Comparison of a New Semi-invasive Monitoring System With Transpulmonary Thermodilution in Cardiac Surgery Patients

Study Overview
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Brief Summary
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The aim of the study is to investigate the accuracy of a new semi-invasive cardiac output monitoring system in patients undergoing elective cardiac surgery. The investigators hypothesize that the semi-invasive device may be affected by mean arterial pressure and systemic vascular resistance.

Detailed Description
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A recently introduced semi-invasive monitoring system consists of an algorithm that provides beat-to-beat measurement of CI by analysis of the arterial blood pressure tracing. By using the autocalibration mode this software calculates the individual aortic compliance and systemic vascular resistance by taking patient data like age, height, weight and gender into account. After estimation of beat-to-beat stroke volume, a subsequent multiplication by the heart rate delivers pulse contour cardiac index. Furthermore, this device offers the opportunity for external calibration by a reference technique, e.g. pulmonary or transpulmonary thermodilution. The aim of the present study was to investigate the accuracy and trending ability of autocalibrated semi-invasive CI by a new arterial waveform analysis compared with transpulmonary thermodilution before and after cardiopulmonary bypass (CPB).

Official Title
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Estimation of Cardiac Output by a New Semi-invasive Monitoring System: Accuracy and Limitations

Conditions
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Cardiac Output, High

Intervention / Treatment
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* Device: COPFX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective coronary artery bypass grafting Personal declaration of consent to the study Exclusion Criteria: Patients <18 years of age A left ventricular ejection fraction ≤0.5 Emergency procedures Patients with haemodynamic instability requiring continuous pharmacologic support Patients with intracardiac shunts Severe aortic-, tricuspid- or mitral stenosis or insufficiency Mechanical circulatory support.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: COPFX<br>cardiac output by PulsioFlex® Monitoring system (COPFX) | Device: COPFX<br>* cardiac Output by semi-invasive pulse contour analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac output by pulse contour Analysis compared with transpulmonary thermodilution | plotting cardiac output by a questionnaire, Statistics: correlation coefficients, Bland-Altman Analysis, trending ability by four Quadrant plots | participants will be followed for the start and the end of operation, on the average of 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac output monitoring, semi-invasive pulse contour analysis, transpulmonary thermodilution