Performance Evaluation of Non-invasive Continuous Hemodynamic Measurement From Task Force(R) CORE Versus Invasive Reference
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Medical University of Vienna
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Difference in intraoperative cardiac output measurements between Task Force CORE compared with thermodilution during surgery
Study Overview
Brief Summary
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
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Difference in intraoperative cardiac output measurements between Task Force CORE compared with thermodilution during surgery
Time Frame: For the duration of surgery
Intraoperative performance of cardiac output values derived by the Task Force CORE system compared with cardiac output measurements derived by thermodilution measurements.
Secondary Outcomes
- Differences in intraoperative hemodynamic measurements (stroke volume in ml) between Task Force CORE compared with thermodilution during surgery(For the duration of surgery)
- Intraoperative continuous Cardioc Output measurements(For the duration of surgery)
- Differences in intraoperative hemodynamic measurements (stroke volume variation in %) between Task Force CORE compared with thermodilution during surgery(For the duration of surgery)
- Differences in intraoperative hemodynamic measurements (blood pressure in mmHg) between Task Force CORE compared with thermodilution during surgery(For the duration of surgery)
Investigators
Christian Reiterer
Principal Investigator
Medical University of Vienna