<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/NCT02197377</url>
  </required_header>
  <id_info>
    <org_study_id>178/2009</org_study_id>
    <nct_id>NCT02197377</nct_id>
  </id_info>
  <brief_title>The Laryngeal Mask Airway in Edentulous Geriatric Patients</brief_title>
  <official_title>Comparison of The Laryngeal Mask Airway Supreme™ Versus Unique™ in Edentulous Geriatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dokuz Eylul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dokuz Eylul University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      With an aging population a prevalence of edentulous patients increased above 60 % among&#xD;
      individuals aged ≥65 yr. Face mask ventilation of these edentulous patients is often&#xD;
      difficult because of the inadequate fitting of the standard mask to the face. In addition,&#xD;
      because of a reduction in muscle tone under general anesthesia, the air space in the&#xD;
      oropharynx is reduced, and posterior displacement of the tongue, soft palate and epiglottis&#xD;
      tend to close the airway. The laryngeal mask airway (LMA) provides a better alternative to&#xD;
      the standard face mask if the facial contours of the patient are not suited to the standard&#xD;
      face mask. It is more difficult to perform bag-mask ventilation in edentulous patients than&#xD;
      in patients with intact dentition. The laryngeal mask airway (LMA) provides a better&#xD;
      alternative to the standard face mask if the facial contours of the patient are not suited to&#xD;
      the standard face mask.&#xD;
&#xD;
      We aimed to compare the routinely used laryngeal mask airway in our clinic, the LMA Unique™&#xD;
      with the newly released LMA Supreme™ in edentulous elderly patients for the success in first&#xD;
      attempt insertion, ease and time of insertion, and oropharyngeal leak pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After Ethical Committee approval and written informed consent were obtained, sixty edentulous&#xD;
      patients (American Society of Anesthesiologists physical status (ASA) grade I-III, aged over&#xD;
      65 years) undergoing elective surgery were included into the study. Patients with dentures&#xD;
      had to remove their dentures before surgery at the ward. The supraglottic airway device was&#xD;
      inserted into each patient in a random order. A statistician independent of the clinical&#xD;
      investigators generated the randomization sequence using a computerized program. Patients&#xD;
      were excluded if they had a known or predicted difficult airway, a body mass index &gt; 35&#xD;
      kg/m2, or were at risk of aspiration. All cases were conducted by anesthetists who had&#xD;
      experience over 5 years of LMA insertion.&#xD;
&#xD;
      Demographic parameters, Mallampati classification and the duration of surgery were recorded.&#xD;
      Patients were routinely monitored using ECG, non-invasive blood pressure measurement, pulse&#xD;
      oximetry and end-tidal carbon dioxide tension. Depth of anesthesia was monitored with&#xD;
      bispectral index (BIS).&#xD;
&#xD;
      Patients were premedicated with midazolam 0.02 mg/kg when venous access was obtained. After 3&#xD;
      min preoxygenation with 100 % oxygen via face mask, anesthesia was induced with fentanyl 1-2&#xD;
      µg/kg and propofol 1-2 mg/kg. When the BIS value was 40-60 the predetermined supraglottic&#xD;
      airway device was inserted according to the manufacturer's recommendations. The supraglottic&#xD;
      airway devices were deflated fully before insertion. Size 4 LMA was used for those with a&#xD;
      weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device&#xD;
      was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of&#xD;
      60 cm H2O.&#xD;
&#xD;
      An effective airway was defined as the presence of normal thoracoabdominal movement and a&#xD;
      square-wave end-tidal carbon dioxide trace. General anesthesia was maintained with&#xD;
      sevoflurane, O2 and N2O.&#xD;
&#xD;
      Insertion time was defined as the time from picking up the airway device until connection to&#xD;
      the airway circuit. Ease of insertion was graded by the attending anesthesiologist as easy,&#xD;
      fair or difficult. If after three attempts insertion was still not successful, the other&#xD;
      device was used. If insertion of the other device also failed the patient was endotracheally&#xD;
      intubated.&#xD;
&#xD;
      Before the oropharyngeal leak test was carried out, the face of the patient was covered so&#xD;
      that the observer was blinded to the airway device. The oropharyngeal leak pressure was&#xD;
      determined by transiently stopping ventilation and closing the adjustable pressure-limiting&#xD;
      valve with a fresh gas flow of 3 L/min until airway pressure reached a steady state and a&#xD;
      voice of leakage was heard. The airway pressure was not allowed to exceed 40 cm H2O.&#xD;
&#xD;
      After successful placement of the LMA Supreme™, a 12 French gauge gastric catheter was&#xD;
      inserted via the gastric channel.&#xD;
&#xD;
      Any episode of hypoxemia (SpO2 &lt; 90%), aspiration or regurgitation,bronchospasm and airway&#xD;
      obstruction were documented. After removal of the LMA, it was examined for the presence of&#xD;
      visible blood.&#xD;
&#xD;
      In the postanesthesia care unit, a research assistant, who was blinded to the group&#xD;
      allocation, interviewed the patients using a predetermined questionnaire to collect data on&#xD;
      the postoperative pharyngolaryngeal adverse events. The presence or absence of sore throat,&#xD;
      dysphonia and dysphagia was assessed at 1 and 24 h postoperatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2009</start_date>
