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临床试验/NCT05634226
NCT05634226已完成不适用

Oral Positive Pressure Device (oPEP) Effect on Flow Pulsatility in the Fontan Circuit

Tarek Alsaied2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年8月1日最近更新:
适应症

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

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

发起方
Tarek Alsaied
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tarek Alsaied

Assistant Professor

University of Pittsburgh

研究点 (2)

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