<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/NCT02189954</url>
  </required_header>
  <id_info>
    <org_study_id>269-GOA</org_study_id>
    <nct_id>NCT02189954</nct_id>
  </id_info>
  <brief_title>Effect of Laryngeal Mask Cuff Pressure in Geriatric Patients</brief_title>
  <official_title>Effect of Laryngeal Mask Cuff Pressure on Postoperative Pharyngolaryngeal Complications in 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>
      Laryngeal Mask is widely used for air-way management during anaesthesia. Pharyngolaryngeal&#xD;
      morbidity linked to laryngeal mask use is related to correct choice of mask size, placement&#xD;
      technique, placement of the laryngeal mask in the correct position on the larynx, cuff volume&#xD;
      and cuff pressure. It has been stated that keeping laryngeal mask cuff pressure below 45 mmHg&#xD;
      (60 centimeter of water(cmH2O) ) can prevent pharyngolaryngeal morbidity related to laryngeal&#xD;
      mask (throat pain, dysphonia, dysphagia) and shown that using a manometer after Laryngeal&#xD;
      Mask Unique placement to limit pressure within the cuff can reduce this morbidity by nearly&#xD;
      70%. Studies commenting on pharyngolaryngeal morbidity generally do not choose a certain age&#xD;
      group and cover stages including very young and middle-aged groups. In the literature only&#xD;
      one similar study on the geriatric age group was found.&#xD;
&#xD;
      The aim of this study is to compare the postoperative pharyngolaryngeal morbidity in a group&#xD;
      with cuff pressure held to 44 mmHg (60 cmH2O with a manometer and a group with Laryngeal Mask&#xD;
      cuff inflated without reference to pressure in the geriatric age group with indications for&#xD;
      Laryngeal Mask Unique placement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study received permission from Dokuz Eylül University Medical Faculty Non-Interventional&#xD;
      Ethics Committee and informed consent was obtained from the patients. Ninety patients above&#xD;
      the age of 65 with American Society of Anesthesiologists (ASA) physiological classification&#xD;
      group I-III, undergoing elective surgery and with indications for laryngeal mask placement&#xD;
      participated in this prospective, randomized and double blind study.&#xD;
&#xD;
      Patients taken to the operating room were given standard monitoring (ECG, pulse oxymetry,&#xD;
      non-invasive blood pressure) and BIS monitoring [BIS-Vista ™ (Aspect Medical Systems, USA)]&#xD;
      before anesthesia induction.&#xD;
&#xD;
      After patients were preoxygenated with 6 L/min oxygen through a face mask for 3 minutes&#xD;
      anesthesia induction was provided by 0.02 mg/kg midazolam, 1-2 µg/kg fentanyl and 1-2 mg/kg&#xD;
      propofol. During respiration Airway was not used, unless there was ventilation difficulty&#xD;
      with the face mask. Before insertion the laryngeal mask used in daily routine (Laryngeal Mask&#xD;
      Unique® (LMU)) was lubricated with a water-based gel and the cuff was completely deflated.&#xD;
      After induction when bispectral index (BIS) values were between 40 and 60 and sufficient chin&#xD;
      relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between&#xD;
      50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with&#xD;
      more than five years experience. The placement method was according to the manufacturer's&#xD;
      instructions. All patients were respirated by a breathing circuit with heat and moisture&#xD;
      filter.&#xD;
&#xD;
      After the laryngeal mask was inserted the cases were manually respirated so peak inspiratory&#xD;
      pressure was less than 20 cmH2O and the cuff of both groups was inflated with a 20 ml&#xD;
      injector until the leak sound ceased. To evaluate ventilation the capnogram showed square&#xD;
      wave forms and the patients' chest movements were observed, in unsuccessful situations the&#xD;
      procedure was repeated. During attempts depending on the patients' reactions and with the&#xD;
      requirement of keeping BIS values between 40 and 60, an additional dose of 0.5 mg/kg propofol&#xD;
      was administered.&#xD;
&#xD;
      After Laryngeal Mask was determined and when anesthetic depth was sufficient (BIS 40-60) the&#xD;
      inner pressure of the LMU cuff was measured and recorded by a manometer (cuff pressure&#xD;
      manometer, Rusch, Germany). Later groups were divided in two using a random number table. In&#xD;
      the group with cuff pressure limitation (Group Pressure Limiting (PL), n=45) cuff inner&#xD;
      pressure was held below 60 cmH2O (44 mmHg), while the routine group (Group Routine Care,&#xD;
      n=45) pressure was only recorded.&#xD;
&#xD;
      Anesthesia was maintained by 50% O2:50% air mix with 1.5-2.5% sevoflurane, with sevoflurane&#xD;
      concentration and additional fentanyl doses arranged to keep BIS between 40 and 60. All&#xD;
      patients were respirated with positive pressure ventilation tidal volume 7-8 ml/kg,&#xD;
      inspiring: expiring rate 1:2, respiration frequency on the capnograph end tidal carbon&#xD;
      dioxide held between 30-35 mmHg. Oropharyngeal leak pressure measurement was recorded as the&#xD;