  <completion_date type="Actual">May 2010</completion_date>
  <primary_completion_date type="Actual">April 2010</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>Screening</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>First Attempt's Success Rate of Insertion</measure>
    <time_frame>after anaesthesia induction</time_frame>
    <description>Edentulous elderly patients for the success in first attempt insertion, ease and time of insertion (second).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oropharyngeal Leak Pressure</measure>
    <time_frame>before surgery</time_frame>
    <description>The aim of this study is to compare on the oropharyngeal leak pressure in LMA Unique™ and LMA Supreme™ applications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Anaesthesia</condition>
  <arm_group>
    <arm_group_label>Group LMA Unique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.The oropharyngeal leak pressure was determined by transiently stopping ventilation and closing the adjustable pressure-limiting valve with a fresh gas flow of 3 L/min until airway pressure reached a steady state and a voice of leakage was heard. The airway pressure was not allowed to exceed 40 cm H2O.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group LMA Supreme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.The oropharyngeal leak pressure was determined by transiently stopping ventilation and closing the adjustable pressure-limiting valve with a fresh gas flow of 3 L/min until airway pressure reached a steady state and a voice of leakage was heard. The airway pressure was not allowed to exceed 40 cm H2O.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Group LMA Unique™</intervention_name>
    <description>The supraglottic airway devices were deflated fully before insertion. After placement an effective airway was defined as the presence of normal thoracoabdominal movement and a square-wave end-tidal carbon dioxide trace.</description>
    <arm_group_label>Group LMA Unique</arm_group_label>
    <other_name>Laryngeal Mask Airway Unique</other_name>
    <other_name>LMA Unique (The Laryngeal Mask Company Limited, Singapore)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Group LMA Supreme™</intervention_name>
    <description>The supraglottic airway devices were deflated fully before insertion.The supraglottic airway devices were deflated fully before insertion. After placement an effective airway was defined as the presence of normal thoracoabdominal movement and a square-wave end-tidal carbon dioxide trace.</description>
    <arm_group_label>Group LMA Supreme</arm_group_label>
    <other_name>Laryngeal Mask Airway Supreme</other_name>
    <other_name>Teleflex, The Laryngeal Mask Company Limited, Singapore</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
          -  65 years and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any neck or upper respiratory pathology&#xD;
&#xD;
          -  Those at risk of gastric content regurgitation/aspiration (previous upper&#xD;
             gastro-intestina system surgery, known hiatus hernia, gastroesophageal reflux, history&#xD;
             of peptic ulcer, full stomach, pregnancy)&#xD;
&#xD;
          -  Possibility of and those with history of difficult intubation (history of impossible&#xD;
             intubation, Mallampati classification 3-4, sterno mental distance less than 12 cm,&#xD;
             thyromental distance less than 6 cm, head extension less than 90 degrees, mouth&#xD;
             opening less than 1.5 cm)&#xD;
&#xD;
          -  Those with low pulmonary compliance or high airway resistance (morbid obesity, lung&#xD;
             disease)&#xD;
&#xD;
          -  Throat pain, dysphagia and dysphonia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>TANGUL KILIÇ, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>SEMİH KUCUKGUCLU, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation</name>
      <address>
        <city>Izmi̇r</city>
        <state>Narlıdere</state>
        <zip>35320</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <results_first_submitted>April 26, 2015</results_first_submitted>
  <results_first_submitted_qc>December 20, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 19, 2018</results_first_posted>
  <last_update_submitted>December 20, 2017</last_update_submitted>
  <last_update_submitted_qc>December 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dokuz Eylul University</investigator_affiliation>
    <investigator_full_name>Sule Ozbilgin</investigator_full_name>
    <investigator_title>Anaesthesiology and Reanimation</investigator_title>
  </responsible_party>
  <keyword>Laryngeal mask airway, edentulous geriatric patient</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mouth, Edentulous</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group LMA Unique</title>
          <description>The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.&#xD;
Group LMA Supreme™: The supraglottic airway devices were deflated fully before insertion.</description>
        </group>
        <group group_id="P2">
          <title>Group LMA Supreme</title>
          <description>The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.&#xD;
Group LMA Unique™: The supraglottic airway devices were deflated fully before insertion.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Insertion Failure</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group LMA Unique</title>
          <description>The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.&#xD;
Group LMA Supreme™: The supraglottic airway devices were deflated fully before insertion.</description>
        </group>
        <group group_id="B2">
