Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

October 4, 2019 updated by: David Peng, University of Michigan
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hayek RTX ventilator
Participants will receive noninvasive negative pressure ventilation.
Device: Hayek RTX ventilator
Participants will receive Noninvasive negative pressure from the Hayek RTX ventilator for 30 minutes during diagnostic catheterization procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamics as characterized by change in pulmonary artery pressure
Time Frame: Baseline, 45 Minutes
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
Time Frame: Baseline, 45 Minutes
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
Time Frame: 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.
Baseline, 45 Minutes
Hemodynamics as characterized by change in cardiac output
Time Frame: Baseline, 45 Minutes
Cardiac output will be measured in liters per minute at baseline and completion of noninvasive negative pressure ventilation
Baseline, 45 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: David Peng, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2017

Primary Completion (Actual)

June 13, 2018

Study Completion (Actual)

July 19, 2018

Study Registration Dates

First Submitted

July 17, 2017

First Submitted That Met QC Criteria

July 19, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

October 7, 2019

Last Update Submitted That Met QC Criteria

October 4, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00131186

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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