Assisted Fluid Management and Sublingual Microvascular Flow During High-Risk Abdominal Surgery: A Randomized Controlled Trial

Sean Coeckelenbergh; Marguerite Entzeroth; Philippe Van der Linden; Moritz Flick; Maxim Soucy-Proulx; Brenton Alexander; Joseph Rinehart; Tristan Grogan; Maxime Cannesson; Jean-Louis Vincent; Eric Vicaut; Jacques Duranteau; Alexandre Joosten

doi:10.1213/ANE.0000000000007097

Assisted Fluid Management and Sublingual Microvascular Flow During High-Risk Abdominal Surgery: A Randomized Controlled Trial

Anesth Analg. 2024 Aug 8. doi: 10.1213/ANE.0000000000007097. Online ahead of print.

Authors

Affiliations

¹ From the Department of Anaesthesiology and Intensive Care, Hôpitaux Universitaires Paris-Saclay, Université Paris-Saclay, Hôpital Paul-Brousse, Assistance Publique Hôpitaux de Paris (AP-HP), Villejuif, France.
² Outcomes Research Consortium, Cleveland, Ohio.
³ Université Libre de Bruxelles, Brussels, Belgium.
⁴ Department of Anaesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
⁵ Department of Anaesthesiology & Perioperative Care, University of California San Diego, La Jolla, California.
⁶ Department of Anaesthesiology & Perioperative Care, University of California Irvine, California, Irvine, California.
⁷ Department of Medicine Statistics Core, David Geffen School of Medicine, University of California Los Angeles, California, Los Angeles, California.
⁸ Department of Anaesthesiology & Perioperative Medicine, David Geffen School of Medicine, University of California Los Angeles, California, Los Angeles, California.
⁹ Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.
¹⁰ Unité de Recherche Clinique, Lariboisière University Hospital, Paris 7 Diderot University, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.

PMID: 39116013
DOI: 10.1213/ANE.0000000000007097

Abstract

Background: Implementation of goal-directed fluid therapy (GDFT) protocols remains low. Protocol compliance among anesthesiologists tends to be suboptimal owing to the high workload and the attention required for implementation. The assisted fluid management (AFM) system is a novel decision support tool designed to help clinicians apply GDFT protocols. This system predicts fluid responsiveness better than anesthesia practitioners do and achieves higher stroke volume (SV) and cardiac index values during surgery. We tested the hypothesis that an AFM-guided GDFT strategy would also be associated with better sublingual microvascular flow compared to a standard GDFT strategy.

Methods: This bicenter, parallel, 2-arm, prospective, randomized controlled, patient and assessor-blinded, superiority study considered for inclusion all consecutive patients undergoing high-risk abdominal surgery who required an arterial catheter and uncalibrated SV monitoring. Patients having standard GDFT received manual titration of fluid challenges to optimize SV while patients having an AFM-guided GDFT strategy received fluid challenges based on recommendations from the AFM software. In all patients, fluid challenges were standardized and titrated per 250 mL and vasopressors were administered to maintain a mean arterial pressure >70 mm Hg. The primary outcome (average of each patient's intraoperative microvascular flow index (MFI) across 4 intraoperative time points) was analyzed using a Mann-Whitney U test and the treatment effect was estimated with a median difference between groups with a 95% confidence interval estimated using the bootstrap percentile method (with 1000 replications). Secondary outcomes included SV, cardiac index, total amount of fluid, other microcirculatory variables, and postoperative lactate.

Results: A total of 86 patients were enrolled over a 7-month period. The primary outcome was significantly higher in patients with AFM (median [Q1-Q3]: 2.89 [2.84-2.94]) versus those having standard GDFT (2.59 [2.38-2.78] points, median difference 0.30; 95% confidence interval [CI], 0.19-0.49; P < .001). Cardiac index and SVI were higher (3.2 ± 0.5 vs 2.7 ± 0.7 l.min-1.m-2; P = .001 and 42 [35-47] vs 36 [32-43] mL.m-2; P = .018) and arterial lactate concentration was lower at the end of the surgery in patients having AFM-guided GDFT (2.1 [1.5-3.1] vs 2.9 [2.1-3.9] mmol.L-1; P = .026) than patients having standard GDFT strategy. Patients having AFM received a higher fluid volume but 3 times less norepinephrine than those receiving standard GDFT (P < .001).

Conclusions: Use of an AFM-guided GDFT strategy resulted in higher sublingual microvascular flow during surgery compared to use of a standard GDFT strategy. Future trials are necessary to make conclusive recommendations that will change clinical practice.

Trial registration: ClinicalTrials.gov NCT03965702.

Associated data

ClinicalTrials.gov/NCT03965702