Failing Fontan Physiology, Pediatric Congenital Heart Disease
Conditions
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
Interventions
DEVICEHayek RTX ventilator
Participants will receive Noninvasive negative pressure from the Hayek RTX ventilator for 30 minutes during diagnostic catheterization procedure.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamics as characterized by change in pulmonary artery pressure | Baseline, 45 Minutes | 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 | Baseline, 45 Minutes | 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 | Baseline, 45 Minutes | 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 | Baseline, 45 Minutes | Cardiac output will be measured in liters per minute at baseline and completion of noninvasive negative pressure ventilation |
Countries
United States
Outcome results
None listed