NCT02040948已完成不适用
Accuracy of Pulse Pressure Variation (Nexfin) and of Pleth Variability Index (Radical 7) to Predict the Response to a Fluid Challenge: Comparison With the Reference Method (Measurement of Stroke Volume by Esophageal Doppler)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Ability of Pleth Variability Index and of Pulse Pressure Variation to detect the response to a fluid challenge
研究概览
简要总结
The aim of this study is to compare the accuracy of Pleth Variability Index (Radical 7 device) and of Pulse Pressure Variation (Nexfin device) with the Doppler measurement of stroke volume (esophageal Doppler) to detect the response to a fluid challenge.
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 major abdominal surgical procedures performed by laparotomy
- •patients undergoing major urological surgical procedures performed by laparotomy
- •patients undergoing major gynecological surgical procedures performed by laparotomy
- •age ≥ 18 years
- •signed informed consent
排除标准
- •pregnant women
- •esophageal disease
- •aortic valve disease
- •allergy to gelatin
- •BMI > 35
- •beta blocker treatment, antiarrhythmic treatment, arrhythmia, pace-maker,
- •presence of an arterio-venous shunt or of any other vascular disease on upper limb
研究组 & 干预措施
Surgical patients
Experimental
- Nexfin (Pulse Pressure Variation)
- Radical 7 (Pleth Variability Index)
- CardioQ (stroke volume)
干预措施: - Nexfin (Pulse Pressure Variation) - Radical 7 (Pleth Variability Index) - CardioQ (stroke volume) (Device)
结局指标
主要结局
Ability of Pleth Variability Index and of Pulse Pressure Variation to detect the response to a fluid challenge
时间窗: during the intraoperative period
Three fluid challenges, 250 mL of a gelatine solution, are planned. Pleth Variability Index and Pulse Pressure Variation are compared to the measurement of stroke volume by Esophageal Doppler (the reference method)
次要结局
- Inability to obtain Pleth Variability Index or Pulse Pressure Variation indices(during the intraoperative period)
研究者
研究点 (2)
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