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Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

Primary Purpose

Failing Fontan Physiology, Pediatric Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hayek RTX ventilator
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Failing Fontan Physiology

Eligibility Criteria

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

Inclusion Criteria:

1. Patients with Fontan physiology with clinical evidence of Fontan failure as defined by those with one of the following in addition to Fontan circulation: New York Heart Association Class II, fluid retention, cyanosis, protein losing enteropathy, renal/hepatic dysfunction and/or subjectively qualify for hemodynamic assessment (by primary cardiologist).

Exclusion Criteria:

  1. Patients which will likely require intubation for catheterization
  2. Severely depressed systemic ventricular systolic function
  3. Baseline airway obstruction
  4. Plastic bronchitis
  5. Significant OUTFLOW obstruction

Sites / Locations

  • University of MIchigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hayek RTX ventilator

Arm Description

Participants will receive noninvasive negative pressure ventilation.

Outcomes

Primary Outcome Measures

Hemodynamics as characterized by change in pulmonary artery pressure
Pulmonary artery wedge pressure will be measured in millimeters of mercury (mmHg) at baseline and completion of noninvasive negative pressure ventilation.
Hemodynamics as characterized by change in pulmonary blood flow
Change in pulmonary blood flow will be measured at baseline and completion of noninvasive negative pressure ventilation.
Hemodynamics as characterized by change in systemic arterial saturation
Systemic arterial saturation measures the amount of oxygen in the blood stream. Systemic arterial saturation will be registered at baseline and completion of noninvasive negative pressure ventilation.
Hemodynamics as characterized by change in cardiac output
Cardiac output will be measured in liters per minute at baseline and completion of noninvasive negative pressure ventilation

Secondary Outcome Measures

Full Information

First Posted
July 17, 2017
Last Updated
October 4, 2019
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03223168
Brief Title
Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology
Official Title
Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 19, 2017 (Actual)
Primary Completion Date
June 13, 2018 (Actual)
Study Completion Date
July 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess for acute hemodynamic changes after implementation of noninvasive negative pressure ventilation (as compared with spontaneous respiration) in pediatric patients with Fontan failure using modern negative pressure ventilators

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failing Fontan Physiology, Pediatric Congenital Heart Disease

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hayek RTX ventilator
Arm Type
Experimental
Arm Description
Participants will receive noninvasive negative pressure ventilation.
Intervention Type
Device
Intervention Name(s)
Hayek RTX ventilator
Intervention Description
Participants will receive Noninvasive negative pressure from the Hayek RTX ventilator for 30 minutes during diagnostic catheterization procedure.
Primary Outcome Measure Information:
Title
Hemodynamics as characterized by change in pulmonary artery pressure
Description
Pulmonary artery wedge pressure will be measured in millimeters of mercury (mmHg) at baseline and completion of noninvasive negative pressure ventilation.
Time Frame
Baseline, 45 Minutes
Title
Hemodynamics as characterized by change in pulmonary blood flow
Description
Change in pulmonary blood flow will be measured at baseline and completion of noninvasive negative pressure ventilation.
Time Frame
Baseline, 45 Minutes
Title
Hemodynamics as characterized by change in systemic arterial saturation
Description
Systemic arterial saturation measures the amount of oxygen in the blood stream. Systemic arterial saturation will be registered at baseline and completion of noninvasive negative pressure ventilation.
Time Frame
Baseline, 45 Minutes
Title
Hemodynamics as characterized by change in cardiac output
Description
Cardiac output will be measured in liters per minute at baseline and completion of noninvasive negative pressure ventilation
Time Frame
Baseline, 45 Minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Patients with Fontan physiology with clinical evidence of Fontan failure as defined by those with one of the following in addition to Fontan circulation: New York Heart Association Class II, fluid retention, cyanosis, protein losing enteropathy, renal/hepatic dysfunction and/or subjectively qualify for hemodynamic assessment (by primary cardiologist). Exclusion Criteria: Patients which will likely require intubation for catheterization Severely depressed systemic ventricular systolic function Baseline airway obstruction Plastic bronchitis Significant OUTFLOW obstruction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Peng, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of MIchigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

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