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

Tarek Alsaied

Status: Completed

Conditions: Single-ventricle

Treatments: Device: Hands-free oral-positive pressure device (oPEP)

Study type: Interventional

Funder types: Other

Identifiers

NCT05634226

STUDY22050151

Details and patient eligibility

About

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.

Full description

The aortic VTI secondary outcome was inadvertently left out of the initial registration and is now reported

Enrollment: 15 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with single ventricle with Fontan palliation
• Over the age of 8 years who would be cooperative with breathing through the oPEP device

Exclusion criteria

• Patients with Fontan palliation under the age of 8 years
• Patients who have interrupted inferior vena cava
• Patients with abnormal pulmonary artery anatomy

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Hands-free oral-positive pressure device (oPEP)

Experimental group

Treatment:

Device: Hands-free oral-positive pressure device (oPEP)