<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/NCT02220075</url>
  </required_header>
  <id_info>
    <org_study_id>4-2013-0550</org_study_id>
    <nct_id>NCT02220075</nct_id>
  </id_info>
  <brief_title>Fiberoptic Evaluation of the LMA(Laryngel Mask Airway) Position During Anesthesia With Spontaneous Respiration or Controlled Ventilation in Children</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      LMA(Laryngel Mask Airway) is useful for pediatrics surgery, and there are various methods of&#xD;
      LMA insertion. When the investigators evaluate the LMA position, the investigators can use&#xD;
      fiberoptic bronchoscope (Grade 1 to 4). For pediatric patients, clinical signs(airway&#xD;
      pressure&lt;20cmH2O, expiratory CO2 level)are seen normal but the grade is 3 or 4. And this will&#xD;
      bring high risk of aspiration. Recent studies reported the LMA position after general&#xD;
      anesthesia induction not after operation. Therefore, the investigators will observe the LMA&#xD;
      position three times; after general anesthesia induction, after caudal block, and after&#xD;
      operation as well as the difference regarding to spontaneous and controlled ventilation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 4, 2015</start_date>
  <completion_date type="Actual">April 3, 2015</completion_date>
  <primary_completion_date type="Actual">April 3, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>sucess rate of LMA insertion</measure>
    <time_frame>1 hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>FOB(fiberoptic bronchoscope) grading of LMA position</measure>
    <time_frame>1 hour</time_frame>
    <description>Grade 1: only the larynx visible, Grade 2: larynz and epiglottis visible, Grade 3: epiglottis was impinging on the LMA grille, Grade 4: epiglottis was downfolded and the larynx could not be seen)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Pediatric Urologic Surgery</condition>
  <arm_group>
    <arm_group_label>spontaneous group</arm_group_label>
    <description>maintain spontaneous breathing during the operation, and recording tidal volume, ET CO2, respiratory rate, peak airway pressure, SpO2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controlled group</arm_group_label>
    <description>controlled ventilation(tidal volume 8ml/kg, ET CO2 35~40mmHg) during the operation, recording peak airway pressure, SpO2</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric patients who are planed to get urologic surgery under general anesthesia using&#xD;
        LMA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ASA physical status 1 or 2,&#xD;
&#xD;
          2. pediatric patients from 1month to 7 years old&#xD;
&#xD;
          3. under general anesthesia using LMA&#xD;
&#xD;
          4. getting informed consent from the guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. difficult airway&#xD;
&#xD;
          2. airway diseases ; URI, asthma, pneumonia&#xD;
&#xD;
          3. not getting informed consent from the guardian&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>March 25, 2019</last_update_submitted>
  <last_update_submitted_qc>March 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fiberoptic, LMA, caudal block</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/NCT02220075
org study id: 4-2013-0550
nct id: NCT02220075
lead sponsor: 
has dmc: No
LMA(Laryngel Mask Airway) is useful for pediatrics surgery, and there are various methods of
      LMA insertion. When the investigators evaluate the LMA position, the investigators can use
      fiberoptic bronchoscope (Grade 1 to 4). For pediatric patients, clinical signs(airway
      pressure<20cmH2O, expiratory CO2 level)are seen normal but the grade is 3 or 4. And this will
      bring high risk of aspiration. Recent studies reported the LMA position after general
      anesthesia induction not after operation. Therefore, the investigators will observe the LMA
      position three times; after general anesthesia induction, after caudal block, and after
      operation as well as the difference regarding to spontaneous and controlled ventilation.
observational model: Other
time perspective: Prospective
measure: sucess rate of LMA insertion
time frame: 1 hour
measure: FOB(fiberoptic bronchoscope) grading of LMA position
time frame: 1 hour
description: Grade 1: only the larynx visible, Grade 2: larynz and epiglottis visible, Grade 3: epiglottis was impinging on the LMA grille, Grade 4: epiglottis was downfolded and the larynx could not be seen)
arm group label: spontaneous group
description: maintain spontaneous breathing during the operation, and recording tidal volume, ET CO2, respiratory rate, peak airway pressure, SpO2
arm group label: controlled group
description: controlled ventilation(tidal volume 8ml/kg, ET CO2 35~40mmHg) during the operation, recording peak airway pressure, SpO2
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 7 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor