<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/NCT02219282</url>
  </required_header>
  <id_info>
    <org_study_id>2010/08-15</org_study_id>
    <nct_id>NCT02219282</nct_id>
  </id_info>
  <brief_title>Geriatric Patients and Laryngeal Mask Unique</brief_title>
  <official_title>A Comparison of Laryngeal Mask UniqueTM in Denticulate and Edentulate 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>
      As a result of rises in living standards quality of life is progressively increasing.&#xD;
      Combined with developments in anesthesia, surgical techniques and medication allowing more&#xD;
      difficult and complicated interventions to be carried out, elderly patients are encountered&#xD;
      more often in daily anesthetic practice.Reduced tone in the upper airway of geriatric&#xD;
      patients increases the possibility of airway obstruction. In old patients with no teeth,&#xD;
      sunken cheeks may make ventilation with a mask ineffective; perhaps even impossible.&#xD;
&#xD;
      In addition to our observations that Laryngeal mask (LM) is more difficult to place in older&#xD;
      patients, in the literature there are very few studies on the use of LM in older patients.&#xD;
      Sixty percent of patients over the age of 65 have no teeth. Ventilation with a mask is more&#xD;
      difficult for patients without teeth compared to those with teeth. Laryngeal mask is an&#xD;
      alternative airway device for patients without teeth when the face mask does not sit&#xD;
      correctly.&#xD;
&#xD;
      The aim of this study is primarily to measure the success of placement on first try, ease and&#xD;
      duration of insertion and oropharyngeal leak pressure of laryngeal mask Unique (LMU) in&#xD;
      patients 65 years of age and above dentulous and edentulous elderly patients. The secondary&#xD;
      aim is to compare the effects on the hemodynamic response occurring during placement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study received permission from Dokuz Eylül University Medical Faculty Ethics Committee&#xD;
      and informed consent was obtained from the patients. Sixty-six patients above the age of 65&#xD;
      with American Society of Anesthesiologists (ASA) physiological classification group I-III,&#xD;
      undergoing elective surgery and with indications for laryngeal mask placement participated in&#xD;
      this prospective, and double bland study.&#xD;
&#xD;
      Patients taken to the operating room were monitored for heart rate (HR), systolic blood&#xD;
      pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP),&#xD;
      electrocardiography (ECG-Derivation II), and peripheral oxygen saturation (SpO2) before&#xD;
      anesthesia induction. Depth of anesthesia was evaluated with a bispectral index monitor. The&#xD;
      patients were preoxygenated with 6 L.min-1 oxygen through a face mask for 3 minutes. For&#xD;
      anesthesia induction 0.02 mg.kg-1 midazolam, 1-2 μg.kg-1 fentanyl and 1-2 mg.kg-1 propofol&#xD;
      were used. Afterwards patients were given mask ventilation with 100% oxygen. Before laryngeal&#xD;
      masks were inserted they were prepared by being lubricated with water-based gel and the cuffs&#xD;
      were completely deflated.&#xD;
&#xD;
      After induction agents were administered when BIS values were between 40-60 and sufficient&#xD;
      chin relaxation was obtained LMU was inserted according to the standard methods determined by&#xD;
      Brain. The LMU size was chosen based on the patient's body weight; those from 30-50 kg used&#xD;
      no. 3, from 50-70 kg used no. 4 and those from 70-100 kg used no 5 LMU. During attempts&#xD;
      depending on the patient reaction and to keep the BIS values 40-60, an additional dose of 0.5&#xD;
      mg/kg propofol was administered.&#xD;
&#xD;
      The cuffs of the laryngeal mask were inflated and held at 60 centimeters of water. After the&#xD;
      operation before the LM was removed the cuff inner pressure was measured again and recorded.&#xD;
      The success of the first attempt at insertion of the laryngeal mask was recorded. During&#xD;
      placement in cases with 3 unsuccessful attempts, patients were intubated to provide airway&#xD;
      management.&#xD;
&#xD;
      Anesthesia was maintained with a 50% O2/air mix with 1.5-2.5% sevoflurane. Concentration of&#xD;
      sevoflurane was set to keep the bispectral index value below 40.&#xD;
&#xD;
      Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure&#xD;
      (MAP), heart rate (HR) and bispectral index values (BIS) were recorded before anesthesia&#xD;
      induction, before LM insertion and in the 1st, 2nd, 3rd and 5th minutes after LM insertion&#xD;
      was confirmed.&#xD;
&#xD;
      The time for successful insertion was defined as the duration from mouth opening to first&#xD;
      successful ventilation and recorded. The number of insertion attempts and ease of insertion&#xD;
      were recorded.&#xD;
&#xD;
      Criteria indicating successful laryngeal mask placement:&#xD;
&#xD;
        1. Waves with square shape on capnogram&#xD;
&#xD;
        2. Easy ventilation with respiration balloon and observed chest movement&#xD;
&#xD;
        3. No ventilation leak with approximately 20 centimeters of water positive pressure&#xD;
           Evaluation of ease of insertion based on likert scala (1-4 point from easy to&#xD;
           unsuccessful).&#xD;
&#xD;
      After laryngeal mask insertion, the oropharyngeal leak test was conducted by a researcher&#xD;
      unaware of whether the patients had teeth or not. To complete the test after the expiring&#xD;
      valve was shut fresh gas flow was reduced to 3 L.min-1. When the sound of a leak was heard&#xD;
      from the mouth the airway pressure value (OLP) was recorded. During this test airway pressure&#xD;
      was not allowed to rise above 40 centimeters of water. From the start of the operation to the&#xD;
      end, the patients were monitored for hypoxia (SpO2 falling below 90%) and laryngospasm. In&#xD;
      cases where the third attempt at LM insertion was unsuccessful, if the SpO2 values fell below&#xD;
      90% at any time in the study or if laryngospasm developed, the patients were excluded from&#xD;
      the study.&#xD;
&#xD;
      The duration of use of laryngeal mask (duration from insertion to removal) in both groups&#xD;
      were recorded. After the laryngeal mask was removed it was evaluated for traces of blood.&#xD;
