<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/NCT03028896</url>
  </required_header>
  <id_info>
    <org_study_id>SNU-LMA</org_study_id>
    <nct_id>NCT03028896</nct_id>
  </id_info>
  <brief_title>90° Rotation Technique for LMA FlexibleTM Insertion</brief_title>
  <official_title>Comparison of Standard Versus 90° Rotation Technique for LMA FlexibleTM Insertion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Bundang Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The 90° rotation technique is known to improve the success rate of conventional LMA but its&#xD;
      effect in LMA FlexibleTM is not known. We tried to find if 90° rotation technique could&#xD;
      increase the first attempt success rate of the insertion of LMA FlexibleTM compared to&#xD;
      standard technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One hundred and sixteen adult patients undergoing breast surgery were randomized to the two&#xD;
      insertion techniques. The ease of insertion was assessed by the success rate at the first&#xD;
      attempt. Heart rate and mean blood pressure were recorded 1 min before and 1 min after&#xD;
      insertion. Postoperative complications were checked.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2, 2015</start_date>
  <completion_date type="Actual">January 19, 2017</completion_date>
  <primary_completion_date type="Actual">March 4, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>First Attempt Success Rate</measure>
    <time_frame>at induction</time_frame>
    <description>the first attempt success rate of insertion of LMA FlexibleTM</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insertion Time</measure>
    <time_frame>at induction</time_frame>
    <description>time from passed mouth of the device to the effective ventilation after inflation of the cuff</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oropharyngeal Leak Pressure</measure>
    <time_frame>at induction</time_frame>
    <description>audible leak during manual ventilation at mouth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Blood Staining on the Laryngeal Mask Airway</measure>
    <time_frame>post op 1min</time_frame>
    <description>Number of Participants with blood staining on the laryngeal mask airway.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Laryngeal Masks</condition>
  <arm_group>
    <arm_group_label>standard</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rotational</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>90° rotational technique</intervention_name>
    <description>the LMA FlexibleTM was rotated counter-clockwise through 90°</description>
    <arm_group_label>rotational</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists class I - II&#xD;
&#xD;
          -  Scheduled for elective breast surgery under general anaesthesia using LMA FlexibleTM&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known difficult airway&#xD;
&#xD;
          -  mouth opening less than 2.5 cm&#xD;
&#xD;
          -  limited extension of neck&#xD;
&#xD;
          -  recent sore throat&#xD;
&#xD;
          -  gastroesophageal reflux disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Breast surgery</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Koo BW, Oh AY, Hwang JW, Na HS, Min SW. Comparison of standard versus 90 degrees rotation technique for LMA Flexible insertion: a randomized controlled trial. BMC Anesthesiol. 2019 Jun 7;19(1):95. doi: 10.1186/s12871-019-0773-z.</citation>
    <PMID>31170926</PMID>
  </results_reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <results_first_submitted>January 26, 2018</results_first_submitted>
  <results_first_submitted_qc>January 26, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 26, 2018</results_first_posted>
  <last_update_submitted>February 2, 2022</last_update_submitted>
  <last_update_submitted_qc>February 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>BON WOOK KOO</investigator_full_name>
    <investigator_title>associator professor</investigator_title>
  </responsible_party>
  <keyword>LMA Flexible</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Standard</title>
          <description>In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.</description>
        </group>
        <group group_id="P2">
          <title>Rotational</title>
          <description>After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx.&#xD;
90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard</title>
          <description>In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.</description>
        </group>
        <group group_id="B2">
          <title>Rotational</title>
          <description>After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx.&#xD;
90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°</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="63"/>
            <count group_id="B2" value="66"/>
            <count group_id="B3" value="129"/>
          </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="124"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </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="63"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="129"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>First Attempt Success Rate</title>
        <description>the first attempt success rate of insertion of LMA FlexibleTM</description>
        <time_frame>at induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard</title>
            <description>In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.</description>
          </group>
          <group group_id="O2">
            <title>Rotational</title>
            <description>After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx.&#xD;
90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°</description>
          </group>
        </group_list>
        <measure>
          <title>First Attempt Success Rate</title>
          <description>the first attempt success rate of insertion of LMA FlexibleTM</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="63"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Insertion Time</title>
        <description>time from passed mouth of the device to the effective ventilation after inflation of the cuff</description>
        <time_frame>at induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard</title>
            <description>In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.</description>
          </group>
          <group group_id="O2">
            <title>Rotational</title>
            <description>After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx.&#xD;
90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°</description>
          </group>
        </group_list>
        <measure>
          <title>Insertion Time</title>
          <description>time from passed mouth of the device to the effective ventilation after inflation of the cuff</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="63"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" spread="4.7"/>
                    <measurement group_id="O2" value="9.7" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Oropharyngeal Leak Pressure</title>
        <description>audible leak during manual ventilation at mouth</description>
        <time_frame>at induction</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard</title>
            <description>In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.</description>
          </group>
          <group group_id="O2">
            <title>Rotational</title>
            <description>After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx.&#xD;
90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°</description>
          </group>
        </group_list>
        <measure>
          <title>Oropharyngeal Leak Pressure</title>
          <description>audible leak during manual ventilation at mouth</description>
          <units>cmH2O</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.8" spread="4.9"/>
                    <measurement group_id="O2" value="20.5" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Blood Staining on the Laryngeal Mask Airway</title>
        <description>Number of Participants with blood staining on the laryngeal mask airway.</description>
        <time_frame>post op 1min</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard</title>
            <description>In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.</description>
          </group>
          <group group_id="O2">
            <title>Rotational</title>
            <description>After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx.&#xD;
90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Blood Staining on the Laryngeal Mask Airway</title>
          <description>Number of Participants with blood staining on the laryngeal mask airway.</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="63"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Standard</title>
          <description>In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.</description>
        </group>
        <group group_id="E2">
          <title>Rotational</title>
          <description>After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx.&#xD;
90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90°</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="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="66"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="66"/>
              </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="66"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="66"/>
              </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>Dr. Bon-wook Koo</name_or_title>
      <organization>SNUBH</organization>
      <phone>+82-10-7227-1379 ext 31</phone>
      <email>tendong2@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/NCT03028896
org study id: SNU-LMA
nct id: NCT03028896
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The 90° rotation technique is known to improve the success rate of conventional LMA but its
      effect in LMA FlexibleTM is not known. We tried to find if 90° rotation technique could
      increase the first attempt success rate of the insertion of LMA FlexibleTM compared to
      standard technique.
One hundred and sixteen adult patients undergoing breast surgery were randomized to the two
      insertion techniques. The ease of insertion was assessed by the success rate at the first
      attempt. Heart rate and mean blood pressure were recorded 1 min before and 1 min after
      insertion. Postoperative complications were checked.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: First Attempt Success Rate
time frame: at induction
description: the first attempt success rate of insertion of LMA FlexibleTM
measure: Insertion Time
time frame: at induction
description: time from passed mouth of the device to the effective ventilation after inflation of the cuff
measure: Oropharyngeal Leak Pressure
time frame: at induction
description: audible leak during manual ventilation at mouth
measure: Number of Participants With Blood Staining on the Laryngeal Mask Airway
time frame: post op 1min
description: Number of Participants with blood staining on the laryngeal mask airway.
arm group label: standard
arm group type: No Intervention
description: In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt.
arm group label: rotational
arm group type: Experimental
description: After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx.
intervention type: Procedure
intervention name: 90° rotational technique
description: the LMA FlexibleTM was rotated counter-clockwise through 90°
arm group label: rotational
criteria: 
gender: Female
gender based: Yes
gender description: Breast surgery
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
citation: Koo BW, Oh AY, Hwang JW, Na HS, Min SW. Comparison of standard versus 90 degrees rotation technique for LMA Flexible insertion: a randomized controlled trial. BMC Anesthesiol. 2019 Jun 7;19(1):95. doi: 10.1186/s12871-019-0773-z.
PMID: 31170926
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: BON WOOK KOO
investigator title: associator professor
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 