      pressure value when a leak sound was heard from the mouth after the expiring valve was closed&#xD;
      and fresh gas flow was reduced to 3 L/min. Immediately after the laryngeal mask was inserted,&#xD;
      every 5 minutes in the first half hour and every 15 minutes after that, tidal volume, mean&#xD;
      airway pressure, end tidal carbon dioxide levels and peripheral oxygen saturation values were&#xD;
      recorded. If the operation lasted more than one hour a second manometric measurement was&#xD;
      taken and stable values were maintained.&#xD;
&#xD;
      After the operation, the LMU's were removed when the patients were awake and could open their&#xD;
      mouths on an oral command and unless necessary, aspiration was not applied.After anesthesia&#xD;
      the patients were monitored in the recovery unit and analgesia was provided by 5-10 mg&#xD;
      intravenous dolantin titration. A researcher blind to the groups recorded throat pain, voice&#xD;
      loss and difficulty swallowing in the 1st and 24th hour, classifying as Likert scale ranges&#xD;
      from 1 (none) to 4 (severe). Cases developing rare complications of recurrent laryngeal&#xD;
      nerve, hypoglossal nerve and lingual nerve paralysis were recorded. The cases were brought to&#xD;
      the ward when Aldrete scoring criteria were appropriate. Cases discharged early from the ward&#xD;
      had 24th hour evaluation by telephone communication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour</measure>
    <time_frame>Postoperative 1.hour</time_frame>
    <description>The primary outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 1.hour</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour</measure>
    <time_frame>Postoperative 24.hour</time_frame>
    <description>The primer outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 24.hour</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Anaesthesia</condition>
  <arm_group>
    <arm_group_label>Group Routine Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The placement according to the manufacturer's instructions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Pressure Limiting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cuff inner pressure was held below 44 mmHg</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>The placement according to the manufacturer's instructions</intervention_name>
    <description>Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®(LMU)) 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 five years experience</description>
    <arm_group_label>Group Routine Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cuff inner pressure was held below 44 mmHg</intervention_name>
    <description>cuff pressure limitation (Group Pressure Limiting (PL), n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)</description>
    <arm_group_label>Group Pressure Limiting</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;
          -  Dementia&#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>FERİM GÜNENÇ, M.D.</last_name>
    <role>Principal Investigator</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>
        <zip>35320</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>June 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <results_first_submitted>April 26, 2015</results_first_submitted>
  <results_first_submitted_qc>August 5, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 31, 2015</results_first_posted>
  <last_update_submitted>August 5, 2015</last_update_submitted>
  <last_update_submitted_qc>August 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 31, 2015</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>elderly; laryngeal masks; postoperative complications</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group Routine Care</title>
          <description>The placement according to the manufacturer's instructions.&#xD;
The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique® (LMU) was lubricated with a water-based gel and the cuff was completely deflated. After induction when bispectral index (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 five years experience</description>
        </group>
        <group group_id="P2">
          <title>Group Pressure Limiting</title>
          <description>Cuff inner pressure was held below 44 mmHg&#xD;
Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group Pressure Limiting (PL)), n=45) cuff inner pressure was held below 60 centimeter of water (cmH2O) (44 mmHg)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group Routine Care</title>
          <description>The placement according to the manufacturer's instructions.&#xD;
The placement according to the manufacturer's instructions: 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 five years experience</description>
        </group>
        <group group_id="B2">
          <title>Group Pressure Limiting</title>
          <description>Cuff inner pressure was held below 44 mmHg&#xD;
Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)</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="45"/>
            <count group_id="B2" value="45"/>