          <title>Group LMA Supreme</title>
          <description>The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.&#xD;
Group LMA Unique™: The supraglottic airway devices were deflated fully before insertion.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="57"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>Three patients LMA supreme insertion failure occurred and these patients were excluded from further analysis.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Turkey</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>First Attempt's Success Rate of Insertion</title>
        <description>Edentulous elderly patients for the success in first attempt insertion, ease and time of insertion (second).</description>
        <time_frame>after anaesthesia induction</time_frame>
        <population>Non parametric data between groups were analyzed with the X2-test, while parametric data were compared with unpaired t-test. P &lt; 0.05 was considered significant. 3 LMA insertion failed in Group LMA Supreme. Total 27 patients included analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Group LMA Unique</title>
            <description>The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.&#xD;
Group LMA Supreme™: The supraglottic airway devices were deflated fully before insertion.</description>
          </group>
          <group group_id="O2">
            <title>Group LMA Supreme</title>
            <description>The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.&#xD;
Group LMA Unique™: The supraglottic airway devices were deflated fully before insertion.</description>
          </group>
        </group_list>
        <measure>
          <title>First Attempt's Success Rate of Insertion</title>
          <description>Edentulous elderly patients for the success in first attempt insertion, ease and time of insertion (second).</description>
          <population>Non parametric data between groups were analyzed with the X2-test, while parametric data were compared with unpaired t-test. P &lt; 0.05 was considered significant. 3 LMA insertion failed in Group LMA Supreme. Total 27 patients included analysis.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.3"/>
                    <measurement group_id="O2" value="86.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oropharyngeal Leak Pressure</title>
        <description>The aim of this study is to compare on the oropharyngeal leak pressure in LMA Unique™ and LMA Supreme™ applications</description>
        <time_frame>before surgery</time_frame>
        <population>Non parametric data between groups were analyzed with the X2-test, while parametric data were compared with unpaired t-test. P &lt; 0.05 was considered significant.</population>
        <group_list>
          <group group_id="O1">
            <title>Group LMA Unique</title>
            <description>The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.&#xD;
Group LMA Supreme™: The supraglottic airway devices were deflated fully before insertion.</description>
          </group>
          <group group_id="O2">
            <title>Group LMA Supreme</title>
            <description>The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.&#xD;
Group LMA Unique™: The supraglottic airway devices were deflated fully before insertion.</description>
          </group>
        </group_list>
        <measure>
          <title>Oropharyngeal Leak Pressure</title>
          <description>The aim of this study is to compare on the oropharyngeal leak pressure in LMA Unique™ and LMA Supreme™ applications</description>
          <population>Non parametric data between groups were analyzed with the X2-test, while parametric data were compared with unpaired t-test. P &lt; 0.05 was considered significant.</population>
          <units>cm H20</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.1" spread="6.33"/>
                    <measurement group_id="O2" value="20.56" spread="8.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Group LMA Unique</title>
          <description>The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.&#xD;
Group LMA Supreme™: The supraglottic airway devices were deflated fully before insertion.</description>
        </group>
        <group group_id="E2">
          <title>Group LMA Supreme</title>
          <description>The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.&#xD;
Group LMA Unique™: The supraglottic airway devices were deflated fully before insertion.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Anaesthesiology and Reanimation</name_or_title>
      <organization>DorkuzEU</organization>
      <phone>0905055252901</phone>
      <email>ozbilginsule@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02197377
org study id: 178/2009
nct id: NCT02197377
lead sponsor: 
has dmc: No
With an aging population a prevalence of edentulous patients increased above 60 % among
      individuals aged ≥65 yr. Face mask ventilation of these edentulous patients is often
      difficult because of the inadequate fitting of the standard mask to the face. In addition,
      because of a reduction in muscle tone under general anesthesia, the air space in the
      oropharynx is reduced, and posterior displacement of the tongue, soft palate and epiglottis
      tend to close the airway. The laryngeal mask airway (LMA) provides a better alternative to
      the standard face mask if the facial contours of the patient are not suited to the standard
      face mask. It is more difficult to perform bag-mask ventilation in edentulous patients than
      in patients with intact dentition. The laryngeal mask airway (LMA) provides a better
      alternative to the standard face mask if the facial contours of the patient are not suited to
      the standard face mask.