      When leaving the recovery unit and 24 hours later throat pain, dysphonia and dysphagia were&#xD;
      evaluated. Throat pain was evaluated using the VAS-10 (visual analogue scale).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">December 2010</completion_date>
  <primary_completion_date type="Actual">November 2010</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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>Number of Participants With Successful Laryngeal Mask Placement</measure>
    <time_frame>Baseline</time_frame>
    <description>The aim of this study is primarily to measure the success of placement on first try in dentulous and edentulous elderly patients for success of placement on first try.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oropharyngeal Leak Pressure</measure>
    <time_frame>Baseline</time_frame>
    <description>Oropharyngeal leak pressure (cm H20) in dentulous and edentulous elderly patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemodynamic Response to Insertion of Airway Device.</measure>
    <time_frame>Before anesthesia induction, before laryngeal mask insertion and in the 1st, 2nd, 3rd and 5th minutes after laryngeal mask insertion</time_frame>
    <description>Mean blood pressure (MBP) (mmHg) were recorded in both groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of Placement Laryngeal Mask</measure>
    <time_frame>During Laryngeal mask placement</time_frame>
    <description>Ease (according to Likert scale 1-4 point from easy to diffucult).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insertion Time of Laryngeal Mask</measure>
    <time_frame>During placement of Laryngeal Mask</time_frame>
    <description>Duration of insertion (second) Laryngeal Mask;second</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Anaesthesia</condition>
  <arm_group>
    <arm_group_label>Group Dentulous</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laryngeal Mask Unique insertion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Edentulous</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laryngeal Mask Unique insertion</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laryngeal Mask Unique insertion</intervention_name>
    <description>Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.</description>
    <arm_group_label>Group Dentulous</arm_group_label>
    <arm_group_label>Group Edentulous</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Above the age of 65&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
          -  Undergoing elective surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with recent history of upper respiratory infection&#xD;
&#xD;
          -  Obese patients with body-mass index above 35 kg/m2&#xD;
&#xD;
          -  Symptomatic hiatus hernia&#xD;
&#xD;
          -  Severe gastroesophageal reflux&#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>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>May 2017</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <results_first_submitted>April 26, 2015</results_first_submitted>
  <results_first_submitted_qc>May 25, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 29, 2017</results_first_posted>
  <last_update_submitted>May 25, 2017</last_update_submitted>
  <last_update_submitted_qc>May 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2017</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, edentulate geriatric patients</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group Dentulous</title>
          <description>Laryngeal Mask Unique insertion&#xD;
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.</description>
        </group>
        <group group_id="P2">
          <title>Group Edentulous</title>
          <description>Laryngeal Mask Unique insertion&#xD;
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group Dentulous</title>
          <description>Laryngeal Mask Unique insertion&#xD;
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.</description>
        </group>
        <group group_id="B2">
          <title>Group Edentulous</title>
          <description>Laryngeal Mask Unique insertion&#xD;
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.</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="33"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="66"/>
          </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="33"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="66"/>
                  </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="22"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Turkey</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Successful Laryngeal Mask Placement</title>
        <description>The aim of this study is primarily to measure the success of placement on first try in dentulous and edentulous elderly patients for success of placement on first try.</description>
        <time_frame>Baseline</time_frame>
        <population>For one patient in each group, dentulous and edentulous, insertion of the LMU was unsuccessful on the third attempt, and these patients were intubated; therefore, these two patients were excluded from the study and were not included in the statistical analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Group Dentulous</title>
            <description>Laryngeal Mask Unique insertion&#xD;
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.</description>
          </group>
          <group group_id="O2">
            <title>Group Edentulous</title>
            <description>Laryngeal Mask Unique insertion&#xD;
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Successful Laryngeal Mask Placement</title>
          <description>The aim of this study is primarily to measure the success of placement on first try in dentulous and edentulous elderly patients for success of placement on first try.</description>
          <population>For one patient in each group, dentulous and edentulous, insertion of the LMU was unsuccessful on the third attempt, and these patients were intubated; therefore, these two patients were excluded from the study and were not included in the statistical analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>First Attempt</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Second Attempt</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Third attempt</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oropharyngeal Leak Pressure</title>
        <description>Oropharyngeal leak pressure (cm H20) in dentulous and edentulous elderly patients.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group Dentulous</title>
