Perioperative Fluid Therapy Optimization in Spinal Surgery Using Non-invasive Measurement of Haemodynamics (ClearSight System, Edwards); a Comparison to Standard Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- intraoperative fluid balance
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 continuous noninvasive cardiac output measurement with standard perioperative fluid management.
详细描述
The aim of the study is to optimise fluid managemet and to reduce perioperative risks during spinal procedures in prone position. Adequate perioperative management guided by hemodynamic monitoring can help to reduce the risk of complications and thus potentially improve outcomes.
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 65 Years（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 spinal surgery to 3 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
intraoperative fluid balance
时间窗: 5 hours
the difference between fluid intake and output and losses during surgery
次要结局
- level of creatinine(24 hours)
- mean dose of norepinephrine(5 hours)
- pooperative lung dysfunction(24 hours)
- the length of postoperative stay(till 2 months after surgery)
研究者
Dostalova Vlasta, MD, PhD
Principal Investigator
University Hospital Hradec Kralove