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

Medical University of Vienna

Status: Not yet enrolling

Conditions: Non-invasive; Cardiac Output; Hemodynamic Measurement

Treatments: Device: non-invasive device (Task Force CORE(R) and Task Force CARDIO(R)

Study type: Observational

Funder types: Other

Identifiers

NCT06007196

Task_Force_01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 1 patient group

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.

Treatment:

Device: non-invasive device (Task Force CORE(R) and Task Force CARDIO(R)