Cardiac Output Measurement in Pediatric Intensive Care Unit by Metabolic Monitor (Fick Method) : Prospective Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Intra-class correlation (or concordance) between the measurement of cardiac output (in ml/min) by Fick's method and by echocardiography
研究概览
简要总结
Cardiac output measurement is one of the most frequently used haemodynamic parameter used for intensive care unit (ICU) patients. In pediatric ICU, it is often measured with echocardiography that is a non-invasive method but is operator dependant and can't provide continuous monitoring.
The goal of this clinical trial is to evaluate the feasibility of cardiac output measurement by Fick's method, non-invasive and allowing continuous monitoring, in comparison to echocardiography in pediatric intensive care unit.
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
- 28 Days 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient under 18 years old
- •Patient over 10 kg
- •Patient requiring intubation or intubated with a cuffed tube
- •Patient requiring a central venous line in superior vena cava territory
排除标准
- •Mechanical ventilation with leak
- •Bad echogenicity preventing echocardiography
- •Absence of written informed consent
- •Patient not affiliated to French Health Insurance or not covered by public health insurance
- •Patient with a legal protection
研究组 & 干预措施
Pediatric Intensive Care Units Patients
Patients under 18 admitted in pediatric intensive care unit
干预措施: Fick's method (Diagnostic Test)
Pediatric Intensive Care Units Patients
Patients under 18 admitted in pediatric intensive care unit
干预措施: Echocardiography (Diagnostic Test)
结局指标
主要结局
Intra-class correlation (or concordance) between the measurement of cardiac output (in ml/min) by Fick's method and by echocardiography
时间窗: Up to day 3
次要结局
- Adverse events on the day of catheter removal(Up to 21 days)
- Variations of cardiac output before and after Leg Raise Test(Up to day 3)
- Adverse events on the day of catheterization(Up to 21 days)