Single-ventricle
Conditions
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
Interventions
DEVICEHands-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.
Sponsors
Tarek Alsaied
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Hands-free Oral-positive Pressure Device (oPEP) |
|---|---|
| Age, Continuous | 19.9 years STANDARD_DEVIATION 8.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
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
Time frame: The change is between enrollment echocardiogram and echocardiogram after 4 week use of the device
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hands-free Oral-positive Pressure Device (oPEP) | Change in Pulmonary Pulsatility Index | Baseline | 51.6 Ratio | Standard Deviation 16.6 |
| Hands-free Oral-positive Pressure Device (oPEP) | Change in Pulmonary Pulsatility Index | Post treatment | 57.6 Ratio | Standard Deviation 21.1 |
p-value: 0.1t-test, 2 sided
Secondary
Aortic Valve VTI
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
Time frame: Baseline, 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hands-free Oral-positive Pressure Device (oPEP) | Aortic Valve VTI | Baseline | 19.8 cm/sec | Standard Deviation 4.9 |
| Hands-free Oral-positive Pressure Device (oPEP) | Aortic Valve VTI | Post device use | 17.4 cm/sec | Standard Deviation 1.8 |
p-value: 0.06t-test, 2 sided