            <count group_id="B3" value="90"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.9" spread="5.4"/>
                    <measurement group_id="B2" value="72.8" spread="6.2"/>
                    <measurement group_id="B3" value="72.4" spread="5.8"/>
                  </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="23"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="45"/>
                  </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="45"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour</title>
        <description>The primary outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 1.hour</description>
        <time_frame>Postoperative 1.hour</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group Routine Care</title>
            <description>The placement according to the manufacturer's instructions.&#xD;
The placement according to the manufacturer's instructions: 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 five years experience</description>
          </group>
          <group group_id="O2">
            <title>Group Pressure Limiting</title>
            <description>Cuff inner pressure was held below 44 mmHg&#xD;
Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour</title>
          <description>The primary outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 1.hour</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="1" lower_limit="1" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour</title>
        <description>The primer outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 24.hour</description>
        <time_frame>Postoperative 24.hour</time_frame>
        <population>Chi Square Test for categorical variables, for constant variables t test when suitable for normal distribution and when unsuitable for normal distrubition Mann Whitney U have been used for analysis. p &lt; 0.05 was considered significant.</population>
        <group_list>
          <group group_id="O1">
            <title>Group Routine Care</title>
            <description>The placement according to the manufacturer's instructions.&#xD;
The placement according to the manufacturer's instructions: 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 five years experience</description>
          </group>
          <group group_id="O2">
            <title>Group Pressure Limiting</title>
            <description>Cuff inner pressure was held below 44 mmHg&#xD;
Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour</title>
          <description>The primer outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 24.hour</description>
          <population>Chi Square Test for categorical variables, for constant variables t test when suitable for normal distribution and when unsuitable for normal distrubition Mann Whitney U have been used for analysis. p &lt; 0.05 was considered significant.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="O2" value="1" lower_limit="1" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Mann Whitney U</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Group Routine Care</title>
          <description>The placement according to the manufacturer's instructions.&#xD;
The placement according to the manufacturer's instructions: 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 five years experience</description>
        </group>
        <group group_id="E2">
          <title>Group Pressure Limiting</title>
          <description>Cuff inner pressure was held below 44 mmHg&#xD;
Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)</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="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </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="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="45"/>
              </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>
    <limitations_and_caveats>Limitations of our study include the lack of imaging with a fiberoptic bronchoscope after LMU placement and not evaluating the position in the hypopharynx of the supraglottic airway device in the geriatric age group.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Anaesthesiology and Reanimation, Dr. Sule Ozbilgin</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/NCT02189954
org study id: 269-GOA
nct id: NCT02189954
lead sponsor: 
has dmc: No
Laryngeal Mask is widely used for air-way management during anaesthesia. Pharyngolaryngeal
      morbidity linked to laryngeal mask use is related to correct choice of mask size, placement
      technique, placement of the laryngeal mask in the correct position on the larynx, cuff volume
      and cuff pressure. It has been stated that keeping laryngeal mask cuff pressure below 45 mmHg
      (60 centimeter of water(cmH2O) ) can prevent pharyngolaryngeal morbidity related to laryngeal
      mask (throat pain, dysphonia, dysphagia) and shown that using a manometer after Laryngeal
      Mask Unique placement to limit pressure within the cuff can reduce this morbidity by nearly
      70%. Studies commenting on pharyngolaryngeal morbidity generally do not choose a certain age
      group and cover stages including very young and middle-aged groups. In the literature only
      one similar study on the geriatric age group was found.