            <description>Laryngeal Mask Unique insertion&#xD;
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.</description>
          </group>
          <group group_id="O2">
            <title>Group Edentulous</title>
            <description>Laryngeal Mask Unique insertion&#xD;
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.</description>
          </group>
        </group_list>
        <measure>
          <title>Oropharyngeal Leak Pressure</title>
          <description>Oropharyngeal leak pressure (cm H20) in dentulous and edentulous elderly patients.</description>
          <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="32"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.75" spread="4.62"/>
                    <measurement group_id="O2" value="20.75" spread="5.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Haemodynamic Response to Insertion of Airway Device.</title>
        <description>Mean blood pressure (MBP) (mmHg) were recorded in both groups.</description>
        <time_frame>Before anesthesia induction, before laryngeal mask insertion and in the 1st, 2nd, 3rd and 5th minutes after laryngeal mask insertion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group Dentulous</title>
            <description>Laryngeal Mask Unique insertion&#xD;
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.</description>
          </group>
          <group group_id="O2">
            <title>Group Edentulous</title>
            <description>Laryngeal Mask Unique insertion&#xD;
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.</description>
          </group>
        </group_list>
        <measure>
          <title>Haemodynamic Response to Insertion of Airway Device.</title>
          <description>Mean blood pressure (MBP) (mmHg) were recorded in both groups.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Before anesthesia induction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.3" spread="10"/>
                    <measurement group_id="O2" value="95.1" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>before laryngeal mask insertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.1" spread="8"/>
                    <measurement group_id="O2" value="80.2" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 minutes after laryngeal mask insertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.1" spread="5"/>
                    <measurement group_id="O2" value="79.2" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 minutes after laryngeal mask insertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.2" spread="8"/>
                    <measurement group_id="O2" value="73.1" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 minutes after laryngeal mask insertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.2" spread="7"/>
                    <measurement group_id="O2" value="70.3" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 minutes after laryngeal mask insertion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.4" spread="7"/>
                    <measurement group_id="O2" value="72.6" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ease of Placement Laryngeal Mask</title>
        <description>Ease (according to Likert scale 1-4 point from easy to diffucult).</description>
        <time_frame>During Laryngeal mask placement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dentulous</title>
            <description>Laryngeal Mask Unique insertion&#xD;
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience</description>
          </group>
          <group group_id="O2">
            <title>Edentuolus</title>
            <description>Laryngeal Mask Unique insertion&#xD;
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience</description>
          </group>
        </group_list>
        <measure>
          <title>Ease of Placement Laryngeal Mask</title>
          <description>Ease (according to Likert scale 1-4 point from easy to diffucult).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Insertion Time of Laryngeal Mask</title>
        <description>Duration of insertion (second) Laryngeal Mask;second</description>
        <time_frame>During placement of Laryngeal Mask</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dentilous Group</title>
            <description>Laryngeal Mask Unique insertion&#xD;
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience</description>
          </group>
          <group group_id="O2">
            <title>Edentulous Group</title>
            <description>Laryngeal Mask Unique insertion&#xD;
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience</description>
          </group>
        </group_list>
        <measure>
          <title>Insertion Time of Laryngeal Mask</title>
          <description>Duration of insertion (second) Laryngeal Mask;second</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.40" spread="4.80"/>
                    <measurement group_id="O2" value="13.43" spread="4.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Group Dentulous</title>
          <description>Laryngeal Mask Unique insertion&#xD;
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.</description>
        </group>
        <group group_id="E2">
          <title>Group Edentulous</title>
          <description>Laryngeal Mask Unique insertion&#xD;
Laryngeal Mask Unique insertion: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </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="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </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>Semih Kucukguclu</name_or_title>
      <organization>DorkuzEU</organization>
      <phone>902324125707</phone>
      <email>semih.kucukguclu@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/NCT02219282
org study id: 2010/08-15
nct id: NCT02219282
lead sponsor: 
has dmc: No
As a result of rises in living standards quality of life is progressively increasing.
      Combined with developments in anesthesia, surgical techniques and medication allowing more
      difficult and complicated interventions to be carried out, elderly patients are encountered
      more often in daily anesthetic practice.Reduced tone in the upper airway of geriatric
      patients increases the possibility of airway obstruction. In old patients with no teeth,
      sunken cheeks may make ventilation with a mask ineffective; perhaps even impossible.

