应用容积变异指数的个体化液体管理：一项随机临床试验。

Individualized Fluid Management Using the Pleth Variability Index: A Randomized Clinical Trial.

机构信息

From the Anesthesiology and Critical Care Medicine Department (M.-O.F., S.L., W.G., G.D., J.-L.H.) the INSERM COMETE 1075 Unit, Orthopedic Department, (C.H.) the Biostatistics Department (J.-J.P.), Normandy University, Caen University Hospital, Caen, France Anesthesiology and Critical Care Medicine Department, Lille University Hospital, Lille, France (B.T., M.H.) Anesthesiology and Intensive Care Medicine Department, Hospital of Catholic Institute of Lille, Saint Philibert Hospital, Lomme, France (C.-E.B., V.C.) Anesthesiology and Critical Care Medicine Department, Rouen University Hospital, Charles Nicolle Hospital, Rouen, France (V.C.) Anesthesiology and Critical Care Department, Amiens University Hospital, Amiens, France (D.T., E.L.) Research Unit on Simplified Care of Complex Surgical Patients, Jules Verne University of Picardy, Amiens, France (E.L.). Caen University Hospital, Caen, France Caen University Hospital, Caen, France Amiens Picardie University Hospital, Amiens, France Amiens Picardie University Hospital, Amiens, France Lille University Hospital, Lille, France Lille University Hospital, Lille, France Hospital of Catholic Institute of Lille, Lomme, France Clinical Research Department, Caen University Hospital Clinical Research Department, Caen University Hospital Clinical Research Department, Caen University Hospital Clinical Research Department, Hospital of Catholic Institute of Lille Clinical Research Department, Lille University Hospital Clinical Research Department, Lille University Hospital Clinical Research Department, Amiens Picardie University Hospital.

出版信息

Anesthesiology. 2020 Jul;133(1):31-40. doi: 10.1097/ALN.0000000000003260.

DOI:10.1097/ALN.0000000000003260

PMID:32205547

Abstract

BACKGROUND

The present trial was designed to assess whether individualized strategies of fluid administration using a noninvasive plethysmographic variability index could reduce the postoperative hospital length of stay and morbidity after intermediate-risk surgery.

METHODS

This was a multicenter, randomized, nonblinded parallel-group clinical trial conducted in five hospitals. Adult patients in sinus rhythm having elective orthopedic surgery (knee or hip arthroplasty) under general anesthesia were enrolled. Individualized hemodynamic management aimed to achieve a plethysmographic variability index under 13%, and the standard management strategy aimed to maintain a mean arterial pressure above 65 mmHg during general anesthesia. The primary outcome was the postoperative hospital length of stay decided by surgeons blinded to the group allocation of the patient.

RESULTS

In total, 447 patients were randomized, and 438 were included in the analysis. The mean hospital length of stay ± SD was 6 ± 3 days for the plethysmographic variability index group and 6 ± 3 days for the control group (adjusted difference, 0.0 days; 95% CI, -0.6 to 0.5; P = 0.860); the theoretical postoperative hospital length of stay was 4 ± 2 days for the plethysmographic variability index group and 4 ± 1 days for the control group (P = 0.238). In the plethysmographic variability index and control groups, serious postoperative cardiac complications occurred in 3 of 217 (1%) and 2 of 224 (1%) patients (P = 0.681), acute postoperative renal failure occurred in 9 (4%) and 8 (4%) patients (P = 0.808), the troponin Ic concentration was more than 0.06 μg/l within 5 days postoperatively for 6 (3%) and 5 (2%) patients (P = 0.768), and the postoperative arterial lactate measurements were 1.44 ± 1.01 and 1.43 ± 0.95 mmol/l (P = 0.974), respectively.

CONCLUSIONS

Among intermediate-risk patients having orthopedic surgery with general anesthesia, fluid administration guided by the plethysmographic variability index did not shorten the duration of hospitalization or reduce complications.

摘要

背景

本试验旨在评估使用非侵入性容积描记变异指数的个体化液体管理策略是否可以减少中危手术患者的术后住院时间和发病率。

方法

这是一项在五家医院进行的多中心、随机、非盲平行组临床试验。纳入在全身麻醉下接受择期骨科手术（膝关节或髋关节置换术）的窦性节律成人患者。个体化血流动力学管理旨在使容积描记变异指数低于 13%，标准管理策略旨在维持全身麻醉期间平均动脉压高于 65mmHg。主要结局是由对患者分组情况不知情的外科医生决定的术后住院时间。

结果

共有 447 名患者被随机分配，438 名患者纳入分析。容积描记变异指数组的平均住院时间±标准差为 6±3 天，对照组为 6±3 天（调整差异，0.0 天；95%CI，-0.6 至 0.5；P=0.860）；容积描记变异指数组和对照组的理论术后住院时间分别为 4±2 天和 4±1 天（P=0.238）。在容积描记变异指数组和对照组中，术后发生严重心脏并发症的患者分别为 3 例（1%）和 2 例（1%）（P=0.681），术后发生急性肾功能衰竭的患者分别为 9 例（4%）和 8 例（4%）（P=0.808），术后 5 天内肌钙蛋白 Ic 浓度>0.06μg/l 的患者分别为 6 例（3%）和 5 例（2%）（P=0.768），术后动脉血乳酸测量值分别为 1.44±1.01mmol/l 和 1.43±0.95mmol/l（P=0.974）。