Comparative Noninvasive Continuous Cardiac Output by the Clearsight With Invasive Monitoring by Pulsioflex in Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Stroke Ejection Volume (SEV) measure by ClearSight®
研究概览
简要总结
In high-risk patients, it is now recommended to guide the intraoperative volume replacement via the stroke volume.
Today, the most commonly used technique for estimating the stroke volume is the arterial waveform analysis in the radial artery. This technique has the disadvantage of being invasive and increasing the time dedicated to anesthesia during the surgery.
The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has developed a continuous monitoring technology and non-invasive arterial pressure, cardiac output and stroke volume using a digital sensor (ClearSight®). The continuous monitoring of blood pressure by this technique was validated in cardiothoracic surgery but studies about monitoring cardiac output or stroke volume are inconclusive and contradictory.
The objective of this study is to compare the use of non-invasive monitoring of stroke volume by Clearsight® with the arterial waveform analysis in the radial artery by Pulsioflex® in major surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 scheduled to undergo major surgery
- •Patients monitored by a Pulsioflex® device
排除标准
- •Patients with heart rhythm disorder
- •Patients with Raynaud's disease or vasculitis
- •Emergency surgery
- •Significant edema fingers
结局指标
主要结局
Stroke Ejection Volume (SEV) measure by ClearSight®
时间窗: 24 hours
Stroke Ejection Volume (SEV) measure by Pulsioflex®
时间窗: 24 hours
次要结局
- Cardiac Output (CO) measure by Pulsioflex®(24 hours)
- Cardiac Output (CO) measure by ClearSight®(24 hours)
- Stroke Ejection Volume Variations (SVV) measure by ClearSight®(24 hours)
- Stroke Ejection Volume Variations (SVV) measure by Pulsioflex®(24 hours)