<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/NCT03294226</url>
  </required_header>
  <id_info>
    <org_study_id>S2017-1229</org_study_id>
    <nct_id>NCT03294226</nct_id>
  </id_info>
  <brief_title>Comparison of AuraGain With I-gel for Pediatric Patients</brief_title>
  <official_title>A Randomized Trial of Ambu® AuraGain™ Versus I-gel® in Young Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</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>
      Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group.&#xD;
      After anesthetic induction without neuromuscular blocking agent, assigned device in inserted&#xD;
      by skillful anesthesiologist. The outcome measures are recorded and analysed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">March 24, 2018</completion_date>
  <primary_completion_date type="Actual">March 23, 2018</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>requirement of additional airway maneuver</measure>
    <time_frame>during placement/maintenance of the device</time_frame>
    <description>including adjustment of head/neck position or insertion depth and taping of the device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>insertion time</measure>
    <time_frame>during placement of the device</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>success rate</measure>
    <time_frame>during placement of the device</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ease of gastric tube insertion</measure>
    <time_frame>within 10 minutes after device insertion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse effect at operating room</measure>
    <time_frame>during anesthesia</time_frame>
    <description>aspiration of gastric fluid, hypoxia, SpO2&lt;90%, bronchospasm, dental/tongue/lip trauma, staining of blood on the removed device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative adverse effect</measure>
    <time_frame>within postoperative 24 hours</time_frame>
    <description>sore throat, hoarseness, airway obstruction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fiberoptic view of glottis</measure>
    <time_frame>within 10 minutes after device insertion</time_frame>
    <description>Brimacombe score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oropharyngeal leak pressure</measure>
    <time_frame>at 1 minute after device insertion, at 10 minutes after device insertion</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>General Anesthesia</condition>
  <arm_group>
    <arm_group_label>AuraGain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After anesthetic induction, AuraGain is inserted for airway management. Size of the device is selected according to the manufacturer's recommendation; size 1.5 for 5-10kg, size 2 for 10-20kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>I-gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After anesthetic induction, I-gel is inserted for airway management. Size of the device is selected according to the patient's weight; size 1.5 for 5-10kg, size 2 for 10-20kg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AuraGain</intervention_name>
    <description>After anesthetic induction without neuromuscular blocking agent, AuraGain is inserted.</description>
    <arm_group_label>AuraGain</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>I-gel</intervention_name>
    <description>After anesthetic induction without neuromuscular blocking agent, I-gel is inserted.</description>
    <arm_group_label>I-gel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA physical status: 1-3&#xD;
&#xD;
          -  age: from 6 months to 6 year&#xD;
&#xD;
          -  body weight: 5-20kg&#xD;
&#xD;
          -  patients undergoing upper/lower extremity surgery at supine position&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who do not want to participate in this study&#xD;
&#xD;
          -  patients with known difficult airway including congenital facial anomaly or history of&#xD;
             difficult airway management&#xD;
&#xD;
          -  patients with aspiration risk (gastrointestinal stenosis or stricture)&#xD;
&#xD;
          -  patients with symptom of upper respiratory infection on the day of surgery&#xD;
&#xD;
          -  patients scheduled for day surgery&#xD;
&#xD;
          -  patients judged as not eligible by researchers for other reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Won Uk Koh, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ulsan, College of Medicine, Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>May 10, 2018</last_update_submitted>
  <last_update_submitted_qc>May 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Hajung Kim</investigator_full_name>
    <investigator_title>Clinical Instructor</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/NCT03294226
org study id: S2017-1229
nct id: NCT03294226
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group.
      After anesthetic induction without neuromuscular blocking agent, assigned device in inserted
      by skillful anesthesiologist. The outcome measures are recorded and analysed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: requirement of additional airway maneuver
time frame: during placement/maintenance of the device
description: including adjustment of head/neck position or insertion depth and taping of the device
measure: insertion time
time frame: during placement of the device
measure: success rate
time frame: during placement of the device
measure: ease of gastric tube insertion
time frame: within 10 minutes after device insertion
measure: adverse effect at operating room
time frame: during anesthesia
description: aspiration of gastric fluid, hypoxia, SpO2<90%, bronchospasm, dental/tongue/lip trauma, staining of blood on the removed device
measure: postoperative adverse effect
time frame: within postoperative 24 hours
description: sore throat, hoarseness, airway obstruction
measure: fiberoptic view of glottis
time frame: within 10 minutes after device insertion
description: Brimacombe score
measure: oropharyngeal leak pressure
time frame: at 1 minute after device insertion, at 10 minutes after device insertion
arm group label: AuraGain
arm group type: Experimental
description: After anesthetic induction, AuraGain is inserted for airway management. Size of the device is selected according to the manufacturer's recommendation; size 1.5 for 5-10kg, size 2 for 10-20kg.
arm group label: I-gel
arm group type: Active Comparator
description: After anesthetic induction, I-gel is inserted for airway management. Size of the device is selected according to the patient's weight; size 1.5 for 5-10kg, size 2 for 10-20kg.
intervention type: Device
intervention name: AuraGain
description: After anesthetic induction without neuromuscular blocking agent, AuraGain is inserted.
arm group label: AuraGain
intervention type: Device
intervention name: I-gel
description: After anesthetic induction without neuromuscular blocking agent, I-gel is inserted.
arm group label: I-gel
criteria: 
gender: All
minimum age: 6 Months
maximum age: 6 Years
healthy volunteers: No
last name: Won Uk Koh, M.D., Ph.D.
role: Principal Investigator
affiliation: University of Ulsan, College of Medicine, Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Hajung Kim
investigator title: Clinical Instructor
sharing ipd: Undecided