Hypovolemia Clinical Trial
Official title:
PP3D - Prospective Combined Validation of an Algorithm for Measurement of Mean Systemic Filling Pressure and Comparison of Invasively Measured Cardiac Output Versus Cardiac Output Calculated by 3D TOE and Carotid Ultrasound.
Prospective combined clinical validation of an algorithmic calculated mean systemic filling pressure (Pms-Nav) with the gold standard for Pms (Pms calculated from venous return curves during inspiratory hold procedures with incremental airway pressures; Pms-Insp). Secondary correlation between invasive cardiac output measurement versus 3D TOE and carotid echo doppler measured cardiac output.
Background of the study:
Volume-state in critically ill patients is a difficult parameter to determine, and knowledge
about it could make the difference between life or death concerning proper treatment.
Determination of volume state starts with adequate 3D transesophageal echocardiography (TOE)
in the operation room, including with non-invasive doppler carotid artery measures. TOE is a
standardly used method in cardiac surgery. Because echocardiography only gives information
about volume status at a certain timepoint, a real-time continuous value reflecting
volume-status is needed. "Mean systemic filling pressure (Pms)" appears to be a promising
value reflecting volume status. There is a reliable, but cumbersome method available which to
date serves as a gold standard to determine Pms (Pms calculated by constructing venous return
curves during incremental levels of airway pressure, thereby simulating a decrease in preload
--> Pms-Insp). However, this method cannot be used in daily clinical practice because it is
laborious and cumbersome. Therefore there is a need for a non-invasive methods measuring Pms,
which could now be determined by a computerized algorithm with the Navigator-device
(Pms-Nav). It is key to compare this Pms-Nav with its gold standard (Pms-Insp) in order to
establish a clinical validation for Pms-Nav.
Objective of the study:
1. Is there a good correlation between Pms-Nav and Pms-Insp?
2. Is there a good correlation between invasive continuous cardiac output measurement (by
thermodilution and pulse-contour analyse detected by the PiCCO-device) and 3D
transoesophageal echocardiography (TOE) and carotid echo doppler?
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