<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/NCT02206438</url>
  </required_header>
  <id_info>
    <org_study_id>3-2014-0081</org_study_id>
    <nct_id>NCT02206438</nct_id>
  </id_info>
  <brief_title>The Clinical Efficacy of Supraglottic Airway Device, Self-pressurized Air-Q Intubating Laryngeal Airway (ILA -SP) in Adult Patients: Comparison With Classic-laryngeal Airway (c-LMA)</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these&#xD;
      devices ,classic laryngeal airway has been typically widely used. The self-pressurised air-Q&#xD;
      (air-Q) is newly developed supraglottic airway devices. It is a new single-use device that&#xD;
      may optimise the airway sealing while reducing the potential for postoperative complications&#xD;
      such as sore throat. The overall structure of the air-Q SP is identical to the original&#xD;
      air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to&#xD;
      compare the clinical performance of the classic LMA and the air-Q SP.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>airway leak pressure measured after device insertion</measure>
    <time_frame>within 5min to 10 min insertion of each device</time_frame>
    <description>Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insertion time</measure>
    <time_frame>During and 1 min after insertion of each device</time_frame>
    <description>Insertion time was defined as the time from the attending anesthesiologist picking up the LMA until the confirmation on capnography.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Ease of insertion</measure>
    <time_frame>During and 1 min after insertion of each device</time_frame>
    <description>Ease of insertion was graded from 1 to 4.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>1)C-LMA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>2)Air-Q group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insertion of C-LMA</intervention_name>
    <description>After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.</description>
    <arm_group_label>1)C-LMA group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insertion of air-Q according</intervention_name>
    <description>After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.</description>
    <arm_group_label>2)Air-Q group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (20-75 of age) scheduled for elective surgery of short duration (less&#xD;
             than 2 hr) undergoing general anesthesia using supraglottic airway&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a potentially difficult airway, risk of aspiration such as&#xD;
             gastroesophageal reflux disease, or active upper respiratory tract infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Human research Protection Center, Gangnam Severance Hospital,</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>supraglottic airway devices</keyword>
  <keyword>the classic laryngeal mask airway</keyword>
  <keyword>the self-pressurised air-Q intubating laryngeal airway in adult patients</keyword>
  <keyword>elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway in adult patients</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/NCT02206438
org study id: 3-2014-0081
nct id: NCT02206438
lead sponsor: 
has dmc: Yes
Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these
      devices ,classic laryngeal airway has been typically widely used. The self-pressurised air-Q
      (air-Q) is newly developed supraglottic airway devices. It is a new single-use device that
      may optimise the airway sealing while reducing the potential for postoperative complications
      such as sore throat. The overall structure of the air-Q SP is identical to the original
      air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to
      compare the clinical performance of the classic LMA and the air-Q SP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: airway leak pressure measured after device insertion
time frame: within 5min to 10 min insertion of each device
description: Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.
measure: Insertion time
time frame: During and 1 min after insertion of each device
description: Insertion time was defined as the time from the attending anesthesiologist picking up the LMA until the confirmation on capnography.
measure: Ease of insertion
time frame: During and 1 min after insertion of each device
description: Ease of insertion was graded from 1 to 4.
arm group label: 1)C-LMA group
arm group type: Experimental
arm group label: 2)Air-Q group
arm group type: Active Comparator
intervention type: Device
intervention name: Insertion of C-LMA
description: After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.
arm group label: 1)C-LMA group
intervention type: Device
intervention name: Insertion of air-Q according
description: After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.
arm group label: 2)Air-Q group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor