Skip to main content
OpenTrials
Completed

NCT Number: NCT04202432

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shock, Cardiogenic Cardiac Failure Cardiovascular Diseases Heart Diseases Heart Failure Hypovolemia Infarction Ischemia Menstruation Disturbances Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Premenstrual Syndrome Shock Shock Hypovolemic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

About this study

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:

  • Is there a good correlation between Pms-Nav and Pms-Insp?
  • 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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mean systemic filling pressure

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.

Other names: Measurement of cardiac output

Primary outcomes

  1. Clinical validation of Pms-algorithm

    Time frame: Hours

    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).

Secondary outcomes

  1. Correlation invasive continuous cardiac output and 3D-TOE / carotid artery pulsed wave CO measurement.

    Time frame: Hours

    Correlation between invasively measured continuous cardiac output (CO) and CO measured by a automated 3D-TOE algorithm and carotid artery PW-measured CO.

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Registry information

Official study 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.

Acronym: PP3D

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 17, 2019
Registry last updated
Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.