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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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).


Sponsor: University of Schleswig-Holstein

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Schleswig-Holstein

Dates:
Date Received: December 3, 2012
Date Started: March 2012
Date Completion:
Last Updated: October 24, 2016
Last Verified: October 2016