Clinical trial NCT04202432: Clinical Validation of Algorithms for Mean Systemic Filling Pressure and Automated Cardiac Output
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shock, Cardiogenic
Shock Hypovolemic
Hypovolemia
Cardiac Failure
Keywords: Mean Systemic Filling Pressure
Pms
Pmsf
Hypovolemia
Cardiac Output
Transpulmonary thermodilution
Transesophageal echocardiography
Volume state
Critical Care
Cardiosurgery
Intensive Care
Carotid ultrasound
Pulsed Wave
Inspiratory breath hold
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing coronary artery bypass grafting with a good left and right ventricular ejection fraction, no significant valvular insufficiencies/stenoses and no significant comorbidity.

Brief summary: 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.

Detailed description: 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?

Eligibility criteria: Inclusion Criteria:

* Good left and right ventricular ejection fraction
* No significant valvular insufficiencies/stenoses
* No significant comorbidity
* Signed informed consent
* Elective coronary artery bypass surgery
* Postoperative mechanically ventilated admitted to the PACU

Exclusion Criteria:

* Withdrawal informed consent
* History of pneumonectomy of lobectomy
* Mechanical support of circulation
* COPD Gold 3 or 4
* Complications during surgery
* Postoperative bleeding \>50mL/15 minutes after admission to PACU - No thoracic drain in pleura
* Postoperative pneumothorax
* Participation in other research studies/trials
* Elevated intra-abdominal surgery (\>12 mmHg)

Primary outcomes:
measure: Clinical validation of Pms-algorithm
timeFrame: Hours
Secondary outcomes:
measure: Correlation invasive continuous cardiac output and 3D-TOE / carotid artery pulsed wave CO measurement.
timeFrame: Hours
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: North Brabant
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: LPB Meijs, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meijs LPB, van Houte J, Conjaerts BCM, Bindels AJGH, Bouwman A, Houterman S, Bakker J. Clinical validation of a computerized algorithm to determine mean systemic filling pressure. J Clin Monit Comput. 2022 Feb;36(1):191-198. doi: 10.1007/s10877-020-00636-2. Epub 2021 Mar 31.