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Completed

NCT Number: NCT02312505

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Intensive Care Medicine

Kiel, Schleswig-Holstein, 24105, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

COPFX

Device

cardiac Output by semi-invasive pulse contour analysis

Primary outcomes

  1. cardiac output by pulse contour Analysis compared with transpulmonary thermodilution

    Time frame: participants will be followed for the start and the end of operation, on the average of 4 hours

    plotting cardiac output by a questionnaire, Statistics: correlation coefficients, Bland-Altman Analysis, trending ability by four Quadrant plots

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 9, 2014
Registry last updated
Oct 25, 2016

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.

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