Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

University of Michigan

Status: Completed

Conditions: Pediatric Congenital Heart Disease; Failing Fontan Physiology

Treatments: Device: Hayek RTX ventilator

Study type: Interventional

Funder types: Other

Identifiers

NCT03223168

HUM00131186

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 10+ years old

Volunteers: No 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Hayek RTX ventilator

Experimental group

Description:

Participants will receive noninvasive negative pressure ventilation.

Treatment:

Device: Hayek RTX ventilator