Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

Pediatric Congenital Heart Disease Clinical Trial

Official title:

Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03223168
• Other study ID #: HUM00131186
• Status: Completed
• Phase: N/A
• Start date: July 19, 2017
• Est. completion date: July 19, 2018

Study information

• Verified date: October 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 19, 2018
• Est. primary completion date: June 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Failing Fontan Physiology
• Heart Diseases
• Pediatric Congenital Heart Disease

Intervention

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

Locations

Country	Name	City	State
United States	University of MIchigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 45 Minutes
Primary	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.	Baseline, 45 Minutes
Primary	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.	Baseline, 45 Minutes
Primary	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	Baseline, 45 Minutes