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

NCT ID: NCT06007196

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-09-30

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.

Conditions

Hemodynamic Measurement; Non-invasive; Cardiac Output

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Christian Reiterer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Graz

Graz, Styria, Austria

Countries

Austria

Central Contacts

Christian Reiterer, MD

Role: CONTACT

christian.reiterer@meduniwien.ac.at

+43 40400 ext. 20760

Alexander Taschner, MD

Role: CONTACT

alexander.taschner@meduniwien.ac.at

+43 40400 ext. 20760

Facility Contacts

David West, MD

Role: primary

david.west@medunigraz.at

Other Identifiers

Task_Force_01

Identifier Type: -

Identifier Source: org_study_id