Clinical Validation of Algorithms for Mean Systemic Filling Pressure and Automated Cardiac Output (PP3D)

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.

Study Overview

• Status: Completed
• Conditions: Shock, Cardiogenic; Hypovolemia; Cardiac Failure; Shock Hypovolemic
• Intervention / Treatment: Diagnostic test: Mean systemic filling pressure

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?

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Netherlands
  • North Brabant
    • Eindhoven, North Brabant, Netherlands, 5623 EJ
      • Catharina hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Coronary Artery Bypass Surgery patients; 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.; Other Names: Measurement of cardiac output

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Hours

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven
• Investigators: Principal Investigator: LPB Meijs, MD, Catharina Ziekenhuis Eindhoven

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Intensive Care; Transesophageal echocardiography; Critical Care; Cardiac Output; Hypovolemia; Transpulmonary thermodilution; Mean Systemic Filling Pressure; Pms; Pmsf; Volume state; Cardiosurgery; Carotid ultrasound; Pulsed Wave; Inspiratory breath hold
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Heart Failure; Shock; Shock, Cardiogenic; Hypovolemia
• Other Study ID Numbers: NL67389.100.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No