Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-19

Study Completion Date

2018-07-19

Brief Summary

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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

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Detailed Description

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Conditions

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Failing Fontan Physiology Pediatric Congenital Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Hayek RTX ventilator

Participants will receive noninvasive negative pressure ventilation.

Group Type EXPERIMENTAL

Hayek RTX ventilator

Intervention Type DEVICE

Participants will receive Noninvasive negative pressure from the Hayek RTX ventilator for 30 minutes during diagnostic catheterization procedure.

Interventions

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Hayek RTX ventilator

Participants will receive Noninvasive negative pressure from the Hayek RTX ventilator for 30 minutes during diagnostic catheterization procedure.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No