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

Not Applicable

Completed

• Conditions: Cardiac Output, High

• Registration Number: NCT02312505
• Lead Sponsor: University Hospital Schleswig-Holstein

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).

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-12-03
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Study First Submitted QC: 2014-12-06
• Study First Posted: 2014-12-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
cardiac output by pulse contour Analysis compared with transpulmonary thermodilution	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

Trial Locations

Locations (1)

Department of Anaesthesiology and Intensive Care Medicine; 🇩🇪 Kiel, Schleswig-Holstein, Germany