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

Launched by MEDICAL UNIVERSITY OF VIENNA · Aug 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new non-invasive device called Task Force CORE, which measures heart function and blood flow without needing to insert any tubes or needles. The goal is to see how well this device works compared to a standard method that does involve more invasive procedures. The trial will involve adult patients aged 18 and older who are scheduled for major abdominal surgery and need careful monitoring of their heart and blood flow during and after the procedure.

To be eligible for the study, patients must have good blood flow in both hands and be able to give consent to participate. However, patients with certain conditions, such as significant swelling in the fingers or those using specific heart support devices, won't be able to join. If you participate, you will receive both the new non-invasive measurement and the standard invasive monitoring to compare the two methods. It’s important to know that this study is not yet recruiting participants, but it aims to improve how doctors monitor heart function in patients undergoing surgery.

Gender

ALL

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