NCT02485457终止不适用
Validation of NICOM for the Detection of Modification of Stroke Volume
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Stroke volume variation
研究概览
简要总结
The purpose of this study is to evaluate the ability of NICOM (Noninvasive cardiac output monitor) to detect stroke volume variation induced by leg raising or fluid expansion during surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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 general anesthesia with an expected duration exceeding two hours
- •gastrointestinal surgery, urological or gynecological surgery.
排除标准
- •Difficulty of venous access.
- •Contraindication for the use of oesophageal Doppler
- •Contraindication for the use of Nicom
- •Contraindication for the use of bispectral index
- •Pregnant or lactating women
研究组 & 干预措施
Low volume
Experimental
The protocol will follow the following steps :
- basal measurements (heart rate, arterial pressure, stroke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
- followed by passive leg rising and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
- second basal measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
- followed by low volume loading (250 ml of Ringer solution) and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
干预措施: Volume loading (Procedure)
Low volume
Experimental
The protocol will follow the following steps :
- basal measurements (heart rate, arterial pressure, stroke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
- followed by passive leg rising and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
- second basal measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
- followed by low volume loading (250 ml of Ringer solution) and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
干预措施: Ringer solution (Drug)
High volume
Experimental
The protocol will follow the following steps :
- basal measurements (heart rate, arterial pressure, stroke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
- followed by passive leg rising and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
- second basal measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
- followed by low volume loading (500 ml of Ringer solution) and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
干预措施: Volume loading (Procedure)
High volume
Experimental
The protocol will follow the following steps :
- basal measurements (heart rate, arterial pressure, stroke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
- followed by passive leg rising and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
- second basal measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
- followed by low volume loading (500 ml of Ringer solution) and additional measurements (heart rate, arterial pressure, stoke volume estimated by esophageal Doppler, stoke volume estimated by Nicom)
干预措施: Ringer solution (Drug)
结局指标
主要结局
Stroke volume variation
时间窗: 6 hours
Stroke volumes measured by esophageal Doppler and by Nicom: at baseline, after leg passive rising, and after volume loading
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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