      The aim of this study is to compare the postoperative pharyngolaryngeal morbidity in a group
      with cuff pressure held to 44 mmHg (60 cmH2O with a manometer and a group with Laryngeal Mask
      cuff inflated without reference to pressure in the geriatric age group with indications for
      Laryngeal Mask Unique placement.
This study received permission from Dokuz Eylül University Medical Faculty Non-Interventional
      Ethics Committee and informed consent was obtained from the patients. Ninety 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, randomized and double blind study.

      Patients taken to the operating room were given standard monitoring (ECG, pulse oxymetry,
      non-invasive blood pressure) and BIS monitoring [BIS-Vista ™ (Aspect Medical Systems, USA)]
      before anesthesia induction.

      After patients were preoxygenated with 6 L/min oxygen through a face mask for 3 minutes
      anesthesia induction was provided by 0.02 mg/kg midazolam, 1-2 µg/kg fentanyl and 1-2 mg/kg
      propofol. During respiration Airway was not used, unless there was ventilation difficulty
      with the face mask. Before insertion the laryngeal mask used in daily routine (Laryngeal Mask
      Unique® (LMU)) was lubricated with a water-based gel and the cuff was completely deflated.
      After induction when bispectral index (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 five years experience. The placement method was according to the manufacturer's
      instructions. All patients were respirated by a breathing circuit with heat and moisture
      filter.

      After the laryngeal mask was inserted the cases were manually respirated so peak inspiratory
      pressure was less than 20 cmH2O and the cuff of both groups was inflated with a 20 ml
      injector until the leak sound ceased. To evaluate ventilation the capnogram showed square
      wave forms and the patients' chest movements were observed, in unsuccessful situations the
      procedure was repeated. During attempts depending on the patients' reactions and with the
      requirement of keeping BIS values between 40 and 60, an additional dose of 0.5 mg/kg propofol
      was administered.

      After Laryngeal Mask was determined and when anesthetic depth was sufficient (BIS 40-60) the
      inner pressure of the LMU cuff was measured and recorded by a manometer (cuff pressure
      manometer, Rusch, Germany). Later groups were divided in two using a random number table. In
      the group with cuff pressure limitation (Group Pressure Limiting (PL), n=45) cuff inner
      pressure was held below 60 cmH2O (44 mmHg), while the routine group (Group Routine Care,
      n=45) pressure was only recorded.

      Anesthesia was maintained by 50% O2:50% air mix with 1.5-2.5% sevoflurane, with sevoflurane
      concentration and additional fentanyl doses arranged to keep BIS between 40 and 60. All
      patients were respirated with positive pressure ventilation tidal volume 7-8 ml/kg,
      inspiring: expiring rate 1:2, respiration frequency on the capnograph end tidal carbon
      dioxide held between 30-35 mmHg. Oropharyngeal leak pressure measurement was recorded as the
      pressure value when a leak sound was heard from the mouth after the expiring valve was closed
      and fresh gas flow was reduced to 3 L/min. Immediately after the laryngeal mask was inserted,
      every 5 minutes in the first half hour and every 15 minutes after that, tidal volume, mean
      airway pressure, end tidal carbon dioxide levels and peripheral oxygen saturation values were
      recorded. If the operation lasted more than one hour a second manometric measurement was
      taken and stable values were maintained.

      After the operation, the LMU's were removed when the patients were awake and could open their
      mouths on an oral command and unless necessary, aspiration was not applied.After anesthesia
      the patients were monitored in the recovery unit and analgesia was provided by 5-10 mg
      intravenous dolantin titration. A researcher blind to the groups recorded throat pain, voice
      loss and difficulty swallowing in the 1st and 24th hour, classifying as Likert scale ranges
      from 1 (none) to 4 (severe). Cases developing rare complications of recurrent laryngeal
      nerve, hypoglossal nerve and lingual nerve paralysis were recorded. The cases were brought to
      the ward when Aldrete scoring criteria were appropriate. Cases discharged early from the ward
      had 24th hour evaluation by telephone communication.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Double (Investigator, Outcomes Assessor)
measure: Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour
time frame: Postoperative 1.hour
description: The primary outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 1.hour
measure: Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour
time frame: Postoperative 24.hour
description: The primer outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 24.hour
arm group label: Group Routine Care
arm group type: Active Comparator
description: The placement according to the manufacturer's instructions.
arm group label: Group Pressure Limiting
arm group type: Experimental
description: Cuff inner pressure was held below 44 mmHg
intervention type: Procedure
intervention name: The placement according to the manufacturer's instructions
description: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®(LMU)) 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 five years experience
arm group label: Group Routine Care
intervention type: Procedure
intervention name: Cuff inner pressure was held below 44 mmHg
description: cuff pressure limitation (Group Pressure Limiting (PL), n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)
arm group label: Group Pressure Limiting
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: FERİM GÜNENÇ, M.D.
role: Principal Investigator
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: 
limitations and caveats: Limitations of our study include the lack of imaging with a fiberoptic bronchoscope after LMU placement and not evaluating the position in the hypopharynx of the supraglottic airway device in the geriatric age group.
point of contact: 