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/NCT06007196</url>
    </required_header>
    <id_info>
      <org_study_id>Task_Force_01</org_study_id>
      <nct_id>NCT06007196</nct_id>
    </id_info>
    <brief_title>Evaluation of Non-invasive Continuous Hemodynamic Measurement From Task Force CORE</brief_title>
    <official_title>Performance Evaluation of Non-invasive Continuous Hemodynamic Measurement From Task Force(R) CORE Versus Invasive Reference</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Vienna</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Medical University of Graz</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Medical University of Vienna</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Validation of hemodynamic measurements using the non-invasive Task Force Core(R) and Task&#xD;
        Force Cardio(R) device with invasive hemodynamic measurements using the thermodilution&#xD;
        technique (PICCO device).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigational device, Task Force® CORE (TFC, CNSystems Medizintechnik GmbH, Graz,&#xD;
        Austria) together with the Task Force® CARDIO (TFCARDIO, CNSystems Medizintechnik GmbH, Graz,&#xD;
        Austria) medical device software, is a new CE-marked medical device for continuous&#xD;
        non-invasive determination of blood pressure (BP), cardiac output (CO) and derived parameters&#xD;
        based on the well established CNAP® (continuous non-invasive arterial pressure) technology by&#xD;
        CNSystems. The primary aim of this prospective, method comparison, open, multi-center study&#xD;
        is data acquisition for the performance evaluation of the TFC in comparison with invasive&#xD;
        reference methods (i.e. transpulmonary thermodilution, invasive blood pressure with radial&#xD;
        artery catheter). The setting of the study will be the Operating Room (OR). This setting&#xD;
        allows the comparison of the investigational device's cardiac output (CO) to invasive CO as&#xD;
        well as of BP and derived hemodynamic parameters like Stroke Volume (SV), and Systemic&#xD;
        Vascular Resistance (SVR). Measurements will be performed during the perioperative period,&#xD;
        starting 15 minutes after the first skin incision.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</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>Difference in intraoperative cardiac output measurements between Task Force CORE compared with thermodilution during surgery</measure>
      <time_frame>For the duration of surgery</time_frame>
      <description>Intraoperative performance of cardiac output values derived by the Task Force CORE system compared with cardiac output measurements derived by thermodilution measurements.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Differences in intraoperative hemodynamic measurements (blood pressure in mmHg) between Task Force CORE compared with thermodilution during surgery</measure>
      <time_frame>For the duration of surgery</time_frame>
      <description>Intraoperative evaluation of the performance of Task Force variable blood pressure (in mmHg) throughout surgery compared to simultaneous invasive measurements.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Differences in intraoperative hemodynamic measurements (stroke volume in ml) between Task Force CORE compared with thermodilution during surgery</measure>
      <time_frame>For the duration of surgery</time_frame>
      <description>Intraoperative evaluation of the performance of Task Force variable stroke volume (in ml) throughout surgery compared to simultaneous invasive measurements.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Differences in intraoperative hemodynamic measurements (stroke volume variation in %) between Task Force CORE compared with thermodilution during surgery</measure>
      <time_frame>For the duration of surgery</time_frame>
      <description>Intraoperative evaluation of the performance of Task Force variable stroke volume variation (in %) throughout surgery compared to simultaneous invasive measurements.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraoperative continuous Cardioc Output measurements</measure>
      <time_frame>For the duration of surgery</time_frame>
      <description>The comparison of intraoperative continuous cardiac output measurements derived by the Task Force device with continuous invasive cardiac output measurements derived by the PiCCO throughout surgery or before, during and after clinically indicated interventions (e.g. medication, passive leg raising, fluid challenge).</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Hemodynamic Measurement</condition>
    <condition>Non-invasive</condition>
    <condition>Cardiac Output</condition>
    <arm_group>
      <arm_group_label>Continuous non-invasive Hemodynamic Monitoring</arm_group_label>
      <description>Continuous non-invasive Hemodynamic Monitoring (Task Force CORE(R) and Task Force CARDIO(R)) will be compared to invasive thermodilution cardiac output measurements in all patients.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>non-invasive device (Task Force CORE(R) and Task Force CARDIO(R)</intervention_name>
      <description>Intraoperative cardiac output will be measured using the non-invasive device (Task Force CORE(R) and Task Force CARDIO(R) and will be compared with the invasive thermodilution method (PiCCO).</description>
      <arm_group_label>Continuous non-invasive Hemodynamic Monitoring</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients, who undergo major abdominal surgery, which will require extended&#xD;
          hemodynamic monitoring.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients (patients aged at least 18 years)&#xD;
  &#xD;
            -  Patients undergoing major abdominal surgery who require invasive extended hemodynamic&#xD;
               monitoring (trans pulmonary thermodilution via PiCCO and invasive blood pressure&#xD;
               monitoring with radial artery catheter) according to clinical standard of care&#xD;
  &#xD;
            -  Patients with intact perfusion of both hands evidenced by a positive Allen's test&#xD;
  &#xD;
            -  Patients given written informed consent to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with vascular impairments at the sites of non-invasive blood pressure&#xD;
               measurement (fingers or upper arms)&#xD;
  &#xD;
            -  Patients with significant edema in the fingers&#xD;
  &#xD;
            -  Patients with ventricular assist devices or extracorporeal life-supporting devices&#xD;
