Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

Not Applicable

Completed

• Conditions: Pediatric Congenital Heart Disease; Failing Fontan Physiology
• Interventions: Device: Hayek RTX ventilator

• Registration Number: NCT03223168
• Lead Sponsor: University of Michigan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-17
• Study Start: 2017-07-19
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Primary Completion: 2018-06-13
• Study Completion: 2018-07-19
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-04
• Last Update Posted: 2019-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hayek RTX ventilator	Hayek RTX ventilator	Participants will receive noninvasive negative pressure ventilation.

Primary Outcome Measures

Name	Time	Method
Hemodynamics as characterized by change in cardiac output	Baseline, 45 Minutes	Cardiac output will be measured in liters per minute at baseline and completion of noninvasive negative pressure ventilation
Hemodynamics as characterized by change in pulmonary blood flow	Baseline, 45 Minutes	Change in pulmonary blood flow will be measured at baseline and completion of noninvasive negative pressure ventilation.
Hemodynamics as characterized by change in pulmonary artery pressure	Baseline, 45 Minutes	Pulmonary artery wedge pressure will be measured in millimeters of mercury (mmHg) at baseline and completion of noninvasive negative pressure ventilation.
Hemodynamics as characterized by change in systemic arterial saturation	Baseline, 45 Minutes	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.

Trial Locations

Locations (1)

University of MIchigan; 🇺🇸 Ann Arbor, Michigan, United States