<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/NCT01718782</url>
  </required_header>
  <id_info>
    <org_study_id>AN4111 292/4.23</org_study_id>
    <nct_id>NCT01718782</nct_id>
  </id_info>
  <brief_title>Laryngeal Mask Ambu Aura Once vs. Supreme in Children</brief_title>
  <official_title>Ventilation With Laryngeal Mask Ambu Aura Once vs. Supreme in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University Innsbruck</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is determine safety and efficiency of mechanical ventilation in&#xD;
      children with two different types of single use laryngeal masks (Ambu AuraOnce vs. LMA&#xD;
      Supreme). The main interest is leakage pressure of oropharynx and stomach. The null&#xD;
      hypothesis is that leakage pressures of Ambu AuraOnce and LMA Supreme are equivalent. The&#xD;
      alternative hypothesis is that there is a difference in leakage pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before starting surgery patients will be anesthetised and airway managed either with LMA Ambu&#xD;
      AuraOnce or Supreme. Ventilation parameters, stomach inflation, and hemodynamic parameters&#xD;
      will be measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Other studies with the same protocol have already published.&#xD;
  </why_stopped>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Leakage pressure [cmH2O]</measure>
    <time_frame>1min</time_frame>
    <description>After ventilation has been established the leakage pressure will be measured, ie 1min after establishing ventilation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficient ventilation [mL],</measure>
    <time_frame>3min</time_frame>
    <description>After ventilation has been established the efficient ventilation, tidal volume and stomach inflation will be measured, ie 3min after establishing ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tidal volume [mL],</measure>
    <time_frame>3 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stomach insufflation [yes or no]</measure>
    <time_frame>3 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Apnea</condition>
  <arm_group>
    <arm_group_label>laryngeal mask Ambu AuraOnce</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>laryngeal mask Ambu AuraOnce</description>
  </arm_group>
  <arm_group>
    <arm_group_label>laryngeal mask LMA Supreme</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>laryngeal mask LMA Supreme</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>laryngeal mask Ambu AuraOnce</intervention_name>
    <description>airway management and mechanical ventilation with laryngeal mask</description>
    <arm_group_label>laryngeal mask Ambu AuraOnce</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>laryngeal mask LMA Supreme</intervention_name>
    <description>airway management and mechanical ventilation with laryngeal mask</description>
    <arm_group_label>laryngeal mask LMA Supreme</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 1-10 years&#xD;
&#xD;
          -  ASA I - III&#xD;
&#xD;
          -  Elective procedure in general anaesthesia&#xD;
&#xD;
          -  Parental informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non fasting patient&#xD;
&#xD;
          -  Body mass index &gt; 35 kg/m2&#xD;
&#xD;
          -  Cervical spine pathologies or peripheral neurologic deficiences&#xD;
&#xD;
          -  Malformations of upper airway or head&#xD;
&#xD;
          -  Anamnestic hiatus hernia or esophageal reflux&#xD;
&#xD;
          -  Status post operation of stomach or esophagus&#xD;
&#xD;
          -  Recurrent respiratory infection or obstructive airway disease&#xD;
&#xD;
          -  Non elective procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Paal, MD,DESA,EDIC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Innsbruck, Department of Anaesthesia + Intensive Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <state>Tirol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>May 14, 2014</last_update_submitted>
  <last_update_submitted_qc>May 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University Innsbruck</investigator_affiliation>
    <investigator_full_name>Peter Paal</investigator_full_name>
    <investigator_title>Peter Paal, MD, DESA, EDIC</investigator_title>
  </responsible_party>
  <keyword>laryngeal mask, leakage pressure, ventilation</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/NCT01718782
org study id: AN4111 292/4.23
nct id: NCT01718782
lead sponsor: 
has dmc: Yes
The purpose of this study is determine safety and efficiency of mechanical ventilation in
      children with two different types of single use laryngeal masks (Ambu AuraOnce vs. LMA
      Supreme). The main interest is leakage pressure of oropharynx and stomach. The null
      hypothesis is that leakage pressures of Ambu AuraOnce and LMA Supreme are equivalent. The
      alternative hypothesis is that there is a difference in leakage pressure.
Before starting surgery patients will be anesthetised and airway managed either with LMA Ambu
      AuraOnce or Supreme. Ventilation parameters, stomach inflation, and hemodynamic parameters
      will be measured.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Leakage pressure [cmH2O]
time frame: 1min
description: After ventilation has been established the leakage pressure will be measured, ie 1min after establishing ventilation
measure: Efficient ventilation [mL],
time frame: 3min
description: After ventilation has been established the efficient ventilation, tidal volume and stomach inflation will be measured, ie 3min after establishing ventilation
measure: tidal volume [mL],
time frame: 3 minutes
measure: stomach insufflation [yes or no]
time frame: 3 minutes
arm group label: laryngeal mask Ambu AuraOnce
arm group type: Active Comparator
description: laryngeal mask Ambu AuraOnce
arm group label: laryngeal mask LMA Supreme
arm group type: Active Comparator
description: laryngeal mask LMA Supreme
intervention type: Device
intervention name: laryngeal mask Ambu AuraOnce
description: airway management and mechanical ventilation with laryngeal mask
arm group label: laryngeal mask Ambu AuraOnce
intervention type: Device
intervention name: laryngeal mask LMA Supreme
description: airway management and mechanical ventilation with laryngeal mask
arm group label: laryngeal mask LMA Supreme
criteria: 
gender: All
minimum age: 1 Year
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Paal, MD,DESA,EDIC
role: Principal Investigator
affiliation: University Hospital Innsbruck, Department of Anaesthesia + Intensive Care
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University Innsbruck
investigator full name: Peter Paal
investigator title: Peter Paal, MD, DESA, EDIC