Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan
Completed · Not applicable
Conditions studied: Single-ventricle
In brief
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.
Key facts
- Study ID
- NCT05634226
- Run by
- Tarek Alsaied
- People needed
- 15
- Starts
- 2023-08-01
- Expected to finish
- 2024-01-31
- Last updated by the study team
- 2025-02-10
Who can join
Age: 8 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with single ventricle with Fontan palliation
- Over the age of 8 years who would be cooperative with breathing through the oPEP device
You may not qualify if…
- Patients with Fontan palliation under the age of 8 years
- Patients who have interrupted inferior vena cava
- Patients with abnormal pulmonary artery anatomy
Where it is running
- UPMC Children's Hospital Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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