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
- 2
- 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
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)
- length of postoperative stay(up to 2 month after surgery)
- level of creatinin(24 hours)
- postoperative lung dysfunction(1 day)
研究者
Dostalova Vlasta, MD, PhD
principal investigator
University Hospital Hradec Kralove