<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/NCT03817177</url>
  </required_header>
  <id_info>
    <org_study_id>1812-111-998</org_study_id>
    <nct_id>NCT03817177</nct_id>
  </id_info>
  <brief_title>Application of High Flow Nasal Cannula for Prevention of Post-extubation Atelectasis in Children Undergoing Surgery</brief_title>
  <official_title>Seoul National University Hospital Department of Anesthesiology and Pain Medicine</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>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      postoperative atelectasis observation by ultrasound after application of high flow nasal&#xD;
      cannula oxygenation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After surgery, postoperative atelectasis observation by ultrasound grading comparison between&#xD;
      application of conventional nasal prong and high flow nasal cannula device&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 2, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>lung sound score</measure>
    <time_frame>30 minutes after arrival of postanesthetic care unit</time_frame>
    <description>0: Normal aeration (N): presence of lung sliding with A lines or fewer than two isolated B lines&#xD;
Moderate loss of lung aeration: multiple well-defined B lines (B1 lines)&#xD;
Severe loss of lung aeration: multiple coalescent B lines (B2 lines)&#xD;
Lung consolidation (C): the presence of a tissue pattern characterized by dynamic air</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Atelectasis</condition>
  <arm_group>
    <arm_group_label>nasal prong</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>conventional nasal prong application after the surgery in postanesthetic care unit (PACU)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high flow nasal cannula oxygenation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>high flow nasal cannula application after the surgery in postanesthetic care unit (PACU)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>high flow nasal cannula oxygenation</intervention_name>
    <description>high flow nasal cannula application in PACU</description>
    <arm_group_label>high flow nasal cannula oxygenation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>nasal prong</intervention_name>
    <description>conventional nasal prong application in PACU</description>
    <arm_group_label>nasal prong</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  preterm&#xD;
&#xD;
          -  bronchopulmonary dysplasia&#xD;
&#xD;
          -  upper respiratory infection history&#xD;
&#xD;
          -  respiratory disease&#xD;
&#xD;
          -  cardiac surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hee-Soo Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hee-Soo Kim, MD, Phd</last_name>
    <phone>0220723659</phone>
    <email>dami0605@snu.ac.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ji-Hyun Lee, MD, PHd</last_name>
    <phone>0220723664</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heesoo Kim</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>March 5, 2019</last_update_submitted>
  <last_update_submitted_qc>March 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2019</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>principle investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Atelectasis</mesh_term>
  </condition_browse>
  <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/NCT03817177
org study id: 1812-111-998
nct id: NCT03817177
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
postoperative atelectasis observation by ultrasound after application of high flow nasal
      cannula oxygenation
After surgery, postoperative atelectasis observation by ultrasound grading comparison between
      application of conventional nasal prong and high flow nasal cannula device
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: lung sound score
time frame: 30 minutes after arrival of postanesthetic care unit
description: 0: Normal aeration (N): presence of lung sliding with A lines or fewer than two isolated B lines
Moderate loss of lung aeration: multiple well-defined B lines (B1 lines)
Severe loss of lung aeration: multiple coalescent B lines (B2 lines)
Lung consolidation (C): the presence of a tissue pattern characterized by dynamic air
arm group label: nasal prong
arm group type: Placebo Comparator
description: conventional nasal prong application after the surgery in postanesthetic care unit (PACU)
arm group label: high flow nasal cannula oxygenation
arm group type: Experimental
description: high flow nasal cannula application after the surgery in postanesthetic care unit (PACU)
intervention type: Procedure
intervention name: high flow nasal cannula oxygenation
description: high flow nasal cannula application in PACU
arm group label: high flow nasal cannula oxygenation
intervention type: Procedure
intervention name: nasal prong
description: conventional nasal prong application in PACU
arm group label: nasal prong
criteria: 
gender: All
minimum age: 1 Day
maximum age: 2 Years
healthy volunteers: No
last name: Hee-Soo Kim
role: Principal Investigator
affiliation: Seoul National University Children's Hospital
last name: Hee-Soo Kim, MD, Phd
phone: 0220723659
email: dami0605@snu.ac.kr
last name: Ji-Hyun Lee, MD, PHd
phone: 0220723664
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Hee-Soo Kim
investigator title: principle investigator
mesh term: Pulmonary Atelectasis
sharing ipd: Undecided