Coeckelenbergh Sean, Entzeroth Marguerite, Van der Linden Philippe, Flick Moritz, Soucy-Proulx Maxim, Alexander Brenton, Rinehart Joseph, Grogan Tristan, Cannesson Maxime, Vincent Jean-Louis, Vicaut Eric, Duranteau Jacques, Joosten Alexandre
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.
Outcomes Research Consortium, Cleveland, Ohio.
Anesth Analg. 2025 May 1;140(5):1149-1158. doi: 10.1213/ANE.0000000000007097.
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.
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.
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).
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.
目标导向液体治疗(GDFT)方案的实施率仍然较低。由于工作量大以及实施过程需要专注,麻醉医生对方案的依从性往往不理想。辅助液体管理(AFM)系统是一种新型决策支持工具,旨在帮助临床医生应用GDFT方案。该系统预测液体反应性的能力优于麻醉医生,并且在手术期间能实现更高的每搏输出量(SV)和心脏指数值。我们检验了这样一个假设:与标准GDFT策略相比,AFM引导的GDFT策略也会与更好的舌下微血管血流相关。
这项双中心、平行、双臂、前瞻性、随机对照、患者和评估者双盲的优效性研究纳入了所有连续接受高风险腹部手术且需要动脉导管和未校准SV监测的患者。采用标准GDFT的患者接受手动滴定液体负荷以优化SV,而采用AFM引导的GDFT策略的患者根据AFM软件的建议接受液体负荷。在所有患者中,液体负荷标准化为每250 mL进行滴定,并使用血管升压药维持平均动脉压>70 mmHg。主要结局(每个患者在4个术中时间点的术中微血管血流指数(MFI)平均值)采用Mann-Whitney U检验进行分析,并使用Bootstrap百分位数法(1000次重复)估计组间中位数差异及95%置信区间来评估治疗效果。次要结局包括SV、心脏指数、液体总量、其他微循环变量和术后乳酸水平。
在7个月的时间里共纳入了86例患者。采用AFM的患者的主要结局显著高于采用标准GDFT的患者(中位数[Q1-Q3]:2.89[2.84-2.94])(2.59[2.38-2.78]分,中位数差异0.30;95%置信区间[CI],0.19-0.49;P<.001)。采用AFM引导的GDFT的患者的心脏指数和每搏量指数更高(3.2±0.5 vs 2.7±0.7 l·min-1·m-2;P=.001和42[35-47] vs 36[32-43] mL·m-2;P=.018),且手术结束时动脉血乳酸浓度低于采用标准GDFT策略的患者(2.1[1.5-3.1] vs 2.9[2.1-3.9] mmol·L-1;P=.026)。采用AFM的患者接受的液体量更多,但去甲肾上腺素的用量比采用标准GDFT的患者少3倍(P<.001)。
与使用标准GDFT策略相比,使用AFM引导的GDFT策略可使手术期间舌下微血管血流更高。未来有必要进行试验以得出能改变临床实践的确切建议。