Automated Administration of Fluid Administration Thanks to Hemodynamic Parameters and Cardiac Output During General Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Mean cardiac output index during the surgery
研究概览
简要总结
The investigators want to test during anesthesia the feasibility of a closed-loop automated fluid replacement system using cardiac output monitoring as the input value.
详细描述
The optimization of the cardiac output is an important goal during anesthesia to decrease the postoperative morbidity, mortality and the care costs.
We want to test if the closed-loop fluid administration is feasible.
Two groups will be compared. In all cases:
- anesthesia will be provided by a closed-loop which aim is to maintain bispectral index between 40 and 60 using propofol and remifentanil. This method permits to have similar depths of anesthesia in all cases.
- cardiac output will be continuously monitored by LidCO. In one group, fluid replacement is decided by the physician; in the other, fluid replacement is automated using a closed-loop system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18-75 years
- •Scheduled for abdominal surgery under general anesthesia and requiring an invasive arterial blood pressure monitoring
- •Consenting to participate in the study
排除标准
- •Pregnant, breast feeding women
- •Pacemaker
- •Psychiatric disease, dementia, brain disease
- •Contraindication to hydroxyethyl starch
- •Inability to measure pulse pressure variability : arrhythmia, spontaneous breathing, or tidal volume < 7 ml/Kg
研究组 & 干预措施
Open loop
fluid replacement (hydroxyethyl starch 130/0.4) is decided by the physicians according to continuous cardiac output measured by LidCO rapid device
干预措施: Open loop (Drug)
Closed-loop
Fluid replacement is automated. An algorithm has been developed ; the input value is continuous cardiac output measured by LidCO rapid device; the computer steers iv infusion of hydroxyethyl starch 130/0.4.
干预措施: Closed-loop (Device)
结局指标
主要结局
Mean cardiac output index during the surgery
时间窗: One day after anesthesia
次要结局
- cardiac index during the surgery(One day after anesthesia)
- arterial hypertension(One day after anesthesia)
- Dysfunction of the closed-loop fluid device(One day after anesthesia)
- Time before reaching maximizing cardiac output(One day after anesthesia)
- Volume of fluid replacement during surgery(One day after anesthesia)