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

U

University Hospital Schleswig-Holstein (UKSH)

Status

Completed

Conditions

Cardiac Output, High

Treatments

Device: COPFX

Study type

Interventional

Funder types

Other

Identifiers

NCT02312505
AZ 162/10 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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).

Enrollment

65 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

65 participants in 1 patient group

COPFX
Other group
Description:
cardiac output by PulsioFlex® Monitoring system (COPFX)
Treatment:
Device: COPFX

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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