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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02312505
Enrollment
65
Registered
2014-12-09
Start date
2012-03-31
Completion date
2014-12-31
Last updated
2016-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Output, High

Keywords

cardiac output monitoring, semi-invasive pulse contour analysis, transpulmonary thermodilution

Brief summary

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

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).

Interventions

DEVICECOPFX

cardiac Output by semi-invasive pulse contour analysis

Sponsors

University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
cardiac output by pulse contour Analysis compared with transpulmonary thermodilutionparticipants will be followed for the start and the end of operation, on the average of 4 hoursplotting cardiac output by a questionnaire, Statistics: correlation coefficients, Bland-Altman Analysis, trending ability by four Quadrant plots

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026