Per Operative Fluid Optimisation Comparison of an Automated Closed-Loop System Versus Current Practice in High Risk Abdominal Surgical Patient. A Prospective, Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Mean indexed cardiac output
研究概览
简要总结
Dynamic parameters like pulse pressure variation have been shown to be accurate predictors of fluid responsiveness. Hemodynamic optimization based on fluid management and stroke volume optimization have been shown to improve patient outcomes, especially for moderate and high risk abdominal surgical patients. A novel closed-loop fluid administration system based on multi-parameter hemodynamic monitoring have been described recently. This prospective, randomized, surgeon and patient blinded study aims at comparing the cardiac output provided by either this closed-loop system or the anesthesiologist team in high-rish surgical patient elected for abdominal surgery at Pierre Bénite University Hospital, Hospices Civils of Lyon, France. Primary endpoint is the mean indexed cardiac output during surgery per group. We will also compare hemodynamic parameter (cardiac output, stroke volume, blood pressure heart rate…) and patient's outcomes (morbidity, mortality, transfusion rate, hospital length of stay) between groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective major abdominal surgery
- •Patient physical status ASA 2-4
- •General anesthesia with positive pressure ventilation
- •High risk surgical patient with a per operative Vigileo® cardiac output monitoring decided a priori.
排除标准
- •Pregnant female
- •Intraoperative hyperthermic chemotherapy procedure
- •Patient physical status ASA more than 4
- •Patient with allergy to hydroxyethyl starch
- •Cardiac arrhythmia
- •ventilation with tidal volume inferior 7mL/Kg
研究组 & 干预措施
Automated fluid management system (Closed-loop system)
cardiac output Vigileo® (Edwards Lifesciences) monitoring is connected to the closed loop system that will automatically provide per operative fluid bolus to optimize cardiac output by automated detection of fluid responsiveness state.
干预措施: Closed loop automated System (LIR®: learning intravenous resuscitator) (Device)
Current practice manual fluid management
cardiac output Vigileo® (Edwards Lifesciences) monitoring will be used to help the anesthesiologist team to detect fluid responsiveness state for the manual fluid management optimization
干预措施: manual current practice by anesthesiologist team (Device)
结局指标
主要结局
Mean indexed cardiac output
时间窗: J1 to J12 (Within the surgical hospital length of stay)
次要结局
- per operative hemodynamic parameter(J1 (per operative time))
- Per operative fluid administration(J1 (per operative))
- Hospital length of stay(J1 to J12)
- Occurrence of a adverse event after surgery(an expected average of 12 days)
- Occurrence of a death whatever the cause(an expected average of 12 days)
