xml: <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/NCT05963256</url>
    </required_header>
    <id_info>
      <org_study_id>2023-01-056</org_study_id>
      <nct_id>NCT05963256</nct_id>
    </id_info>
    <brief_title>Prediction Model for TOF</brief_title>
    <official_title>Investigation for Development of Predictive Model for Train of Four (TOF)% for Neurophysiological Monitoring During Neuroanesthesia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eunah Cho, MD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kangbuk Samsung 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>
        This study was aimed to investigate a prediction model for predicting train-of-four (TOF) 50%&#xD;
        in patients undergoing neurosurgery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">July 20, 2024</completion_date>
    <primary_completion_date type="Actual">July 20, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Train-of-four (TOF) ratio</measure>
      <time_frame>30 minutes after reaching the TOF plateau</time_frame>
      <description>The ratio of the height of the fourth muscle response to the first one following the nerve stimulation</description>
    </primary_outcome>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Neurophysiologic Monitoring</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Twitch Electrode Array</intervention_name>
      <description>Monitor train-of-four (TOF) count and percentage</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patient undergoing neurosurgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patient undergoing neurosurgery&#xD;
  &#xD;
            -  scheduled for intra-operative neurophysiological monitoring&#xD;
  &#xD;
            -  American Society of Anesthesiologists physical class I, II, III&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  unable to monitor train-of-four&#xD;
  &#xD;
            -  decline to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eunah Cho, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>KangbukSamsung Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eunah Cho, PhD</last_name>
      <phone>82-10-9480-0531</phone>
      <email>mintflavored@naver.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Eunah Cho</name>
        <address>
          <city>Seoul</city>
          <zip>03181</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eunah Cho, PhD</last_name>
        <phone>821094800531</phone>
        <email>mintflavored@naver.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Kangbuk Samsung Hospital</investigator_affiliation>
      <investigator_full_name>Eunah Cho, MD</investigator_full_name>
      <investigator_title>Assistant 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>
  
  
text: 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/NCT05963256
  org study id: 2023-01-056
  nct id: NCT05963256
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study was aimed to investigate a prediction model for predicting train-of-four (TOF) 50%
        in patients undergoing neurosurgery.
  observational model: Cohort
  time perspective: Prospective
  measure: Train-of-four (TOF) ratio
  time frame: 30 minutes after reaching the TOF plateau
  description: The ratio of the height of the fourth muscle response to the first one following the nerve stimulation
  intervention type: Device
  intervention name: Twitch Electrode Array
  description: Monitor train-of-four (TOF) count and percentage
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Eunah Cho, PhD
  role: Principal Investigator
  affiliation: KangbukSamsung Hospital
  last name: Eunah Cho, PhD
  phone: 82-10-9480-0531
  email: mintflavored@naver.com
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor-Investigator
  investigator affiliation: Kangbuk Samsung Hospital
  investigator full name: Eunah Cho, MD
  investigator title: Assistant Professor
  sharing ipd: Undecided