Status:
UNKNOWN
Evaluation of Non-invasive Continuous Hemodynamic Measurement From Task Force CORE
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
Medical University of Graz
Conditions:
Hemodynamic Measurement
Non-invasive
Eligibility:
All Genders
18+ years
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06007196
Start Date
September 1 2023
End Date
September 30 2024
Last Update
August 25 2023
Active Locations (1)
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1
Medical University of Graz
Graz, Styria, Austria, 8010