Evaluation of Non-invasive Continuous Hemodynamic Measurement From Task Force CORE (NCT06007196) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of Non-invasive Continuous Hemodynamic Measurement From Task Force CORE
Austria70 participantsStarted 2023-09-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Difference in intraoperative cardiac output measurements between Task Force CORE compared with thermodilution during surgery