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

Single-ventricle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05634226
• Other study ID #: STUDY22050151
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: October 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Single-ventricle
• Univentricular Heart

Intervention

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.

Locations

Country	Name	City	State
United States	UPMC Children's Hospital Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Tarek Alsaied

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pulmonary pulsatility index	This will be measured by echocardiogram	The change is between enrollment echocardiogram and echocardiogram after 4 week use of the device