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Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

University of Michigan logo

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)

10 participants in 1 patient group

Hayek RTX ventilator
Experimental group
Description:
Participants will receive noninvasive negative pressure ventilation.
Treatment:
Device: Hayek RTX ventilator

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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