  &#xD;
            -  Subjects not passing the Allen's test for both hands&#xD;
  &#xD;
            -  Patients who obtain vasoactive medications on the same arm as used for upper-arm Task&#xD;
               Force blood pressure measurements&#xD;
  &#xD;
            -  Patients with a large lateral difference in blood pressure (&gt; 15mmHg for systolic&#xD;
               blood pressure and/or &gt;10 mmHg for diastolic blood pressure) or with same arm&#xD;
               measurement differences &gt; 10 mmHg in systolic or diastolic blood pressure during&#xD;
               assessment of lateral differences&#xD;
  &#xD;
            -  Patients who, in addition to invasive blood pressure monitoring, require non-invasive&#xD;
               blood pressure measurements unrelated to the investigational device&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Christian Reiterer, MD</last_name>
      <phone>+43 40400</phone>
      <phone_ext>20760</phone_ext>
      <email>christian.reiterer@meduniwien.ac.at</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alexander Taschner, MD</last_name>
      <phone>+43 40400</phone>
      <phone_ext>20760</phone_ext>
      <email>alexander.taschner@meduniwien.ac.at</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Medical University of Graz</name>
        <address>
          <city>Graz</city>
          <state>Styria</state>
          <zip>8010</zip>
          <country>Austria</country>
        </address>
      </facility>
      <contact>
        <last_name>David West, MD</last_name>
        <email>david.west@medunigraz.at</email>
      </contact>
    </location>
    <location_countries>
      <country>Austria</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
      <investigator_full_name>Christian Reiterer</investigator_full_name>
      <investigator_title>Principal Investigator</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/NCT06007196
  org study id: Task_Force_01
  nct id: NCT06007196
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  Validation of hemodynamic measurements using the non-invasive Task Force Core(R) and Task
        Force Cardio(R) device with invasive hemodynamic measurements using the thermodilution
        technique (PICCO device).
  The investigational device, Task Force® CORE (TFC, CNSystems Medizintechnik GmbH, Graz,
        Austria) together with the Task Force® CARDIO (TFCARDIO, CNSystems Medizintechnik GmbH, Graz,
        Austria) medical device software, is a new CE-marked medical device for continuous
        non-invasive determination of blood pressure (BP), cardiac output (CO) and derived parameters
        based on the well established CNAP® (continuous non-invasive arterial pressure) technology by
        CNSystems. The primary aim of this prospective, method comparison, open, multi-center study
        is data acquisition for the performance evaluation of the TFC in comparison with invasive
        reference methods (i.e. transpulmonary thermodilution, invasive blood pressure with radial
        artery catheter). The setting of the study will be the Operating Room (OR). This setting
        allows the comparison of the investigational device's cardiac output (CO) to invasive CO as
        well as of BP and derived hemodynamic parameters like Stroke Volume (SV), and Systemic
        Vascular Resistance (SVR). Measurements will be performed during the perioperative period,
        starting 15 minutes after the first skin incision.
  observational model: Other
  time perspective: Prospective
  measure: Difference in intraoperative cardiac output measurements between Task Force CORE compared with thermodilution during surgery
  time frame: For the duration of surgery
  description: Intraoperative performance of cardiac output values derived by the Task Force CORE system compared with cardiac output measurements derived by thermodilution measurements.
  measure: Differences in intraoperative hemodynamic measurements (blood pressure in mmHg) between Task Force CORE compared with thermodilution during surgery
  time frame: For the duration of surgery
  description: Intraoperative evaluation of the performance of Task Force variable blood pressure (in mmHg) throughout surgery compared to simultaneous invasive measurements.
  measure: Differences in intraoperative hemodynamic measurements (stroke volume in ml) between Task Force CORE compared with thermodilution during surgery
  time frame: For the duration of surgery
  description: Intraoperative evaluation of the performance of Task Force variable stroke volume (in ml) throughout surgery compared to simultaneous invasive measurements.
  measure: Differences in intraoperative hemodynamic measurements (stroke volume variation in %) between Task Force CORE compared with thermodilution during surgery
  time frame: For the duration of surgery
  description: Intraoperative evaluation of the performance of Task Force variable stroke volume variation (in %) throughout surgery compared to simultaneous invasive measurements.
  measure: Intraoperative continuous Cardioc Output measurements
  time frame: For the duration of surgery
  description: The comparison of intraoperative continuous cardiac output measurements derived by the Task Force device with continuous invasive cardiac output measurements derived by the PiCCO throughout surgery or before, during and after clinically indicated interventions (e.g. medication, passive leg raising, fluid challenge).
  arm group label: Continuous non-invasive Hemodynamic Monitoring
  description: Continuous non-invasive Hemodynamic Monitoring (Task Force CORE(R) and Task Force CARDIO(R)) will be compared to invasive thermodilution cardiac output measurements in all patients.
  intervention type: Device
  intervention name: non-invasive device (Task Force CORE(R) and Task Force CARDIO(R)
  description: Intraoperative cardiac output will be measured using the non-invasive device (Task Force CORE(R) and Task Force CARDIO(R) and will be compared with the invasive thermodilution method (PiCCO).
  arm group label: Continuous non-invasive Hemodynamic Monitoring
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Christian Reiterer, MD
  phone: +43 40400
  phone ext: 20760
  email: christian.reiterer@meduniwien.ac.at
  last name: Alexander Taschner, MD
  phone: +43 40400
  phone ext: 20760
  email: alexander.taschner@meduniwien.ac.at
  facility: 
  contact: 
  country: Austria
  responsible party type: Principal Investigator
  investigator affiliation: Medical University of Vienna
  investigator full name: Christian Reiterer
  investigator title: Principal Investigator