Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

NCT03223168 | Completed FDA Device

• 1 other identifier: HUM00131186
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Failing Fontan Physiology; Pediatric Congenital Heart Disease

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Hayek RTX ventilator

EXPERIMENTAL

Participants will receive noninvasive negative pressure ventilation.

Device: Hayek RTX ventilator

Interventions

Hayek RTX ventilator DEVICE

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

Hayek RTX ventilator

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).

You may not qualify if:

• Patients which will likely require intubation for catheterization
• Severely depressed systemic ventricular systolic function
• Baseline airway obstruction
• Plastic bronchitis
• Significant OUTFLOW obstruction

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of MIchigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• David Peng, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics and Communicable Diseases

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 21, 2017
• Study Start: July 19, 2017
• Primary Completion: June 13, 2018
• Study Completion: July 19, 2018
• Last Updated: October 7, 2019

Record last verified: 2019-10

Locations

US (1)