Pilot Study of a Non-Invasive Central Venous Pressure Monitoring System in Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Accuracy of Mespere VENUS 2000CVP
研究概览
简要总结
The goal of this research study is to determine the feasibility and accuracy of Mespere Life Science non-invasive central venous pressure monitoring system (Mespere VENUS 2000CVP system) in children with congenital heart disease (CHD).
详细描述
Central venous pressure (CVP), also known as right atrial pressure (RAp), is a reflection of the right heart filling pressure i.e the preload of the right ventricle. Assessment of the CVP is essential in the management of different clinical situations in children. Invasive CVP monitoring by placement of a CVP catheter either in the internal jugular vein or the subclavian vein is the gold standard way of measuring the CVP both in children and adults. However, placing a CVP catheter in a child can be challenging, time consuming, often requires the child to be sedated and it is not without complications.
Being able to reliably measure the CVP noninvasively would be of great benefit for sick children as it may allow diagnoses to be made quickly and help guide treatment.
The goal of this proposal is to determine the feasibility and accuracy of Mespere Life Science non-invasive central venous pressure monitoring system (Mespere VENUS 2000CVP system) in children with congenital heart disease (CHD).
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
- 12 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 months of age to 10.9 years of age
- •Scheduled to undergo a cardiac surgery with central venous pressure catheter monitoring at Boston Children's Hospital
排除标准
- •undergo a procedure that does not require a central venous pressure catheter as part of routine monitoring
- •Have a known venous occlusion or any other reason the central venous pressure may be unreliable
- •Allergy to medical grade adhesives or have any pre-existing skin irritation/eczema at the sensor site
- •Emergently scheduled procedures
结局指标
主要结局
Accuracy of Mespere VENUS 2000CVP
时间窗: The data will be collected for the length of the cardiac surgery, up to 6 hours.
The correlation between the non-invasive measurements from the Mespere VENUS 2000CVP system and the invasive central venous pressure measurements that are continuously collected as standard of care.
次要结局
未报告次要终点
研究者
Kirsten Odegard
Cardiac Anesthesiologist
Boston Children's Hospital