Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

Completed · Not applicable

Conditions studied: Failing Fontan Physiology, Pediatric Congenital Heart Disease

In brief

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

Key facts

Study ID

NCT03223168

Run by

University of Michigan

People needed

10

Starts

2017-07-19

Expected to finish

2018-07-19

Last updated by the study team

2019-10-07

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Patients which will likely require intubation for catheterization
• Severely depressed systemic ventricular systolic function
• Baseline airway obstruction
• Plastic bronchitis
• Significant OUTFLOW obstruction

Where it is running

• University of MIchigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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