      We aimed to compare the routinely used laryngeal mask airway in our clinic, the LMA Unique™
      with the newly released LMA Supreme™ in edentulous elderly patients for the success in first
      attempt insertion, ease and time of insertion, and oropharyngeal leak pressure.
After Ethical Committee approval and written informed consent were obtained, sixty edentulous
      patients (American Society of Anesthesiologists physical status (ASA) grade I-III, aged over
      65 years) undergoing elective surgery were included into the study. Patients with dentures
      had to remove their dentures before surgery at the ward. The supraglottic airway device was
      inserted into each patient in a random order. A statistician independent of the clinical
      investigators generated the randomization sequence using a computerized program. Patients
      were excluded if they had a known or predicted difficult airway, a body mass index > 35
      kg/m2, or were at risk of aspiration. All cases were conducted by anesthetists who had
      experience over 5 years of LMA insertion.

      Demographic parameters, Mallampati classification and the duration of surgery were recorded.
      Patients were routinely monitored using ECG, non-invasive blood pressure measurement, pulse
      oximetry and end-tidal carbon dioxide tension. Depth of anesthesia was monitored with
      bispectral index (BIS).

      Patients were premedicated with midazolam 0.02 mg/kg when venous access was obtained. After 3
      min preoxygenation with 100 % oxygen via face mask, anesthesia was induced with fentanyl 1-2
      µg/kg and propofol 1-2 mg/kg. When the BIS value was 40-60 the predetermined supraglottic
      airway device was inserted according to the manufacturer's recommendations. The supraglottic
      airway devices were deflated fully before insertion. Size 4 LMA was used for those with a
      weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device
      was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of
      60 cm H2O.

      An effective airway was defined as the presence of normal thoracoabdominal movement and a
      square-wave end-tidal carbon dioxide trace. General anesthesia was maintained with
      sevoflurane, O2 and N2O.

