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Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

NCT03223168 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-10-07

No results posted yet for this study

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

Interventions

DEVICE

Hayek RTX ventilator

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

Sponsors & Collaborators

Principal Investigators

  • David Peng, MD · University of Michigan

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-19
Primary Completion
2018-06-13
Completion
2018-07-19
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03223168 on ClinicalTrials.gov