<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/NCT03792334</url>
  </required_header>
  <id_info>
    <org_study_id>1811-172-991</org_study_id>
    <nct_id>NCT03792334</nct_id>
  </id_info>
  <brief_title>Comparison of BIS and PIS in Children</brief_title>
  <official_title>A Comparison Between Patient State Index (PSI) and Bispectral Index (BIS) as Technologies for Monitor in Depth of Anesthesia in Children: A Prospective Observational Trial</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>
    <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>
      Comparison of bispectral index and patient sedation index during general anesthesia in&#xD;
      children&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the values of BIS and PSI of every 1 minute during general anesthesia in children&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">December 28, 2019</completion_date>
  <primary_completion_date type="Actual">December 26, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>correlation of BIS and PSI</measure>
    <time_frame>through study completion, an average of 2 hours</time_frame>
    <description>difference of BIS and PSI values</description>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Depth of Anesthesia Monitor</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>depth of anesthesia</intervention_name>
    <description>monitoring of depth of anesthesia</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        general anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  developmental delay&#xD;
&#xD;
          -  IICP&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hee-Soo Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SNUH</name>
      <address>
        <city>Seoul</city>
        <state>Jongnogu</state>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>December 8, 2020</last_update_submitted>
  <last_update_submitted_qc>December 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 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>Hee-Soo Kim</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03792334
org study id: 1811-172-991
nct id: NCT03792334
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comparison of bispectral index and patient sedation index during general anesthesia in
      children
the values of BIS and PSI of every 1 minute during general anesthesia in children
observational model: Case-Only
time perspective: Prospective
measure: correlation of BIS and PSI
time frame: through study completion, an average of 2 hours
description: difference of BIS and PSI values
intervention type: Device
intervention name: depth of anesthesia
description: monitoring of depth of anesthesia
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 12 Years
healthy volunteers: No
last name: Hee-Soo Kim, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Hee-Soo Kim
investigator title: Principal Investigator
mesh term: Anesthetics
sharing ipd: No