Practical impact of a decision support for goal-directed fluid therapy on protocol adherence: a clinical implementation study in patients undergoing major abdominal surgery
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The purpose of this study was to assess the effects of using a real time clinical decision-support system, “Assisted Fluid Management” (AFM), to guide goal-directed fluid therapy (GDFT) during major abdominal surgery. We compared a group of patients managed using the AFM system with a historical cohort of patients (control group) who had been managed using a manual GDFT strategy. Adherence to the protocol was defined as the relative intraoperative time spent with a stroke volume variation (SVV) < 13%. We hypothesised that patients in the AFM group would have more time during surgery with a SVV < 13% compared to the control group. All patients had a radial arterial line connected to a pulse contour analysis monitor and received a 2 ml/kg/h maintenance crystalloid infusion. Additional 250 ml crystalloid boluses were administered whenever measured SVV ≥ 13% in the control group, and when the software suggested a fluid bolus in the AFM group. We compared 46 AFM-guided patients to 38 controls. Patients in the AFM group spent significantly more time during surgery with a SVV < 13% compared to the control group (median 92% [82, 96] vs. 76% [54, 86]; P < 0.0005), and received less fluid overall (1775 ml [1225, 2425] vs. 2350 ml [1825, 3250]; P = 0.010). The incidence of postoperative complications was comparable in the two groups. Implementation of a decision support system for GDFT guidance resulted in a significantly longer period during surgery with a SVV < 13% with a reduced total amount of fluid administered. Trial registration: Clinical Trials.gov (NCT03141411).
KeywordsDecision-assisted resuscitation Cardiac output monitoring Goal-directed therapy
The authors wish to gratefully acknowledge Brian Hipszer, PhD; Distinguished Algorithm Engineer, Critical Care; Edwards Lifesciences (Irvine, California, USA) for software data analysis.
AJ: Designed the study, recruited patients, analysed the data and drafted the manuscript. RA: Recruited patients, collected and analysed the data and edited the manuscript. MP: Recruited patients, collected and analysed the data and edited the manuscript. LVO: Collected and analysed the data and edited the manuscript. TQ: Collected and analysed the data and edited the manuscript. AB: Collected and analysed the data and edited the manuscript. JLV: Analysed the data and edited the manuscript. BI: Collected and analysed the data and edited the manuscript. JR: Designed the study, analysed the data and edited the manuscript. All authors read and approved the final version of the manuscript.
This work was supported by the Department of Anaesthesiology, Erasme Hospital, Brussels.
Compliance with Ethical Standards
Conflict of interest
Alexandre Joosten is a consultant for Edwards Lifesciences (Irvine, CA, USA). Joseph Rinehart is a consultant for Edwards Lifesciences (Irvine, CA, USA) and is also co-founder of Sironis, a compagny developing closed-loop fluid management systems. The other authors declare that they have no conflicts of interest concerning this study.
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