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, Joachim Boldt, Andinet M Mengistu, Kerstin D Röhm, Stefan Suttner, Jochen Mayer, Joachim Boldt, Andinet M Mengistu, Kerstin D Röhm, Stefan Suttner

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.

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.

References

    1. Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennet ED. Early goal-directed therapy after major surgery reduces complications and hospital stay. A randomised, controlled trial. Crit Care. 2005;9:R687–R693. doi: 10.1186/cc3887.
    1. Bundgaard-Nielsen M, Holte K, Secher NH, Kehlet H. Monitoring of peri-operative fluid administration by individualized goal-directed therapy. Acta Anaesthesiol Scand. 2007;51:331–340. doi: 10.1111/j.1399-6576.2006.01221.x.
    1. Donati A, Loggi S, Preiser JC, Orsetti G, Münch C, Gabbanelli V, Pelaia P, Pietropaoli P. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest. 2007;132:1817–1824. doi: 10.1378/chest.07-0621.
    1. Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009;103:637–646. doi: 10.1093/bja/aep279.
    1. Boyd O, Grounds RM, Bennett ED. A randomized clinical trial of the effect of deliberate perioperative increase of oxygen delivery on mortality in high-risk surgical patients. JAMA. 1993;270:2699–2707. doi: 10.1001/jama.270.22.2699.
    1. Harvey S, Harrison DA, Singer M, Ashcroft J, Jones CM, Elbourne D, Brampton W, Williams D, Young D, Rowan K. PAC-Man study collaboration. Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomized controlled trial. Lancet. 2005;366:472–477. doi: 10.1016/S0140-6736(05)67061-4.
    1. Wilson J, Woods I, Fawcett J, Whall R, Dibb W, Morris C, McManus E. Reducing the risk of major elective surgery: randomised controlled trial of preoperative optimisation of oxygen delivery. BMJ. 1999;318:1099–1103.
    1. Lobo SM, Salgado PF, Castillo VG, Borim AA, Polachini CA, Palchetti JC, Brienzi SL, de Oliveira GG. Effects of maximizing oxygen delivery on morbidity and mortality in high-risk surgical patients. Crit Care Med. 2000;28:3396–3404. doi: 10.1097/00003246-200010000-00003.
    1. Conway DH, Mayall R, Abdul-Latif MS, Gilligan S, Tackaberry C. Randomized controlled clinical trial investigating the influence of intravenous fluid titration using oesophageal Doppler monitoring during bowel surgery. Anaesthesia. 2002;57:845–849. doi: 10.1046/j.1365-2044.2002.02708.x.
    1. Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002;97:820–826. doi: 10.1097/00000542-200210000-00012.
    1. Noblett SE, Snowden CP, Shenton BK, Horgan AF. Randomized clinical trial assessing the effect of Doppler-optimized fluid management on outcome after elective colorectal resection. Br J Surg. 2006;93:1069–1076. doi: 10.1002/bjs.5454.
    1. Dark PM, Singer M. The validity of trans-esophageal doppler ultrasonography as a measure of cardiac output in critically ill adults. Intensive Care Med. 2004;30:2060–2066. doi: 10.1007/s00134-004-2430-2.
    1. Lefrant JY, Bruelle P, Aya AG, Saïssi G, Dauzat M, de La Coussaye JE, Eledjam JJ. Training is required to improve the reliability of esophageal doppler to measure cardiac output in critically ill patients. Intensive Care Med. 1998;24:347–352. doi: 10.1007/s001340050578.
    1. Jaeggi P, Hofer CK, Klaghofer R, Fodor P, Genoni M, Zollinger A. Measurement of cardiac output after cardiac surgery by a new transesophageal Doppler device. J Cardiothorac Vasc Anesth. 2003;17:217–220. doi: 10.1053/jcan.2003.50.
    1. Manecke GR. Cardiac output from the arterial catheter: deceptively simple. J Cardiothorac Vasc Anesth. 2007;21:629–631. doi: 10.1053/j.jvca.2007.07.001.
    1. Mayer J, Boldt J, Wolf MW, Lang J, Suttner S. Cardiac output derived from arterial pressure waveform analysis in patients undergoing cardiac surgery: validity of a second generation device. Anesth Analg. 2008;106:867–872. doi: 10.1213/ane.0b013e318161964d.
