomy of cricothyroid membrane</measure>
    <time_frame>from immediately after anesthetic induction to end of surgery</time_frame>
    <description>depth from skin surface, thickness, diameter, relative vessels</description>
  </secondary_outcome>
  <enrollment type="Actual">150</enrollment>
  <condition>Ultrasound</condition>
  <eligibility>
    <study_pop>
      <textblock>
        pediatric patients undergoing general anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pediatric patients undergoing general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous history of tracheostomy&#xD;
&#xD;
          -  previous history of operation on neck&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul national university hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>February 6, 2021</last_update_submitted>
  <last_update_submitted_qc>February 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Eun-hee Kim</investigator_full_name>
    <investigator_title>Clinical assistant professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT04457414
org study id: 2005-230-113
nct id: NCT04457414
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Cannot-intubate cannot-ventilate situations in healthy children are uncommon but are often
      associated with poor outcome. We studied the learning curves of inexperienced trainees for
      identifying cricothyroid membrane with ultrasound in pediatric patients. After watching an
      instructional video, 30 trainees performed 5 cricothyroid membrane identification on
      pediatric patients undergoing general anesthesia. We analysed their learning curves relative
      to performance time and ultrasound anatomy of cricothyroid membrane and relative structures.
observational model: Cohort
time perspective: Prospective
measure: Performance time for identifying cricothyroid membrane with ultrasound
time frame: from immediately after anesthetic induction to end of surgery
measure: ultrasound anatomy of cricothyroid membrane
time frame: from immediately after anesthetic induction to end of surgery
description: depth from skin surface, thickness, diameter, relative vessels
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Eun-hee Kim
investigator title: Clinical assistant professor