<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/NCT04494802</url>
  </required_header>
  <id_info>
    <org_study_id>Gastric insufflation</org_study_id>
    <nct_id>NCT04494802</nct_id>
  </id_info>
  <brief_title>The Influence of LMA Cuff Pressure on Gastric Insufflation Assessed by Ultrasound in Pediatric Patient</brief_title>
  <official_title>The Influence of LMA Cuff Pressure on Oropharyngeal Leak Pressure and Gastric Insufflation Assessed by Ultrasound in Pediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cuff inflation up to the maximum cuff pressure when using LMA flexible can cause sore throat&#xD;
      and discomfort after the surgery, and if the surgery is unexpectedly prolonged, there can be&#xD;
      a side effect that can cause ischemic damage around the neck. If keeping cuff pressure low&#xD;
      will not increase gastric insufflation and there is no change in other outcome variables,&#xD;
      keeping it low may have a positive effect on anesthesia management and outcome in children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 10, 2020</start_date>
  <completion_date type="Anticipated">August 10, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 10, 2021</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of gastric insufflation(antrum)</measure>
    <time_frame>During the surgery(up to 3 hours)</time_frame>
    <description>Incidence of gastric insufflation which was recognized in gastric antrum with ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The size of gastric antrum and body</measure>
    <time_frame>During the surgery(up to 3 hours)</time_frame>
    <description>The size of gastric antrum and body assessed immediately after insertion of LMA flexible and after finishing the surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for insertion of LMA flexible</measure>
    <time_frame>During the anesthesia induction(up to 1 hour)</time_frame>
    <description>Time for insertion of LMA flexible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success rate of insertion of LMA flexible</measure>
    <time_frame>During the anesthesia induction(up to 1 hour)</time_frame>
    <description>Success rate of insertion of LMA flexible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of insertion attempt</measure>
    <time_frame>During the anesthesia induction(up to 1 hour)</time_frame>
    <description>The number of insertion attempt</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number and the type of additional manipulation for successful ventilation</measure>
    <time_frame>During the surgery(up to 3 hours)</time_frame>
    <description>The number and the type of additional manipulation for successful ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of insertion of LMA flexible</measure>
    <time_frame>During the anesthesia induction(up to 1 hour)</time_frame>
    <description>Ease of insertion of LMA flexible(very easy, easy, moerate, difficult, very difficult)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of gastric insufflation(body)</measure>
    <time_frame>During the surgery(up to 3 hours)</time_frame>
    <description>Incidence of gastric insufflation which was recognized in gastric body with ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of gastric insufflation recognized with the ausculation</measure>
    <time_frame>During the surgery(up to 3 hours)</time_frame>
    <description>Incidence of gastric insufflation recognized with the ausculation after finishing surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>peak pressure observed before, during, after surgery</measure>
    <time_frame>During the surgery(up to 3 hours)</time_frame>
    <description>peak pressure observed before, during, after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oropharyngeal leak pressure</measure>
    <time_frame>During the surgery(up to 3 hours)</time_frame>
    <description>oropharyngeal leak pressure will be assessed by setting the APL valve of the circle system at 30 cmH2O with fresh gas flow of 3 L/min after the surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the complication rate</measure>
    <time_frame>During the surgery and after surgery (up to 6 hours)</time_frame>
    <description>the complication rate such as desaturation, blood staining of LMA flexible, hoarseness, dental/lip/tongue injury, aspiration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">230</enrollment>
  <condition>Aspiration</condition>
  <arm_group>
    <arm_group_label>higher pressure</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lower pressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>lower pressure</intervention_name>
    <description>During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O</description>
    <arm_group_label>lower pressure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>higher pressure</intervention_name>
    <description>During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O</description>
    <arm_group_label>higher pressure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pediatric patients undergoing general anesthesia with LMA flexible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable vital sign, significant arrhythmia or hypotension, Shock&#xD;
&#xD;
          -  anticipated difficult intubation or the patient who have facial deformity&#xD;
&#xD;
          -  high risk of aspiration&#xD;
&#xD;
          -  recent upper respiratory tract infection history&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin-Tae Kim, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jin-Tae Kim, PhD</last_name>
    <phone>82-2-2072-3664</phone>
    <email>jintae73@gmail.com</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jin-Tae Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04494802
org study id: Gastric insufflation
nct id: NCT04494802
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Cuff inflation up to the maximum cuff pressure when using LMA flexible can cause sore throat
      and discomfort after the surgery, and if the surgery is unexpectedly prolonged, there can be
      a side effect that can cause ischemic damage around the neck. If keeping cuff pressure low
      will not increase gastric insufflation and there is no change in other outcome variables,
      keeping it low may have a positive effect on anesthesia management and outcome in children.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Incidence of gastric insufflation(antrum)
time frame: During the surgery(up to 3 hours)
description: Incidence of gastric insufflation which was recognized in gastric antrum with ultrasound
measure: The size of gastric antrum and body
time frame: During the surgery(up to 3 hours)
description: The size of gastric antrum and body assessed immediately after insertion of LMA flexible and after finishing the surgery
measure: Time for insertion of LMA flexible
time frame: During the anesthesia induction(up to 1 hour)
description: Time for insertion of LMA flexible
measure: Success rate of insertion of LMA flexible
time frame: During the anesthesia induction(up to 1 hour)
description: Success rate of insertion of LMA flexible
measure: The number of insertion attempt
time frame: During the anesthesia induction(up to 1 hour)
description: The number of insertion attempt
measure: The number and the type of additional manipulation for successful ventilation
time frame: During the surgery(up to 3 hours)
description: The number and the type of additional manipulation for successful ventilation
measure: Ease of insertion of LMA flexible
time frame: During the anesthesia induction(up to 1 hour)
description: Ease of insertion of LMA flexible(very easy, easy, moerate, difficult, very difficult)
measure: Incidence of gastric insufflation(body)
time frame: During the surgery(up to 3 hours)
description: Incidence of gastric insufflation which was recognized in gastric body with ultrasound
measure: Incidence of gastric insufflation recognized with the ausculation
time frame: During the surgery(up to 3 hours)
description: Incidence of gastric insufflation recognized with the ausculation after finishing surgery
measure: peak pressure observed before, during, after surgery
time frame: During the surgery(up to 3 hours)
description: peak pressure observed before, during, after surgery
measure: oropharyngeal leak pressure
time frame: During the surgery(up to 3 hours)
description: oropharyngeal leak pressure will be assessed by setting the APL valve of the circle system at 30 cmH2O with fresh gas flow of 3 L/min after the surgery
measure: the complication rate
time frame: During the surgery and after surgery (up to 6 hours)
description: the complication rate such as desaturation, blood staining of LMA flexible, hoarseness, dental/lip/tongue injury, aspiration
arm group label: higher pressure
arm group type: Placebo Comparator
description: During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O
arm group label: lower pressure
arm group type: Experimental
description: During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O
intervention type: Behavioral
intervention name: lower pressure
description: During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O
arm group label: lower pressure
intervention type: Behavioral
intervention name: higher pressure
description: During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O
arm group label: higher pressure
criteria: 
gender: All
minimum age: 1 Year
maximum age: 6 Years
healthy volunteers: No
last name: Jin-Tae Kim, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: Jin-Tae Kim, PhD
phone: 82-2-2072-3664
email: jintae73@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin-Tae Kim
investigator title: Professor
sharing ipd: Undecided