<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/NCT02257411</url>
  </required_header>
  <id_info>
    <org_study_id>346</org_study_id>
    <nct_id>NCT02257411</nct_id>
  </id_info>
  <brief_title>A Method to Determine the Size of Laryngeal Mask Airway (LMA)</brief_title>
  <official_title>A Simple Method to Determine the Size of the ProSeal LMA (PLMA) in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yeditepe University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yeditepe University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      After institutional ethics board approval and written informed consent from parents, 197&#xD;
      children scheduled for routine genitourinary operation and in whom a LMA was indicated for&#xD;
      anesthesia were included in the study. The size of the LMA was determined by choosing the&#xD;
      size that was best matched with the auricle of the children. The results were compared with&#xD;
      the standard method recommended by the manufacturer's weight-related guidelines. The patients&#xD;
      were classified in different groups depending on the PLMA sizes determined by both methods. A&#xD;
      kappa coefficient evaluated the agreement between both techniques.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the sizes of the PLMA determined with the ear-based formula</measure>
    <time_frame>One year</time_frame>
    <description>we were to determine whether the size of the auricle could be used as a proxy for the appropriate size of the PLMA</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">197</enrollment>
  <condition>Ear Based ProSeal LMA</condition>
  <arm_group>
    <arm_group_label>Ear-sized based and weight based formula</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the sizes of the PLMA determined with the ear-based compared with the sizes according to the manufacturer's weight-based formula</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ear-sized based</intervention_name>
    <description>the sizes of the PLMA determined with the ear-based formula were compared with the sizes according to the manufacturer's weight-based formula</description>
    <arm_group_label>Ear-sized based and weight based formula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA physical status I/II&#xD;
&#xD;
          -  scheduled for genitourinary operation&#xD;
&#xD;
          -  LMA was indicated for anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  surgery lasting more than 3 h&#xD;
&#xD;
          -  overweight or underweight patients&#xD;
&#xD;
          -  gastroesophageal reflux&#xD;
&#xD;
          -  risk of aspiration&#xD;
&#xD;
          -  airway infection in the last six weeks&#xD;
&#xD;
          -  decreased pulmonary or chest wall compliance.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yeditepe University Hospital</name>
      <address>
        <city>İstanbul</city>
        <state>Kozyatağı</state>
        <zip>34752</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>October 1, 2014</last_update_submitted>
  <last_update_submitted_qc>October 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yeditepe University Hospital</investigator_affiliation>
    <investigator_full_name>Murat Haliloglu</investigator_full_name>
    <investigator_title>Medical doctor</investigator_title>
  </responsible_party>
  <keyword>child</keyword>
  <keyword>ear based</keyword>
  <keyword>Proseal LMA</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02257411
org study id: 346
nct id: NCT02257411
lead sponsor: 
has dmc: No
After institutional ethics board approval and written informed consent from parents, 197
      children scheduled for routine genitourinary operation and in whom a LMA was indicated for
      anesthesia were included in the study. The size of the LMA was determined by choosing the
      size that was best matched with the auricle of the children. The results were compared with
      the standard method recommended by the manufacturer's weight-related guidelines. The patients
      were classified in different groups depending on the PLMA sizes determined by both methods. A
      kappa coefficient evaluated the agreement between both techniques.
allocation: N/A
intervention model: Single Group Assignment
masking: Triple (Participant, Care Provider, Investigator)
measure: the sizes of the PLMA determined with the ear-based formula
time frame: One year
description: we were to determine whether the size of the auricle could be used as a proxy for the appropriate size of the PLMA
arm group label: Ear-sized based and weight based formula
arm group type: Active Comparator
description: the sizes of the PLMA determined with the ear-based compared with the sizes according to the manufacturer's weight-based formula
intervention type: Device
intervention name: Ear-sized based
description: the sizes of the PLMA determined with the ear-based formula were compared with the sizes according to the manufacturer's weight-based formula
arm group label: Ear-sized based and weight based formula
criteria: 
gender: All
minimum age: N/A
maximum age: 15 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Yeditepe University Hospital
investigator full name: Murat Haliloglu
investigator title: Medical doctor