<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/NCT02259569</url>
  </required_header>
  <id_info>
    <org_study_id>4-2014-0594</org_study_id>
    <nct_id>NCT02259569</nct_id>
  </id_info>
  <brief_title>Comparison of Peak Airway Pressure and Gastric Insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation With I-Gel in Pediatric Patient</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare peak airway pressure and gastric insufflation in&#xD;
      Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric&#xD;
      patient&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastric insufflation determined by increase of cross sectional area of gastric antrum, measured by ultrasonography.</measure>
    <time_frame>1 min after I-gel insertion</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>oropharyngeal leak pressure</measure>
    <time_frame>1 min after caudal block</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FOB grade</measure>
    <time_frame>1 min after I-gel insertion</time_frame>
    <description>grade 1= only the vocal cords visible, 2= vocal cords and epiglottis visible, 3= only the epiglottis visible, 4= vocal cords and epiglottis not visible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>peak airway pressure</measure>
    <time_frame>1 min after I-gel insertion</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>dynamic compliance</measure>
    <time_frame>1 min after end of surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>typical gurgle or whoosh sound</measure>
    <time_frame>1 min after caudal block</time_frame>
    <description>gastric insufflation determined by continuous epigastric auscultation</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Pediatric Urologic Surgeries</condition>
  <arm_group>
    <arm_group_label>PCV group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in pressure-controlled mode.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VCV group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in volume-controlled mode.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pressure-controlled ventilation</intervention_name>
    <arm_group_label>PCV group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Volume-controlled ventilation</intervention_name>
    <arm_group_label>VCV group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ① ASA I-II patients aged between 1 and 7 year undergoing elective urologic surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  parent refusal&#xD;
&#xD;
               -  clinically significant respiratory disease ③ congenital airway abnormalities,&#xD;
                  oropharyngeal or facial pathology ④ risk of aspiration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>October 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>April 23, 2015</last_update_submitted>
  <last_update_submitted_qc>April 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastric insufflation</keyword>
  <keyword>I-gel</keyword>
  <keyword>Peak airway pressure</keyword>
  <keyword>Pressure-controlled ventilation</keyword>
  <keyword>Volume-Controlled Ventilation</keyword>
  <keyword>pediatric patient</keyword>
  <!-- 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/NCT02259569
org study id: 4-2014-0594
nct id: NCT02259569
lead sponsor: 
has dmc: No
The purpose of this study is to compare peak airway pressure and gastric insufflation in
      Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric
      patient
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Gastric insufflation determined by increase of cross sectional area of gastric antrum, measured by ultrasonography.
time frame: 1 min after I-gel insertion
measure: oropharyngeal leak pressure
time frame: 1 min after caudal block
measure: FOB grade
time frame: 1 min after I-gel insertion
description: grade 1= only the vocal cords visible, 2= vocal cords and epiglottis visible, 3= only the epiglottis visible, 4= vocal cords and epiglottis not visible
measure: peak airway pressure
time frame: 1 min after I-gel insertion
measure: dynamic compliance
time frame: 1 min after end of surgery
measure: typical gurgle or whoosh sound
time frame: 1 min after caudal block
description: gastric insufflation determined by continuous epigastric auscultation
arm group label: PCV group
arm group type: Experimental
description: After insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in pressure-controlled mode.
arm group label: VCV group
arm group type: Active Comparator
description: After insertion of I-gel, mechanical ventilation of the lungs was commenced. Mechanical ventilator was set to obtain a tidal volume of 8ml/kg in volume-controlled mode.
intervention type: Other
intervention name: Pressure-controlled ventilation
arm group label: PCV group
intervention type: Other
intervention name: Volume-controlled ventilation
arm group label: VCV group
criteria: 
gender: All
minimum age: 6 Months
maximum age: 7 Years
healthy volunteers: No
responsible party type: Sponsor