      In addition to our observations that Laryngeal mask (LM) is more difficult to place in older
      patients, in the literature there are very few studies on the use of LM in older patients.
      Sixty percent of patients over the age of 65 have no teeth. Ventilation with a mask is more
      difficult for patients without teeth compared to those with teeth. Laryngeal mask is an
      alternative airway device for patients without teeth when the face mask does not sit
      correctly.

      The aim of this study is primarily to measure the success of placement on first try, ease and
      duration of insertion and oropharyngeal leak pressure of laryngeal mask Unique (LMU) in
      patients 65 years of age and above dentulous and edentulous elderly patients. The secondary
      aim is to compare the effects on the hemodynamic response occurring during placement.
This study received permission from Dokuz Eylül University Medical Faculty Ethics Committee
      and informed consent was obtained from the patients. Sixty-six patients above the age of 65
      with American Society of Anesthesiologists (ASA) physiological classification group I-III,
      undergoing elective surgery and with indications for laryngeal mask placement participated in
      this prospective, and double bland study.

      Patients taken to the operating room were monitored for heart rate (HR), systolic blood
      pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP),
      electrocardiography (ECG-Derivation II), and peripheral oxygen saturation (SpO2) before
      anesthesia induction. Depth of anesthesia was evaluated with a bispectral index monitor. The
      patients were preoxygenated with 6 L.min-1 oxygen through a face mask for 3 minutes. For
      anesthesia induction 0.02 mg.kg-1 midazolam, 1-2 μg.kg-1 fentanyl and 1-2 mg.kg-1 propofol
      were used. Afterwards patients were given mask ventilation with 100% oxygen. Before laryngeal
      masks were inserted they were prepared by being lubricated with water-based gel and the cuffs
      were completely deflated.

