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Randomized Controlled Trial
. 2010;14(1):R18.
doi: 10.1186/cc8875. Epub 2010 Feb 15.

Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial

Affiliations
Randomized Controlled Trial

Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial

Jochen Mayer et al. Crit Care. 2010.

Abstract

Introduction: Several studies have shown that goal-directed hemodynamic and fluid optimization may result in improved outcome. However, the methods used were either invasive or had other limitations. The aim of this study was to perform intraoperative goal-directed therapy with a minimally invasive, easy to use device (FloTrac/Vigileo), and to evaluate possible improvements in patient outcome determined by the duration of hospital stay and the incidence of complications compared to a standard management protocol.

Methods: In this randomized, controlled trial 60 high-risk patients scheduled for major abdominal surgery were included. Patients were allocated into either an enhanced hemodynamic monitoring group using a cardiac index based intraoperative optimization protocol (FloTrac/Vigileo device, GDT-group, n = 30) or a standard management group (Control-group, n = 30), based on standard monitoring data.

Results: The median duration of hospital stay was significantly reduced in the GDT-group with 15 (12 - 17.75) days versus 19 (14 - 23.5) days (P = 0.006) and fewer patients developed complications than in the Control-group [6 patients (20%) versus 15 patients (50%), P = 0.03]. The total number of complications was reduced in the GDT-group (17 versus 49 complications, P = 0.001).

Conclusions: In high-risk patients undergoing major abdominal surgery, implementation of an intraoperative goal-directed hemodynamic optimization protocol using the FloTrac/Vigileo device was associated with a reduced length of hospital stay and a lower incidence of complications compared to a standard management protocol.

Clinical trial registration information: Unique identifier: NCT00549419.

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Figures

Figure 1
Figure 1
Enhanced hemodynamic monitoring protocol with FloTrac/Vigileo. CI, cardiac index; MAP, mean arterial pressure; SVI, stroke volume index; SVV, stroke volume variation.
Figure 2
Figure 2
Standard care protocol. MAP, mean arterial pressure; CVP, central venous pressure.
Figure 3
Figure 3
Patient flow throughout the study.
Figure 4
Figure 4
Kaplan-Meier survival analysis of length of hospital stay. The dotted line represents the goal-directed therapy (GDT) group.

Comment in

  • A plea for balanced reporting.
    Singer M. Singer M. Crit Care. 2010;14(2):414. doi: 10.1186/cc8942. Epub 2010 Apr 20. Crit Care. 2010. PMID: 20429962 Free PMC article.

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