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

Mayer J, Boldt J, Mengistu AM, Röhm KD, Suttner S - Crit Care (2010)

Bottom Line: Several studies have shown that goal-directed hemodynamic and fluid optimization may result in improved outcome.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).

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Anesthesiology and Intensive Care Medicine, Klinikum Ludwigshafen, Bremserstrasse, 79, 67063 Ludwigshafen, Germany. j-mayer@gmx.de

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.

Show MeSH
Standard care protocol. MAP, mean arterial pressure; CVP, central venous pressure.
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Figure 2: Standard care protocol. MAP, mean arterial pressure; CVP, central venous pressure.

Mentions: In the control group, MAP was kept between 65 and 90 mmHg, CVP between 8 and 12 mmHg and urinary output more than 0.5 mL kg-1 h-1. The GDT-group patients received enhanced hemodynamic monitoring with the FloTrac/Vigileo device (Edwards Lifesciences, Irvine, CA, USA) and an attempted cardiac index (CI) of at least 2.5 L·min-1·m-2. The arterial line was connected to the Vigileo monitor (software version 1.14; Edwards Lifesciences, Irvine, CA, USA) via the FloTrac pressure transducer and all intravascular pressure measurements were referenced to mid-axillary line level. The shape of the arterial curve was checked visually for damping throughout the study period. CI, stroke volume index (SVI), as an indicator for fluid status, and stroke volume variation, (SVV) as an indicator for fluid responsiveness during mechanical ventilation and sinus rhythm, were continuously measured. Details of the protocols for both standard and enhanced hemodynamic monitoring are summarized in Figures 1 and 2. Side effects of GDT (e.g. tachycardia during dobutamine infusion) were not acceptable and as soon as they developed further optimization attempts were ceased and patients were kept at the best possible level. Blood loss was substituted with fluids according to the protocols and a hemoglobin value below 8 mg dL-1 was considered to be a trigger for transfusion of packed red blood cells.


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

Mayer J, Boldt J, Mengistu AM, Röhm KD, Suttner S - Crit Care (2010)

Standard care protocol. MAP, mean arterial pressure; CVP, central venous pressure.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2875533&req=5

Figure 2: Standard care protocol. MAP, mean arterial pressure; CVP, central venous pressure.
Mentions: In the control group, MAP was kept between 65 and 90 mmHg, CVP between 8 and 12 mmHg and urinary output more than 0.5 mL kg-1 h-1. The GDT-group patients received enhanced hemodynamic monitoring with the FloTrac/Vigileo device (Edwards Lifesciences, Irvine, CA, USA) and an attempted cardiac index (CI) of at least 2.5 L·min-1·m-2. The arterial line was connected to the Vigileo monitor (software version 1.14; Edwards Lifesciences, Irvine, CA, USA) via the FloTrac pressure transducer and all intravascular pressure measurements were referenced to mid-axillary line level. The shape of the arterial curve was checked visually for damping throughout the study period. CI, stroke volume index (SVI), as an indicator for fluid status, and stroke volume variation, (SVV) as an indicator for fluid responsiveness during mechanical ventilation and sinus rhythm, were continuously measured. Details of the protocols for both standard and enhanced hemodynamic monitoring are summarized in Figures 1 and 2. Side effects of GDT (e.g. tachycardia during dobutamine infusion) were not acceptable and as soon as they developed further optimization attempts were ceased and patients were kept at the best possible level. Blood loss was substituted with fluids according to the protocols and a hemoglobin value below 8 mg dL-1 was considered to be a trigger for transfusion of packed red blood cells.

Bottom Line: Several studies have shown that goal-directed hemodynamic and fluid optimization may result in improved outcome.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).

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Anesthesiology and Intensive Care Medicine, Klinikum Ludwigshafen, Bremserstrasse, 79, 67063 Ludwigshafen, Germany. j-mayer@gmx.de

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.

Show MeSH