NCT03172689已完成不适用
Validation of an Ultrasound Oesophageal Doppler Cardiac Output Monitor (ODM+, CardioQ) Versus a Transpulmonary Thermodilution Cardiac Output Monitor (TPTD, PiCCO)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- cardiac output
研究概览
简要总结
To compare the less invasive Oesophageal Doppler cardiac output Monitor (ODM) to the invasive (standard of care) Transpulmonary Thermodilution cardiac output monitor (TPTD) in children.
详细描述
This is a validation study. The study period starts as soon as CMO approval is acquired and will end after inclusion of 17 patients. This study is designed to test the effectiveness of a non invasive ODM catheter compared to the invasive, gold standard, TPTD technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 0 to 16 years with an indication for invasive CO monitoring (TPTD). Indication for invasive CO monitoring always implies intubation and sedation.
- •Signed informed consent
排除标准
- •Congenital or acquired cardiovascular diseases (intracardiac/extracardiac intrathoracic shunt
- •Cardiac valve diseases
- •Aortic arch anomalies
- •Tissue necrosis of oesophagus
- •Carcinoma of pharynx, larynx of oesophagus
- •Severe bleeding diatheses
- •Age > 16 years
- •Weight < 3.5 kg or > 50 kg.
研究组 & 干预措施
CardioQ
Other
CardioQ will be used as CO monitor simultaneously with the standard of care PiCCO CO monitor
干预措施: CardioQ (Device)
结局指标
主要结局
cardiac output
时间窗: 24 hours
liter/m2/minute
stroke volume
时间窗: 24 hours
milliliters
次要结局
- stroke distance(24 hours)
- flow time corrected(24 hours)
研究者
研究点 (2)
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