Clinical Trial
Journal Article
Multicenter Study
Validation Study
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Performance of a new pulse contour method for continuous cardiac output monitoring: validation in critically ill patients.

BACKGROUND: A new calibrated pulse wave analysis method (VolumeView™/EV1000™, Edwards Lifesciences, Irvine, CA, USA) has been developed to continuously monitor cardiac output (CO). The aim of this study was to compare the performance of the VolumeView method, and of the PiCCO2™ pulse contour method (Pulsion Medical Systems, Munich, Germany), with reference transpulmonary thermodilution (TPTD) CO measurements.

METHODS: This was a prospective, multicentre observational study performed in the surgical and interdisciplinary intensive care units of four tertiary hospitals. Seventy-two critically ill patients were monitored with a central venous catheter, and a thermistor-tipped femoral arterial VolumeView™ catheter connected to the EV1000™ monitor. After initial calibration by TPTD CO was continuously assessed using the VolumeView-CCO software (CCO(VolumeView)) during a 72 h period. TPTD was performed in order to obtain reference CO values (COREF). TPTD and arterial wave signals were transmitted to a PiCCO2™ monitor in order to obtain CCO(PiCCO) values. CCO(VolumeView) and CCO(PiCCO) were recorded over a 5 min interval before assessment of CO(TPTD). Bland-Altman analysis, %(errors), and concordance (trend analysis) were calculated.

RESULTS: A total of 338 matched sets of data were available for comparison. Bias for CCO(VolumeView)-CO(REF) was -0.07 litre min(-1) and for CCO(PiCCO)-CO(REF) +0.03 litre min(-1). Corresponding limits of agreement were 2.00 and 2.48 litre min(-1) (P<0.01), %(errors) 29 and 37%, respectively. Trending capabilities were comparable for both techniques.

CONCLUSIONS: The performance of the new VolumeView™-CCO method is as reliable as the PiCCO2™-CCO pulse wave analysis in critically ill patients. However, an improved precision was observed with the VolumeView™ technique. CLINICALTRIALS.GOV IDENTIFIER: NCT01405040.

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