Evaluation of Non-invasive Continuous Hemodynamic Measurement From Task Force CORE

Performance Evaluation of Non-invasive Continuous Hemodynamic Measurement From Task Force(R) CORE Versus Invasive Reference

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Output; Hemodynamic Measurement; Non-invasive
• Intervention / Treatment: Device: non-invasive device (Task Force CORE(R) and Task Force CARDIO(R)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Christian Reiterer, MD; Phone Number: 20760 +43 40400; Email: christian.reiterer@meduniwien.ac.at
• Study Contact Backup: Name: Alexander Taschner, MD; Phone Number: 20760 +43 40400; Email: alexander.taschner@meduniwien.ac.at

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8010
      • Medical University of Graz
      • Contact: David West, MD; Email: david.west@medunigraz.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adult patients, who undergo major abdominal surgery, which will require extended hemodynamic monitoring.

Description

Inclusion Criteria:

• Adult patients (patients aged at least 18 years)
• Patients undergoing major abdominal surgery who require invasive extended hemodynamic monitoring (trans pulmonary thermodilution via PiCCO and invasive blood pressure monitoring with radial artery catheter) according to clinical standard of care
• Patients with intact perfusion of both hands evidenced by a positive Allen's test
• Patients given written informed consent to participate in the study

Exclusion Criteria:

• Patients with vascular impairments at the sites of non-invasive blood pressure measurement (fingers or upper arms)
• Patients with significant edema in the fingers
• Patients with ventricular assist devices or extracorporeal life-supporting devices
• Subjects not passing the Allen's test for both hands
• Patients who obtain vasoactive medications on the same arm as used for upper-arm Task Force blood pressure measurements
• Patients with a large lateral difference in blood pressure (> 15mmHg for systolic blood pressure and/or >10 mmHg for diastolic blood pressure) or with same arm measurement differences > 10 mmHg in systolic or diastolic blood pressure during assessment of lateral differences
• Patients who, in addition to invasive blood pressure monitoring, require non-invasive blood pressure measurements unrelated to the investigational device

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Continuous non-invasive Hemodynamic Monitoring; 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.	Device: non-invasive device (Task Force CORE(R) and Task Force CARDIO(R); 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in intraoperative cardiac output measurements between Task Force CORE compared with thermodilution during surgery	Intraoperative performance of cardiac output values derived by the Task Force CORE system compared with cardiac output measurements derived by thermodilution measurements.	For the duration of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in intraoperative hemodynamic measurements (blood pressure in mmHg) between Task Force CORE compared with thermodilution during surgery	Intraoperative evaluation of the performance of Task Force variable blood pressure (in mmHg) throughout surgery compared to simultaneous invasive measurements.	For the duration of surgery
Differences in intraoperative hemodynamic measurements (stroke volume in ml) between Task Force CORE compared with thermodilution during surgery	Intraoperative evaluation of the performance of Task Force variable stroke volume (in ml) throughout surgery compared to simultaneous invasive measurements.	For the duration of surgery
Differences in intraoperative hemodynamic measurements (stroke volume variation in %) between Task Force CORE compared with thermodilution during surgery	Intraoperative evaluation of the performance of Task Force variable stroke volume variation (in %) throughout surgery compared to simultaneous invasive measurements.	For the duration of surgery
Intraoperative continuous Cardioc Output measurements	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).	For the duration of surgery

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Task_Force_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes