<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/NCT02979171</url>
  </required_header>
  <id_info>
    <org_study_id>71146310</org_study_id>
    <nct_id>NCT02979171</nct_id>
  </id_info>
  <brief_title>Comparison in Difficult Airway Scenario Induced in Patients With Laryngeal Mask Airway (LMA)-Classic™, LMA™ - Flexible and LMA - Proseal™</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marmara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marmara University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Supraglottic airway tools, one of the tools used in the management of the difficult airway.&#xD;
      American Society of Anesthesiologists and the Difficult Airway Society of the United Kingdom&#xD;
      airway management algorithms have included the LMA. In our study investigators aimed to&#xD;
      determine which one will show the best performance with supraglottic airway means that LMA -&#xD;
      Classic, LMA - Flexible and LMA - ProSeal in patients that difficult airway scenarios created&#xD;
      with attaching collar.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>insertion time and attempts in min.</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>oropharyngeal leak pressure in cmH20.</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>fiberoptic view grade by Brimacombe and Berry bronchoscopy score</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>score1-4 (easy to difficult)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Difficult Airway</condition>
  <arm_group>
    <arm_group_label>LMA-Classic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>airway management with LMA-Classic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LMA-Flexible</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>airway management with LMA-Flexible</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LMA-Proseal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>airway management with LMA-Proseal</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laryngeal Mask Airway Classic</intervention_name>
    <arm_group_label>LMA-Classic</arm_group_label>
    <arm_group_label>LMA-Flexible</arm_group_label>
    <arm_group_label>LMA-Proseal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Without a history of difficult intubation, supine position, does not require tracheal&#xD;
             intubation, undergo elective surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  High aspiration risk, who take more than 4 hours surgery&#xD;
&#xD;
          -  Body mass index greater than of 35 kg/m²&#xD;
&#xD;
          -  Disease related to the cervical spine&#xD;
&#xD;
          -  The mouth opening is less than 20 mm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul Science University</name>
      <address>
        <city>Istanbul</city>
        <state>Şişli</state>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>April 5, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>November 28, 2016</last_update_submitted>
  <last_update_submitted_qc>November 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT02979171
org study id: 71146310
nct id: NCT02979171
lead sponsor: 
has dmc: No
Supraglottic airway tools, one of the tools used in the management of the difficult airway.
      American Society of Anesthesiologists and the Difficult Airway Society of the United Kingdom
      airway management algorithms have included the LMA. In our study investigators aimed to
      determine which one will show the best performance with supraglottic airway means that LMA -
      Classic, LMA - Flexible and LMA - ProSeal in patients that difficult airway scenarios created
      with attaching collar.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: insertion time and attempts in min.
time frame: through study completion, an average of 6 months
measure: oropharyngeal leak pressure in cmH20.
time frame: through study completion, an average of 6 months
measure: fiberoptic view grade by Brimacombe and Berry bronchoscopy score
time frame: through study completion, an average of 6 months
description: score1-4 (easy to difficult)
arm group label: LMA-Classic
arm group type: Active Comparator
description: airway management with LMA-Classic
arm group label: LMA-Flexible
arm group type: Active Comparator
description: airway management with LMA-Flexible
arm group label: LMA-Proseal
arm group type: Active Comparator
description: airway management with LMA-Proseal
intervention type: Device
intervention name: Laryngeal Mask Airway Classic
arm group label: LMA-Classic
arm group label: LMA-Flexible
arm group label: LMA-Proseal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Sponsor
sharing ipd: Undecided