An observational study in Shock, Cardiogenic, Shock Hypovolemic and Hypovolemia, sponsored by Catharina Ziekenhuis Eindhoven. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-18.
Sponsored by Catharina Ziekenhuis Eindhoven · Observational
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:
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 18 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Catharina Ziekenhuis Eindhoven is the lead sponsor of 80 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing coronary artery bypass grafting with a good left and right ventricular ejection fraction, no significant valvular insufficiencies/stenoses and no significant comorbidity.
Exclusion Criteria:
Patients undergoing coronary artery bypass surgery (on-pump / off-pump) measured perioperatively and postoperatively.
Diagnostic Test: Mean systemic filling pressure
Peri- and postoperative measurement of continuous cardiac output with thermodilution derived pulse contour calculated device (PiCCO). Estimation of mean systemic filling pressure using a computerized algorithm and by creating venous return curves with inspiratory hold maneuvers, thereby extrapolating the VR-curve until mean systemic filling pressure is calculated.
Also known as: Measurement of cardiac output
Clinical validation of Pms-algorithm
To determine a correlation between Pms calculated by a computerized algorithm by Navigator(TM) (Pms-Nav) and the gold standard for determining Pms: Pms-Insp. The latter is calculated by performing inspiratory breath holds during incremental airway pressure levels thereby simulating a decrease in preload which, by extrapolating a venous return curve, leads to the true Pms when the curve intersects the x-axis (Pms-Insp).
Time frame: Hours
Correlation invasive continuous cardiac output and 3D-TOE / carotid artery pulsed wave CO measurement.
Correlation between invasively measured continuous cardiac output (CO) and CO measured by a automated 3D-TOE algorithm and carotid artery PW-measured CO.
Time frame: Hours
Plan to share: No — No sharing
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Catharina Ziekenhuis Eindhoven