Prospective, Monocentric Pilot Study for the Validation of Stroke Volume by Use of NexFin in Comparison to Different Hemodynamic Monitoring Procedures (Picco2, FloTrac and TEE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- stroke volume
研究概览
简要总结
Main hypothesis: there is no difference between stroke volume measurements recorded by a new noninvasive finger cuff system (NexFin) and invasive hemodynamic monitoring systems as Picco2-system, FloTrac and transesophageal echocardiography
详细描述
In high risc patients undergoing orthopedic surgery an extended cardiopulmonary observation improves patients safety and postoperative outcome. Therefore invasive procedures as Picco2-system, FloTrac and transesophageal echocardiography (tee) have the advantage to measure or calculate stroke volume. Disadvantage of this treatments is the need for a vascular access with all its complications.
In this study the stroke volume measured by a new noninvasive finger cuff system (NexFin) should be validated in comparison to invasive hemodynamic monitoring systems as Picco2-system, FloTrac and tee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •patients undergoing orthopedic surgery with need for invasive blood pressure measurements
- •age ≥ 18 years
- •signed informed consent
- •no participation on another interventional study
排除标准
- •refusal of participation
- •patients who are not able to sign informed consent
- •atrial fibrillation with arrhythmia
- •peripheral arterial disease > Fontain IIa
- •scleroderma
- •presence of an arterio-venous shunt on upper limb
- •contraindication for femoral arterial vascular access
- •contraindication for transesophageal echocardiography
- •stage III heart valve defects
- •shunt heart defects
- •solitary regional anaesthesia
- •pregnant or breastfeeding women
结局指标
主要结局
stroke volume
时间窗: preinduction, 3 and 15 minutes after induction, before and after a volume challenge, 30 minutes after induction, end of surgery
次要结局
- mean arterial pressure(preinduction, 3 and 15 minutes after induction, before and after volume challenge, 30 minutes after induction, end of surgery)
研究者
Michael Sander
Vice Chair
Charite University, Berlin, Germany