<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/NCT03241979</url>
  </required_header>
  <id_info>
    <org_study_id>H1706-204-866</org_study_id>
    <nct_id>NCT03241979</nct_id>
  </id_info>
  <brief_title>THRIVE in Pediatric Laryngeal Microsurgery</brief_title>
  <official_title>The Effects of Transnasal Humidified Rapid Insufflation Ventilator Exchange (THRIVE) on the Oxygenation in Pediatric Patients Under Tubeless Airway Surgery - a Physiologic Study</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>
      Transnasal High-flow rapid-insufflation ventilatory exchange (THRIVE) has been shown to&#xD;
      benefit oxygenation, ventilation and upper airway patency in a range of clinical scenarios,&#xD;
      however its use in spontaneously breathing pediatric patients undergoing tubeless airway&#xD;
      surgery has not been described. This is a physiologic study that evaluates the feasibility of&#xD;
      THRIVE during pediatric airway surgery under self-respiration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2017</start_date>
  <completion_date type="Actual">June 3, 2019</completion_date>
  <primary_completion_date type="Actual">June 3, 2019</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>number of low saturation events</measure>
    <time_frame>Intraoperative</time_frame>
    <description>oxygen saturation decrease lower than 90%</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Laryngoscopy</condition>
  <arm_group>
    <arm_group_label>laryngeal microsurgery</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        pediatric patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pediatric patients undergoing laryngeal microsurgery with spontaneous ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe gastrointestinal reflux disease Neuromuscular disease Central hypoventilation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SNUH</name>
      <address>
        <city>Seoul</city>
        <state>Jongro Gu</state>
        <zip>15710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>April 19, 2021</last_update_submitted>
  <last_update_submitted_qc>April 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 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>Hee-Soo Kim</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03241979
org study id: H1706-204-866
nct id: NCT03241979
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Transnasal High-flow rapid-insufflation ventilatory exchange (THRIVE) has been shown to
      benefit oxygenation, ventilation and upper airway patency in a range of clinical scenarios,
      however its use in spontaneously breathing pediatric patients undergoing tubeless airway
      surgery has not been described. This is a physiologic study that evaluates the feasibility of
      THRIVE during pediatric airway surgery under self-respiration.
observational model: Cohort
time perspective: Prospective
measure: number of low saturation events
time frame: Intraoperative
description: oxygen saturation decrease lower than 90%
arm group label: laryngeal microsurgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Hee-Soo Kim
investigator title: professor
sharing ipd: Undecided