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

NCT ID: NCT04202432

Last Updated: 2019-12-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2019-08-30

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?

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Coronary Artery Bypass Surgery patients

Patients undergoing coronary artery bypass surgery (on-pump / off-pump) measured perioperatively and postoperatively.

Mean systemic filling pressure

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Measurement of cardiac output

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: lead

Responsible Party

L.P.B. Meijs

Cardiologist, fellow intensive care medicine, PhD candidate Intensive Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

LPB Meijs, MD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis Eindhoven

Locations

Catharina Hospital

Eindhoven, North Brabant, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 33791920 (View on PubMed)

Other Identifiers

NL67389.100.18

Identifier Type: -

Identifier Source: org_study_id