<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/NCT02260427</url>
  </required_header>
  <id_info>
    <org_study_id>3-2014-0157</org_study_id>
    <nct_id>NCT02260427</nct_id>
  </id_info>
  <brief_title>A Comparison of the I-gel and Self-pressurised Air-Q Intubating Laryngeal Airway (Air-Q sp) in the Elderly Patients</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>
      Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these&#xD;
      devices, the i-gel has been typically widely used. The self-pressurised air-Q intubating&#xD;
      laryngeal airway (air-Q sp) is newly developed supraglottic airway devices. It is a new&#xD;
      single-use device that may optimise the airway sealing while reducing the potential for&#xD;
      postoperative complications such as sore throat. The overall structure of the air-Q sp is&#xD;
      similar to the original air-Q, except the inflatable cuff. The aim of this randomized trial&#xD;
      was to compare the clinical performance of the i-gel and the air-Q sp in elderly patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>airway leak pressure measured after device insertion</measure>
    <time_frame>within 5min after 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 parameters (insertion time and ease of insertion)</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. Ease of insertion was graded from 1 to 4.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Supraglottic Airway Device</condition>
  <arm_group>
    <arm_group_label>the i-gel group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After induction of general anesthesia, the i-gel will be inserted according to randomly allocated group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the Air-Q sp group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After induction of general anesthesia, the air-Q sp will be inserted according to randomly allocated group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insertion of the i-gel</intervention_name>
    <description>After induction of general anesthesia, the i-gel will be inserted according to randomly allocated group.</description>
    <arm_group_label>the i-gel group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insertion of the air-Q sp</intervention_name>
    <arm_group_label>the Air-Q sp group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. elderly adult patients (65-90 of age) scheduled for elective surgery undergoing general&#xD;
        anesthesia using supraglottic airway&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. 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>65 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min-Soo Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research institute, Yonsei University College of Medicine, Seoul</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yonsei University College of Medicine, Gangnam Severance Hospital, 211 Eonju-ro, Gangnam-gu</name>
      <address>
        <city>Seoul</city>
        <zip>135-720</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>October 5, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>September 5, 2016</last_update_submitted>
  <last_update_submitted_qc>September 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>elective surgery</keyword>
  <keyword>undergoing general anesthesia</keyword>
  <keyword>elderly 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/NCT02260427
org study id: 3-2014-0157
nct id: NCT02260427
lead sponsor: 
has dmc: No
Supraglottic airway devices (SADs) are well established in anesthetic practice. Among these
      devices, the i-gel has been typically widely used. The self-pressurised air-Q intubating
      laryngeal airway (air-Q sp) 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
      similar to the original air-Q, except the inflatable cuff. The aim of this randomized trial
      was to compare the clinical performance of the i-gel and the air-Q sp in elderly patients
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Outcomes Assessor)
measure: airway leak pressure measured after device insertion
time frame: within 5min after 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 parameters (insertion time and ease of insertion)
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. Ease of insertion was graded from 1 to 4.
arm group label: the i-gel group
arm group type: Experimental
description: After induction of general anesthesia, the i-gel will be inserted according to randomly allocated group.
arm group label: the Air-Q sp group
arm group type: Active Comparator
description: After induction of general anesthesia, the air-Q sp will be inserted according to randomly allocated group.
intervention type: Device
intervention name: Insertion of the i-gel
description: After induction of general anesthesia, the i-gel will be inserted according to randomly allocated group.
arm group label: the i-gel group
intervention type: Device
intervention name: Insertion of the air-Q sp
arm group label: the Air-Q sp group
criteria: 
gender: All
minimum age: 65 Years
maximum age: 90 Years
healthy volunteers: No
last name: Min-Soo Kim, MD
role: Principal Investigator
affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research institute, Yonsei University College of Medicine, Seoul
facility: 
country: Korea, Republic of
responsible party type: Sponsor