Oral Positive Pressure Device (oPEP) Effect on Flow Pulsatility in the Fontan Circuit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Pulmonary Pulsatility Index
研究概览
简要总结
This is a pilot study using a novel, minimal risk, portable, hands-free oral-positive pressure device (oPEP) in patients with Fontan palliation that will examine whether using this device in both the acute and chronic phase will alter Fontan hemodynamics and create pulsatility in the Fontan circuit and thereby increasing cardiac output. This device is easy to use and poses no significant risk to human subjects. The investigators will measure this through echocardiographic measures including pulsatility in different aspects of the Fontan circuit including IVC, hepatic veins, the Fontan conduit, and pulmonary arteries and aortic blood flow measurements. After demonstration of how to use the device appropriately, the investigators will have patients use the device after their clinical echocardiogram for their clinic appointment. The investigators will ask them to use the device at home 3-4 times a day for 10-15 mins and have them return in approximately 4 weeks to have another echocardiogram done with the same measurements.
详细描述
The aortic VTI secondary outcome was inadvertently left out of the initial registration and is now reported
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with single ventricle with Fontan palliation
- •Over the age of 8 years who would be cooperative with breathing through the oPEP device
排除标准
- •Patients with Fontan palliation under the age of 8 years
- •Patients who have interrupted inferior vena cava
- •Patients with abnormal pulmonary artery anatomy
结局指标
主要结局
Change in Pulmonary Pulsatility Index
时间窗: The change is between enrollment echocardiogram and echocardiogram after 4 week use of the device
This will be measured by echocardiogram using Doppler evaluation of the pulmonary artery The Pulmonary Artery Pulsatility Index (PAPI) is calculated using Doppler-derived pulmonary artery velocities: PAPI= (Systolic Velocity - Diastolic Velocity) /Mean Velocity
次要结局
- Aortic Valve VTI(Baseline, 4 weeks)
研究者
Tarek Alsaied
Assistant Professor
University of Pittsburgh
