N/A
N=15
Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan
Single-ventricle
Bottom Line
View on ClinicalTrials.gov: NCT05634226 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Change in Pulmonary Pulsatility Index — 51.6; 57.6 Ratio — p=0.1
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hands-free oral-positive pressure device (oPEP) (Device)
- Age
- Pediatric, Adult, Older Adult · 8+ yrs
- Sex
- All
- Sponsor
- Tarek Alsaied
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pulmonary Pulsatility Index |
51.6; 57.6 | 0.1 |
| SECONDARY Aortic Valve VTI |
19.8; 17.4 | 0.06 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05634226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.