Atrial Fibrillation Clinical Trial
Official title:
Validation of Non-invasive Blood Pressure and Cardiac-output Measurement by Using Applanation Tonometry in Cardiological Patients
To evaluate and to validate accuracy, precision and trending ability of blood pressure and
cardiac output measurement by applanation tonometry in cardiological patients having:
- atrial fibrillation
- severe impaired leftventricular function
- severe aortic valve stenosis
- patients having left ventricular assist device
Experimental measurement: continuous blood pressure measurement and cardiac output
measurement is performed by the T-Line 200 pro device (Tensys Medical Inc., San Diego, USA)
Control measurement: gold-standard continuous blood pressure measurement is performed by
invasive blood pressure measurement by arterial cannulation and cardiac output reference is
assessed by transcardiopulmonary thermodilution
Increasing complexity of medical interventions and critical care treatment in an elderly
getting population requires precise and accurate hemodynamic monitoring.(1) However,
advanced invasive hemodynamic monitoring is often combined with complications by arterial or
central venous catheterization. Complications such as vessel harming, infection, cardiac
arrhythmias and nervous lesions are likely to occur.(2-4) Therefore, in the past various
techniques of minimal- or non-invasive hemodynamic monitoring devices have been
evaluated.(5, 6) One of the very promising technique is continuous non-invasive blood
pressure monitoring by applanation tonometry. Published data revealed efficacy of this
technique. (7) However, ability of this technique remains unclear in patients suffering from
cardiological pathologies leading to changing stroke volumes as in arterial fibrillation, to
highly reduces stroke volume as in severe impaired left-ventricular function or in severe
aortic valve stenosis. Further, ability of applanation tonometry in patients without having
pulsatile blood flow such as in patients with left-ventricular assist device remains
unclear. Therefore, validation of this technique should be performed in the presented study.
Further development of applanation tonometry including pulse contour analysis now enables
assessment of cardiac output. However, till now there is limited data assessing validation
cardiac output measurement by this method. Cardiac output validation should also be
performed in the planed clinical study.
;
Observational Model: Case-Only, Time Perspective: Prospective
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