      Insertion time was defined as the time from picking up the airway device until connection to
      the airway circuit. Ease of insertion was graded by the attending anesthesiologist as easy,
      fair or difficult. If after three attempts insertion was still not successful, the other
      device was used. If insertion of the other device also failed the patient was endotracheally
      intubated.

      Before the oropharyngeal leak test was carried out, the face of the patient was covered so
      that the observer was blinded to the airway device. The oropharyngeal leak pressure was
      determined by transiently stopping ventilation and closing the adjustable pressure-limiting
      valve with a fresh gas flow of 3 L/min until airway pressure reached a steady state and a
      voice of leakage was heard. The airway pressure was not allowed to exceed 40 cm H2O.

      After successful placement of the LMA Supreme™, a 12 French gauge gastric catheter was
      inserted via the gastric channel.

      Any episode of hypoxemia (SpO2 < 90%), aspiration or regurgitation,bronchospasm and airway
      obstruction were documented. After removal of the LMA, it was examined for the presence of
      visible blood.

      In the postanesthesia care unit, a research assistant, who was blinded to the group
      allocation, interviewed the patients using a predetermined questionnaire to collect data on
      the postoperative pharyngolaryngeal adverse events. The presence or absence of sore throat,
      dysphonia and dysphagia was assessed at 1 and 24 h postoperatively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Double (Investigator, Outcomes Assessor)
measure: First Attempt's Success Rate of Insertion
time frame: after anaesthesia induction
description: Edentulous elderly patients for the success in first attempt insertion, ease and time of insertion (second).
measure: Oropharyngeal Leak Pressure
time frame: before surgery
description: The aim of this study is to compare on the oropharyngeal leak pressure in LMA Unique™ and LMA Supreme™ applications
arm group label: Group LMA Unique
arm group type: Active Comparator
description: The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.The oropharyngeal leak pressure was determined by transiently stopping ventilation and closing the adjustable pressure-limiting valve with a fresh gas flow of 3 L/min until airway pressure reached a steady state and a voice of leakage was heard. The airway pressure was not allowed to exceed 40 cm H2O.
arm group label: Group LMA Supreme
arm group type: Experimental
description: The supraglottic airway devices were deflated fully before insertion. Size 4 LMA was used for those with a weight of 50-70 kg and size 5 LMA for those between 70-100 kg. After insertion, each device was inflated with a hand-held airway manometer (Rusch, Germany) to an intracuff pressure of 60 cm H2O.The oropharyngeal leak pressure was determined by transiently stopping ventilation and closing the adjustable pressure-limiting valve with a fresh gas flow of 3 L/min until airway pressure reached a steady state and a voice of leakage was heard. The airway pressure was not allowed to exceed 40 cm H2O.
intervention type: Device
intervention name: Group LMA Unique™
description: The supraglottic airway devices were deflated fully before insertion. After placement an effective airway was defined as the presence of normal thoracoabdominal movement and a square-wave end-tidal carbon dioxide trace.
arm group label: Group LMA Unique
other name: Laryngeal Mask Airway Unique
other name: LMA Unique (The Laryngeal Mask Company Limited, Singapore)
intervention type: Device
intervention name: Group LMA Supreme™
description: The supraglottic airway devices were deflated fully before insertion.The supraglottic airway devices were deflated fully before insertion. After placement an effective airway was defined as the presence of normal thoracoabdominal movement and a square-wave end-tidal carbon dioxide trace.
arm group label: Group LMA Supreme
other name: Laryngeal Mask Airway Supreme
other name: Teleflex, The Laryngeal Mask Company Limited, Singapore
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: TANGUL KILIÇ, M.D.
role: Principal Investigator
affiliation: Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
last name: SEMİH KUCUKGUCLU, M.D.
role: Study Director
affiliation: Dokuz Eylül University, School of Medicine, Department of Anesthesiology and Reanimation
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Dokuz Eylul University
investigator full name: Sule Ozbilgin
investigator title: Anaesthesiology and Reanimation
mesh term: Mouth, Edentulous
mesh term: Chlorhexidine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 