Clinical trial NCT06007196: Evaluation of Non-invasive Continuous Hemodynamic Measurement From Task Force CORE
Official title: Performance Evaluation of Non-invasive Continuous Hemodynamic Measurement From Task Force(R) CORE Versus Invasive Reference
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hemodynamic Measurement
Non-invasive
Cardiac Output
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Medical University of Graz
First posted: 2023-08-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients, who undergo major abdominal surgery, which will require extended hemodynamic monitoring.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in intraoperative cardiac output measurements between Task Force CORE compared with thermodilution during surgery
timeFrame: For the duration of surgery
Secondary outcomes:
measure: Differences in intraoperative hemodynamic measurements (blood pressure in mmHg) between Task Force CORE compared with thermodilution during surgery
timeFrame: For the duration of surgery
measure: Differences in intraoperative hemodynamic measurements (stroke volume in ml) between Task Force CORE compared with thermodilution during surgery
timeFrame: For the duration of surgery
measure: Differences in intraoperative hemodynamic measurements (stroke volume variation in %) between Task Force CORE compared with thermodilution during surgery
timeFrame: For the duration of surgery
measure: Intraoperative continuous Cardioc Output measurements
timeFrame: For the duration of surgery
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
References: