NCT03706430终止不适用
Validation of RPVi as a Parameter to Predict Fluid Responsiveness
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Comparison of RPVi to SVV and/or PPV
研究概览
简要总结
This is a prospective, nonrandomized, sequential data collection study to evaluate the ability of RPVi to predict fluid responsiveness in comparison with other dynamic parameters including stroke volume variation (SVV) and/or pulse pressure variation (PPV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •18 years of age or older at the time of consent
- •Scheduled for elective surgery requiring general anesthesia and mechanical ventilation
- •Arterial line and other standard of care line placement indicated as part of the scheduled surgical procedure
排除标准
- •Patients diagnosed with or history of heart failure, angina, pulmonary heart disease, rheumatic heart disease, cardiomyopathy, congenital heart disease, or valvular heart disease.
- •Patients scheduled for or has had a liver transplant
- •Patients with surgeries at or around site of sensor placement or skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of pulse-oximeter physiological parameters during the study.
- •Patients with cardiac arrhythmias
- •Patients with intracardiac shunts
研究组 & 干预措施
Pulse Co-Oximeter sensor
Experimental
All subjects are enrolled into this arm and will receive an investigational pulse CO-Oximeter sensors.
干预措施: Pulse CO-Oximeter sensor (Device)
结局指标
主要结局
Comparison of RPVi to SVV and/or PPV
时间窗: approximately 2-6 hours during surgery
To evaluate the ability of RPVi to predict fluid responsiveness in comparison with other dynamic parameters including Stroke Volume Variation (SVV) and/or Pulse Pressure Variation (PPV) using Bland Altman analysis.
次要结局
未报告次要终点
研究者
研究点 (1)
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