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

NCT05634226 | Completed Results FDA Device

• 1 other identifier: STUDY22050151
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Single-ventricle

Outcome Measures

Primary Outcomes (1)

• Change in Pulmonary Pulsatility Index

  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

  The change is between enrollment echocardiogram and echocardiogram after 4 week use of the device

Secondary Outcomes (1)

• Aortic Valve VTI

  Baseline, 4 weeks

Study Arms (1)

Hands-free oral-positive pressure device (oPEP)

EXPERIMENTAL

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

Interventions

Hands-free oral-positive pressure device (oPEP) DEVICE

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.

Hands-free oral-positive pressure device (oPEP)

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Tarek Alsaied: lead

Study Sites (1)

UPMC Children's Hospital Pittsburgh

Pittsburgh, Pennsylvania, 15235, United States

Location

MeSH Terms

Conditions

Univentricular Heart

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Tarek Alsaied
• Organization: Children's Hospital of Pittsburgh

tarek.alsaied84@gmail.com

5136521226

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 2, 2022
• Study Start: August 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-01

Locations

US (1)