Trial Outcomes & Findings for Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan (NCT NCT05634226)

Last Updated: 2025-02-10

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

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

Results posted on

2025-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	Hands-free Oral-positive Pressure Device (oPEP) 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.
Overall Study STARTED	15
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hands-free Oral-positive Pressure Device (oPEP) n=15 Participants 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.
Age, Continuous	19.9 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Hands-free Oral-positive Pressure Device (oPEP) n=11 Participants 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.
Change in Pulmonary Pulsatility Index Baseline	51.6 Ratio Standard Deviation 16.6
Change in Pulmonary Pulsatility Index Post treatment	57.6 Ratio Standard Deviation 21.1

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Hands-free Oral-positive Pressure Device (oPEP) n=15 Participants 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.
Aortic Valve VTI Baseline	19.8 cm/sec Standard Deviation 4.9
Aortic Valve VTI Post device use	17.4 cm/sec Standard Deviation 1.8

Adverse Events

Hands-free Oral-positive Pressure Device (oPEP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tarek Alsaied

Children's Hospital of Pittsburgh

Phone: 5136521226

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place