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Completed

NCT Number: NCT05634226

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

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.

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Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Children's Hospital Pittsburgh

Pittsburgh, Pennsylvania, 15235, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Pulmonary Pulsatility Index

    Time frame: 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 outcomes

  1. Aortic Valve VTI

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tarek Alsaied

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2022
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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