<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/NCT01692522</url>
  </required_header>
  <id_info>
    <org_study_id>093/12</org_study_id>
    <nct_id>NCT01692522</nct_id>
  </id_info>
  <brief_title>Comparison of the Laryngeal Mask Ambu Aura-i Versus AirQ in Children</brief_title>
  <official_title>Comparison of the Pediatric Intubation on Laryngeal Masks Ambu Aira-i and AirQ for Simulated Blind Intubation in Anesthetized Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will evaluate the first attempt visualized blind intubation through an Ambu&#xD;
      Aura-i versus an AirQ.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After induction of anesthesia, one of the 2 laryngeal masks (Ambu or AirQ) is going to be&#xD;
      inserted. Following this, a tracheal tube is mounted on a fiberoptic scope with the tip of&#xD;
      the scope behind the tip of the tube. This way, the tracheal tube is not guided by the scope,&#xD;
      but the scope visualizes the course of the tracheal tube in the laryngeal mask and the&#xD;
      glottic opening as if the tracheal tube was advanced blindly: Visualized blind intubation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>First attempt visualized blind intubation success rate</measure>
    <time_frame>how many seconds needed</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall intubation success rate</measure>
    <time_frame>how many seconds needed</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Intubation; Difficult</condition>
  <arm_group>
    <arm_group_label>Ambu Aura-i</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intubation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AirQ</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intubation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intubation</intervention_name>
    <description>visualized blind intubation</description>
    <arm_group_label>AirQ</arm_group_label>
    <arm_group_label>Ambu Aura-i</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  0-16 years&#xD;
&#xD;
          -  max 50kg&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  risk of aspiration&#xD;
&#xD;
          -  known difficult airway&#xD;
&#xD;
          -  congenital malformations respiratory tract&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Greif, MD MME FERC</last_name>
    <role>Study Chair</role>
    <affiliation>University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bern University Hospital</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>August 14, 2014</last_update_submitted>
  <last_update_submitted_qc>August 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Insel Gruppe AG, University Hospital Bern</investigator_affiliation>
    <investigator_full_name>Lorenz Theiler</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT01692522
org study id: 093/12
nct id: NCT01692522
lead sponsor: 
has dmc: No
The investigators will evaluate the first attempt visualized blind intubation through an Ambu
      Aura-i versus an AirQ.
After induction of anesthesia, one of the 2 laryngeal masks (Ambu or AirQ) is going to be
      inserted. Following this, a tracheal tube is mounted on a fiberoptic scope with the tip of
      the scope behind the tip of the tube. This way, the tracheal tube is not guided by the scope,
      but the scope visualizes the course of the tracheal tube in the laryngeal mask and the
      glottic opening as if the tracheal tube was advanced blindly: Visualized blind intubation
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: First attempt visualized blind intubation success rate
time frame: how many seconds needed
measure: Overall intubation success rate
time frame: how many seconds needed
arm group label: Ambu Aura-i
arm group type: Experimental
description: intubation
arm group label: AirQ
arm group type: Active Comparator
description: intubation
intervention type: Procedure
intervention name: Intubation
description: visualized blind intubation
arm group label: AirQ
arm group label: Ambu Aura-i
criteria: 
gender: All
minimum age: N/A
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Greif, MD MME FERC
role: Study Chair
affiliation: University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Insel Gruppe AG, University Hospital Bern
investigator full name: Lorenz Theiler
investigator title: Principal Investigator