    1. Prasser C, Trabold B, Schwab A, Keyl C, Ziegler S, Wiesenack C. Evaluation of an improved algorithm for arterial pressure-based cardiac output assessment without external calibration. Intensive Care Med. 2007;33:2223–2225. doi: 10.1007/s00134-007-0859-9.
    1. Mayer J, Boldt J, Beschmann R, Stephan A, Suttner S. Uncalibrated arterial pressure waveform analysis for less-invasive cardiac output determination in obese patients undergoing cardiac surgery. Br J Anaesth. 2009;103:185–190. doi: 10.1093/bja/aep133.
    1. Hofer CK, Senn A, Weibel L, Zollinger A. Assessment of stroke volume variation for prediction of fluid responsiveness using the modified FloTrac and PiCCOplus system. Crit Care. 2008;12:R82. doi: 10.1186/cc6933.
    1. ASA physical status classification system.
    1. Lee TH, Marcantonio ER, Mangione CM, Thomas EJ, Polanczyk CA, Cook EF, Sugarbaker DJ, Donaldson MC, Poss R, Ho KK, Ludwig LE, Pedan A, Goldman L. Derivation and prospective validation of a simple index for prediciton of cardiac risk of major noncardiac surgery. Circulation. 1999;100:1043–1049.
    1. Copeland GP. The POSSUM system of surgical audit. Arch Surg. 2002;137:15–19. doi: 10.1001/archsurg.137.1.15.
    1. Shoemaker WC. Cardiorespiratory patterns of surviving and nonsurviving postoperative patients. Surg Gynecol Obstet. 1972;134:810–814.
    1. Shoemaker WC, Appel PL, Kram HB, Waxman K, Lee TS. Prospective trial of supranormal values of survivors as therapeutic goals in high-risk surgical patients. Chest. 1988;94:1176–1186. doi: 10.1378/chest.94.6.1176.
    1. Lopes MR, Oliveira MA, Pereira VO, Lemos IP, Auler JO Jr, Michard F. Goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery: a pilot randomized controlled trial. Crit Care. 2007;11:R100. doi: 10.1186/cc6117.
    1. Abbas SM, Hill AG. Systematic review of the literature for the use of oesophageal Doppler monitor for fluid replacement in major abdominal surgery. Anaesthesia. 2008;63:44–51. doi: 10.1111/j.1365-2044.2007.05233.x.
    1. Poeze M, Greve JW, Ramsay G. Meta-analysis of hemodynamic optimization: relationship to methodological quality. Crit Care. 2005;9:R771–779. doi: 10.1186/cc3902.
    1. Cecconi M, Dawson D, Grounds RM, Rhodes A. Lithium dilution cardiac output measurement in the critically ill patient: determination of precision of the technique. Intensive Care Med. 2009;35:498–504. doi: 10.1007/s00134-008-1292-4.
    1. Costa MG, Della Rocca G, Chiarandini P, Mattelig S, Pompei L, Sainz Barriga M, Reynolds T, Cecconi M, Pietropaoli P. Continuous and intermittent cardiac output measurement in hyperdynamic conditions: pulmonary artery catheter vs. lithium dilution technique. Intensive Care Med. 2008;34:257–263. doi: 10.1007/s00134-007-0878-6.
    1. Wakeling HG, McFall MR, Jenkins CS, Woods WG, Miles WF, Barclay GR, Fleming SC. Intraoperative oesophageal Doppler guided fluid management shortens postoperative hospital stay after major bowel surgery. Br J Anaesth. 2005;95:634–642. doi: 10.1093/bja/aei223.
    1. Kimberger O, Arnberger M, Brandt S, Plock J, Sigurdsson GH, Kurz A, Hiltebrand L. Goal-directed colloid administration improves the microcirculation of healthy and perianastomotic colon. Anesthesiology. 2009;110:496–504. doi: 10.1097/ALN.0b013e31819841f6.
    1. Spahn DR, Chassot PG. CON: Fluid restriction for cardiac patients during major noncardiac surgery should be replaced by goal-directed intravascular fluid administration. Anesth Analg. 2006;102:344–346. doi: 10.1213/01.ane.0000196511.48033.0b.
    1. Eleftheriadis S, Galatoudis Z, Didilis V, Bougioukas I, Schön J, Heinze H, Berger KU, Heringlake M. Variations in arterial blood pressure are associated with parallel changes in FlowTrac/Vigileo®-derived cardiac output measurements: a prospective comparison study. Crit Care. 2009;13:R179. doi: 10.1186/cc8161.

Source: PubMed

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