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Clinical validation of a new thermodilution system for the assessment of cardiac output and volumetric parameters

Nicholas Kiefer1*, Christoph K Hofer2, Gernot Marx3, Martin Geisen2, Raphaël Giraud4, Nils Siegenthaler4, Andreas Hoeft1, Karim Bendjelid4 and Steffen Rex3

Author Affiliations

1 Department of Anesthesiology and Intensive Care Medicine, University of Bonn, Sigmund-Freud-Straße 25, 53105 Bonn, Germany

2 Institute of Anaesthesiology and Intensive Care Medicine, Triemli City Hospital Zurich, Birmensdorferstrasse 497, 8063 Zürich, Switzerland

3 Department of Anaesthesiology, University Hospital Aachen, RWTH Aachen Pauwelsstraße 30, 52074 Aachen, Germany

4 Intensive Care Service, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 4, 1211 Genève 14, Switzerland

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Critical Care 2012, 16:R98 doi:10.1186/cc11366

Published: 30 May 2012

Abstract

Introduction

Transpulmonary thermodilution is used to measure cardiac output (CO), global end-diastolic volume (GEDV) and extravascular lung water (EVLW). A system has been introduced (VolumeView/EV1000™ system, Edwards Lifesciences, Irvine CA, USA) that employs a novel algorithm for the mathematical analysis of the thermodilution curve. Our aim was to evaluate the agreement of this method with the established PiCCO™ method (Pulsion Medical Systems SE, Munich, Germany, clinicaltrials.gov identifier: NCT01405040)

Methods

Seventy-two critically ill patients with clinical indication for advanced hemodynamic monitoring were included in this prospective, multicenter, observational study. During a 72-hour observation period, 443 sets of thermodilution measurements were performed with the new system. These measurements were electronically recorded, converted into an analog resistance signal and then re-analyzed by a PiCCO2™ device (Pulsion Medical Systems SE).

Results

For CO, GEDV, and EVLW, the systems showed a high correlation (r2 = 0.981, 0.926 and 0.971, respectively), minimal bias (0.2 L/minute, 29.4 ml and 36.8 ml), and a low percentage error (9.7%, 11.5% and 12.2%). Changes in CO, GEDV and EVLW were tracked with a high concordance between the two systems, with a traditional concordance for CO, GEDV, and EVLW of 98.5%, 95.1%, and 97.7% and a polar plot concordance of 100%, 99.8% and 99.8% for CO, GEDV, and EVLW, respectively. Radial limits of agreement for CO, GEDV and EVLW were 0.31 ml/minute, 81 ml and 40 ml, respectively. The precision of GEDV measurements was significantly better using the VolumeView™ algorithm compared to the PiCCO™ algorithm (0.033 (0.03) versus 0.040 (0.03; median (interquartile range), P = 0.000049).

Conclusions

For CO, GEDV, and EVLW, the agreement of both the individual measurements as well as measurements of change showed the interchangeability of the two methods. For the VolumeView method, the higher precision may indicate a more robust GEDV algorithm.

Trial registration

clinicaltrials.gov NCT01405040.

Keywords:
cardiac output; concordance; extravascular lung water; global end diastolic volume; monitoring; transpulmonary thermodilution