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

Not Applicable

Completed

• Conditions: Single-ventricle
• Interventions: Device: Hands-free oral-positive pressure device (oPEP)

• Registration Number: NCT05634226
• Lead Sponsor: Tarek Alsaied

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-21
• Study First Posted: 2022-12-02
• Study Start: 2023-08-01
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Results First Submitted: 2024-12-18
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Results First Posted: 2025-02-10
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hands-free oral-positive pressure device (oPEP)	Hands-free oral-positive pressure device (oPEP)	-

Primary Outcome Measures

Name	Time	Method
Change in Pulmonary Pulsatility Index	The change is between enrollment echocardiogram and echocardiogram after 4 week use of the device	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

Secondary Outcome Measures

Name	Time	Method
Aortic Valve VTI	Baseline, 4 weeks	This was measured by echocardiography; Aortic Valve Velocity Time Integral (VTI) Definition: Aortic VTI is a key echocardiographic measurement reflecting stroke distance and cardiac output.; Measurement: Obtained using pulsed-wave Doppler at the left ventricular outflow tract (LVOT) just below the aortic valve.; The VTI is measured by tracing the Doppler envelope of the LVOT flow during systole.; Clinical Importance: Stroke Volume Calculation: Stroke Volume = LVOT VTI × LVOT Area

Trial Locations

Locations (1)

UPMC Children's Hospital Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States