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/NCT05996965</url>
    </required_header>
    <id_info>
      <org_study_id>HemoVista</org_study_id>
      <nct_id>NCT05996965</nct_id>
    </id_info>
    <brief_title>Evaluation of Clinical Utility of Non-invasive Hemodynamic Monitoring Device</brief_title>
    <official_title>Evaluation of Clinical Utility of Non-invasive Hemodynamic Monitoring Device (HemoVista™) in the Clinical Filed</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>
        In patients undergoing surgery under general anesthesia, the clinical utility of non-invasive&#xD;
        hemodynamic status monitoring equipment using HemoVista is compared with invasive hemodynamic&#xD;
        status monitoring equipment FloTrac.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        For patients who are scheduled to monitor invasive blood pressure, invasive hemodynamic&#xD;
        monitoring using FloTrac and additional HemoVista sensors are attached and output data are&#xD;
        obtained at the same time during general anesthesia. FloTrac is used to conduct conventional&#xD;
        anesthesia and fluid therapy, and the accuracy of HemoVista, a non-invasive hemodynamic&#xD;
        monitoring equipment, is compared through prospective observational studies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 10, 2024</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>degree of agreement in cardiac output</measure>
      <time_frame>during surgery</time_frame>
      <description>degree of agreement in cardiac output between HemoVista and FloTrac</description>
    </primary_outcome>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Cardiovascular Complication</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>HemoVista</intervention_name>
      <description>additional attatchment of non-invasive hemodynamic monitoring HemoVista with FloTrac</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients aged 20 or older&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients aged 20 or older who undergo surgery under general anesthesia for more&#xD;
               than two hours&#xD;
  &#xD;
            -  invasive close hemodynamic monitoring with FloTrac is needed&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  problems in site where HemoVista is attached&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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>professor</investigator_title>
    </responsible_party>
    <!-- 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/NCT05996965
  org study id: HemoVista
  nct id: NCT05996965
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In patients undergoing surgery under general anesthesia, the clinical utility of non-invasive
        hemodynamic status monitoring equipment using HemoVista is compared with invasive hemodynamic
        status monitoring equipment FloTrac.
  For patients who are scheduled to monitor invasive blood pressure, invasive hemodynamic
        monitoring using FloTrac and additional HemoVista sensors are attached and output data are
        obtained at the same time during general anesthesia. FloTrac is used to conduct conventional
        anesthesia and fluid therapy, and the accuracy of HemoVista, a non-invasive hemodynamic
        monitoring equipment, is compared through prospective observational studies.
  observational model: Cohort
  time perspective: Prospective
  measure: degree of agreement in cardiac output
  time frame: during surgery
  description: degree of agreement in cardiac output between HemoVista and FloTrac
  intervention type: Other
  intervention name: HemoVista
  description: additional attatchment of non-invasive hemodynamic monitoring HemoVista with FloTrac
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Seoul National University Hospital
  investigator full name: Hee-Soo Kim
  investigator title: professor