Lilot Marc, Bellon Amandine, Gueugnon Marine, Laplace Marie-Christine, Baffeleuf Bruno, Hacquard Pauline, Barthomeuf Felicie, Parent Camille, Tran Thomas, Soubirou Jean-Luc, Robinson Philip, Bouvet Lionel, Vassal Olivia, Lehot Jean-Jacques, Piriou Vincent
Département d'anesthésie, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, 59 Boulevard Pinel, 69500, Bron, France.
Centre Lyonnais d'Enseignement par Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, Lyon, France.
J Clin Monit Comput. 2018 Dec;32(6):993-1003. doi: 10.1007/s10877-018-0106-7. Epub 2018 Jan 27.
An intraoperative automated closed-loop system for goal-directed fluid therapy has been successfully tested in silico, in vivo and in a clinical case-control matching. This trial compared intraoperative cardiac output (CO) in patients managed with this closed-loop system versus usual practice in an academic medical center. The closed-loop system was connected to a CO monitoring system and delivered automated colloid fluid boluses. Moderate to high-risk abdominal surgical patients were randomized either to the closed-loop or the manual group. Intraoperative final CO was the primary endpoint. Secondary endpoints were intraoperative overall mean cardiac index (CI), increase from initial to final CI, intraoperative fluid volume and postoperative outcomes. From January 2014 to November 2015, 46 patients were randomized. There was a lower initial CI (2.06 vs. 2.51 l min m, p = 0.042) in the closed-loop compared to the control group. No difference in final CO and in overall mean intraoperative CI was observed between groups. A significant relative increase from initial to final CI values was observed in the closed-loop but not the control group (+ 28.6%, p = 0.006 vs. + 1.2%, p = 0.843). No difference was found for intraoperative fluid management and postoperative outcomes between groups. There was no significant impact on the primary study endpoint, but this was found in a context of unexpected lower initial CI in the closed-loop group.Trial registry number ID-RCB/EudraCT: 2013-A00770-45. ClinicalTrials.gov Identifier NCT01950845, date of registration: 17 September 2013.
一种用于目标导向液体治疗的术中自动闭环系统已在计算机模拟、体内实验和临床病例对照匹配中成功测试。本试验比较了在一所学术医疗中心使用该闭环系统管理的患者与常规治疗患者的术中心输出量（CO）。闭环系统连接到CO监测系统，并自动输注胶体液 bolus。中度至高度风险的腹部手术患者被随机分为闭环组或手动组。术中最终CO是主要终点。次要终点包括术中总体平均心脏指数（CI）、从初始CI到最终CI的增加、术中液体量和术后结果。2014年1月至2015年11月，46例患者被随机分组。与对照组相比，闭环组的初始CI较低（2.06 vs. 2.51 l min m，p = 0.042）。两组之间在最终CO和术中总体平均CI方面未观察到差异。在闭环组中观察到从初始CI值到最终CI值有显著的相对增加，而对照组没有（+28.6%，p = 0.006 vs. +1.2%，p = 0.843）。两组之间在术中液体管理和术后结果方面未发现差异。对主要研究终点没有显著影响，但这是在闭环组初始CI意外较低的情况下发现的。试验注册号ID-RCB/EudraCT：2013-A00770-45。ClinicalTrials.gov标识符NCT01950845，注册日期：2013年9月17日。
