Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Failing Fontan Physiology
- Sponsor
- University of Michigan
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Hemodynamics as characterized by change in pulmonary blood flow
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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
Investigators
David Peng
Assistant Professor of Pediatrics and Communicable Diseases
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Hemodynamics as characterized by change in pulmonary blood flow
Time Frame: 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 cardiac output
Time Frame: Baseline, 45 Minutes
Cardiac output will be measured in liters per minute at baseline and completion of noninvasive negative pressure ventilation
Hemodynamics as characterized by change in pulmonary artery pressure
Time Frame: 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 systemic arterial saturation
Time Frame: 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.