Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

University of Michigan10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Failing Fontan Physiology Pediatric Congenital Heart Disease

Interventions

Hayek RTX ventilatorDEVICE

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

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

University of MIchigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Hemodynamics as characterized by change in pulmonary artery pressure

Pulmonary artery wedge pressure will be measured in millimeters of mercury (mmHg) at baseline and completion of noninvasive negative pressure ventilation.

Time frame: Baseline, 45 Minutes

Hemodynamics as characterized by change in pulmonary blood flow

Change in pulmonary blood flow will be measured at baseline and completion of noninvasive negative pressure ventilation.

Time frame: Baseline, 45 Minutes

Hemodynamics as characterized by change in systemic arterial saturation

Systemic arterial saturation measures the amount of oxygen in the blood stream. Systemic arterial saturation will be registered at baseline and completion of noninvasive negative pressure ventilation.

Time frame: Baseline, 45 Minutes

Hemodynamics as characterized by change in cardiac output

Cardiac output will be measured in liters per minute at baseline and completion of noninvasive negative pressure ventilation

Time frame: Baseline, 45 Minutes

Data from ClinicalTrials.gov

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