Cardiac Output Analysis by Cardiographic Impedance: a Validation Study of the Niccomo Non-invasive Monitor in Post-operative Cardiac Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- agreement between cardiac outputs measured by Pulmonary Arterial Catheter (PAC) and Niccomo
研究概览
简要总结
Cardiac surgery is at high risk of low cardiac output syndrome after procedure. Monitoring cardiac function, and especially cardiac output, is important to identify cardiovascular dysfunction and to introduce and adjust optimal therapies. Invasive monitor such as pulmonary arterial catheter or transpulmonary thermodilution provide precise measurements but need an invasive access to arterial and central venous route, with possible complications.
Cardiographic bioimpedencemetry (Niccomo device, Imedex Corp) allows a non invasive measurement of cardiac output and some other parameters of cardiovascular function. Nevertheless, the reliability of this device has been little studied after cardiac surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •age > 18 y/o
- •Patients benefiting from cardiac surgery AND pulmonary arterial catheter monitoring
排除标准
- •Aortic regurgitation grade 3-4
- •Uncontrolled Hypertension (MAP > 130 mmHg)
- •Circulatory or cardiac assistance
- •Active pacemaker
结局指标
主要结局
agreement between cardiac outputs measured by Pulmonary Arterial Catheter (PAC) and Niccomo
时间窗: 48 hours
Cardiac outputs and systolic ejection volumes are measured at 10 different time-points and agreement between the 2 devices are explored
次要结局
- Left Ventricular Ratio(48 hours)
- Pre-ejection Period(48 hours)
- Systolic Time Ratio(48 hours)
- Velocity Index(48 hours)