Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

January 31, 2024

Study Completion Date

January 31, 2024

Conditions
Single-ventricle
Interventions
DEVICE

Hands-free oral-positive pressure device (oPEP)

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. We 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, we will have patients use the device after their clinical echocardiogram for their clinic appointment. We 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.

Trial Locations (1)

15235

UPMC Children's Hospital Pittsburgh, Pittsburgh

All Listed Sponsors
lead

Tarek Alsaied

OTHER

NCT05634226 - Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan | Biotech Hunter | Biotech Hunter