Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan
Primary Purpose
Single-ventricle
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hands-free oral-positive pressure device (oPEP)
Sponsored by
About this trial
This is an interventional prevention trial for Single-ventricle
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
Sites / Locations
- UPMC Children's Hospital Pittsburgh
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hands-free oral-positive pressure device (oPEP)
Arm Description
Outcomes
Primary Outcome Measures
Change in Pulmonary pulsatility index
This will be measured by echocardiogram
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05634226
Brief Title
Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan
Official Title
Oral Positive Pressure Device (oPEP) Effect on Flow Pulsatility in the Fontan Circuit
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tarek Alsaied
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Single-ventricle
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hands-free oral-positive pressure device (oPEP)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Hands-free oral-positive pressure device (oPEP)
Intervention Description
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 Outcome Measure Information:
Title
Change in Pulmonary pulsatility index
Description
This will be measured by echocardiogram
Time Frame
The change is between enrollment echocardiogram and echocardiogram after 4 week use of the device
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
UPMC Children's Hospital Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15235
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Simple Non-invasive Breathing Device to Improve Pulmonary Flow Pusatility in Single Ventricle Post Fontan
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