      After induction agents were administered when BIS values were between 40-60 and sufficient
      chin relaxation was obtained LMU was inserted according to the standard methods determined by
      Brain. The LMU size was chosen based on the patient's body weight; those from 30-50 kg used
      no. 3, from 50-70 kg used no. 4 and those from 70-100 kg used no 5 LMU. During attempts
      depending on the patient reaction and to keep the BIS values 40-60, an additional dose of 0.5
      mg/kg propofol was administered.

      The cuffs of the laryngeal mask were inflated and held at 60 centimeters of water. After the
      operation before the LM was removed the cuff inner pressure was measured again and recorded.
      The success of the first attempt at insertion of the laryngeal mask was recorded. During
      placement in cases with 3 unsuccessful attempts, patients were intubated to provide airway
      management.

      Anesthesia was maintained with a 50% O2/air mix with 1.5-2.5% sevoflurane. Concentration of
      sevoflurane was set to keep the bispectral index value below 40.

      Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure
      (MAP), heart rate (HR) and bispectral index values (BIS) were recorded before anesthesia
      induction, before LM insertion and in the 1st, 2nd, 3rd and 5th minutes after LM insertion
      was confirmed.

      The time for successful insertion was defined as the duration from mouth opening to first
      successful ventilation and recorded. The number of insertion attempts and ease of insertion
      were recorded.

      Criteria indicating successful laryngeal mask placement:

        1. Waves with square shape on capnogram

        2. Easy ventilation with respiration balloon and observed chest movement

        3. No ventilation leak with approximately 20 centimeters of water positive pressure
           Evaluation of ease of insertion based on likert scala (1-4 point from easy to
           unsuccessful).

      After laryngeal mask insertion, the oropharyngeal leak test was conducted by a researcher
      unaware of whether the patients had teeth or not. To complete the test after the expiring
      valve was shut fresh gas flow was reduced to 3 L.min-1. When the sound of a leak was heard
      from the mouth the airway pressure value (OLP) was recorded. During this test airway pressure
      was not allowed to rise above 40 centimeters of water. From the start of the operation to the
      end, the patients were monitored for hypoxia (SpO2 falling below 90%) and laryngospasm. In
      cases where the third attempt at LM insertion was unsuccessful, if the SpO2 values fell below
      90% at any time in the study or if laryngospasm developed, the patients were excluded from
      the study.

      The duration of use of laryngeal mask (duration from insertion to removal) in both groups
      were recorded. After the laryngeal mask was removed it was evaluated for traces of blood.
      When leaving the recovery unit and 24 hours later throat pain, dysphonia and dysphagia were
      evaluated. Throat pain was evaluated using the VAS-10 (visual analogue scale).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Double (Investigator, Outcomes Assessor)
measure: Number of Participants With Successful Laryngeal Mask Placement
time frame: Baseline
description: The aim of this study is primarily to measure the success of placement on first try in dentulous and edentulous elderly patients for success of placement on first try.
measure: Oropharyngeal Leak Pressure
time frame: Baseline
description: Oropharyngeal leak pressure (cm H20) in dentulous and edentulous elderly patients.
measure: Haemodynamic Response to Insertion of Airway Device.
time frame: Before anesthesia induction, before laryngeal mask insertion and in the 1st, 2nd, 3rd and 5th minutes after laryngeal mask insertion
description: Mean blood pressure (MBP) (mmHg) were recorded in both groups.
measure: Ease of Placement Laryngeal Mask
time frame: During Laryngeal mask placement
description: Ease (according to Likert scale 1-4 point from easy to diffucult).
measure: Insertion Time of Laryngeal Mask
time frame: During placement of Laryngeal Mask
description: Duration of insertion (second) Laryngeal Mask;second
arm group label: Group Dentulous
arm group type: Active Comparator
description: Laryngeal Mask Unique insertion
arm group label: Group Edentulous
arm group type: Experimental
description: Laryngeal Mask Unique insertion
intervention type: Other
intervention name: Laryngeal Mask Unique insertion
description: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
arm group label: Group Dentulous
arm group label: Group Edentulous
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
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
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 