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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Hemodynamic Measurement, Non-invasive, Cardiac Output

Intervention / Treatment
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* Device: non-invasive device (Task Force CORE(R) and Task Force CARDIO(R)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Continuous non-invasive Hemodynamic Monitoring<br>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)<br>* 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).<br>|

What is the study measuring?
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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 |