search
Back to results

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
Tarek Alsaied
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Single-ventricle

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 21, 2022
Last Updated
October 2, 2023
Sponsor
Tarek Alsaied
search

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

We'll reach out to this number within 24 hrs