Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:10 - Any
Updated:8/30/2018
Start Date:July 19, 2017
End Date:July 19, 2018

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Trial Summary
Trial Overview
Inclusion Criteria
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


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
We found this trial at
1
site
University of Michigan
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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mi
from
Ann Arbor, MI
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