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Randomized Controlled Trial Multicenter Study
Individualized Fluid Management Using the Pleth Variability Index: A Randomized Clinical Trial.
- Marc-Olivier Fischer, Sandrine Lemoine, Benoît Tavernier, Chems-Eddine Bouchakour, Vincent Colas, Marion Houard, William Greub, Georges Daccache, Christophe Hulet, Vincent Compère, Diane Taing, Emmanuel Lorne, Jean-Jacques Parienti, Jean-Luc Hanouz, and Optimization using the Pleth Variability Index (OPVI) Trial Group.
- 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.
- Anesthesiology. 2020 Jul 1; 133 (1): 31-40.
BackgroundThe 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.MethodsThis 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.ResultsIn 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.ConclusionsAmong 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.
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