A Comparison of Perioperative Fluid Management Using Invasive Haemodynamical Measurement of Fluid Responsiveness (Aisys GE) and Non-invasive Measurement of Haemodynamics (ClearSight System, Edwards) During Brain Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- fluid balance difference
研究概览
简要总结
The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using invasive measurement SPV/PPV (Aisys GE) and noninvasive haemodynamic measurement (ClarSight, Edwards).
详细描述
The aim of the study is to optimise fluid management and to reduce perioperative risks during brain surgery. Adequate perioperative management guided by hemodynamic monitoring can help to reduce the risk of complications and thus potentially improve outcomes.
This study compares fluid management algorithms based either on invasive detection of fluid responsiveness using pulse pressure variation (PPV) and systolic pressure variation (SPV) values (Aisys GE monitoring system) in group A, or on noninvasive measurement of haemodynamics (stroke volume variation (SVV), cardiac index (CI) and systemic vascular resistance (SVR) values) (ClearSight, Edwards) in group B.
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
- 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
- •Glasgow Coma scale 15
- •ASA Physical Status Classification System I-III
- •planed surgery for brain tumor to 5 hours
- •postoperative awakening
- •sinus rhythm
排除标准
- •NYHA III, IV
- •BMI over 40 in females and over 35 in men
- •awake operation
- •postoperative artificial ventilation
研究组 & 干预措施
Group A invasive haemodynamical measurement
No continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid bolus will be applied in case of protocol defined hypotension according to the value of systolic pressure variation SPV (Aisys GE). The value of SPV (tidal volume 6 ml/kg) above 8% will be used to predict fluid responsiveness. In case of fluid responsiveness, bolus of 2ml/kg of Plasmalyte will be given within 10 minutes. Boluses will be repeated in hypotensive patients if fluid responsiveness persists. Norepinephrine will be used in hypotensive patients without predicted fluid responsiveness.
干预措施: Hemodynamic management based on invasive fluid responsiveness parameters (Procedure)
Group B non-invasive haemodynamical measurement
No continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid management and the use of norepinephrine will follow a protocol based on the values of cardiac index level, systemic vascular resistance and systolic volume variation (SVV) (ClearSight, Edwards).
干预措施: Hemodynamic management based on noninvasive cardiac output and SVV measurement (Procedure)
结局指标
主要结局
fluid balance difference
时间窗: up to 5 hours after start of operation
the difference between fluid intake and output and losses during surgery will be calculated
次要结局
- mean dose of norepinephrine(up to 5 hours after start of operation)
- level of creatinin(24 hours)
- length of postoperative stay(up to 2 month after surgery)
- postoperative lung dysfunction(1 day)
研究者
Dostalova Vlasta, MD, PhD
principal investigator
University Hospital Hradec Kralove