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

NCT06007196 | Unknown FDA Device

• 1 other identifier: Task_Force_01
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Hemodynamic Measurement; Non-invasive; Cardiac Output

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Differences in intraoperative hemodynamic measurements (blood pressure in mmHg) between Task Force CORE compared with thermodilution during surgery

  For the duration of surgery

• Differences in intraoperative hemodynamic measurements (stroke volume in ml) between Task Force CORE compared with thermodilution during surgery

  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

• Intraoperative continuous Cardioc Output measurements

  For the duration of surgery

Study Arms (1)

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.

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

Interventions

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

Continuous non-invasive Hemodynamic Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients, who undergo major abdominal surgery, which will require extended hemodynamic monitoring.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Medical University of Graz: collaborator

Study Sites (1)

Medical University of Graz

Graz, Styria, 8010, Austria

Location

Central Study Contacts

Christian Reiterer, MD

CONTACT

+43 40400; christian.reiterer@meduniwien.ac.at

Alexander Taschner, MD

CONTACT

+43 40400; alexander.taschner@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 23, 2023
• Study Start: September 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: September 30, 2024
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

AU (1)