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Negative Pressure Ventilation

Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

N/A
Waitlist Available
Led By David Peng, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 45 minutes
Awards & highlights
No Placebo-Only Group

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

Eligible Conditions
  • Congenital Heart Defects
  • Fontan Physiology

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 45 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 45 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hemodynamics as characterized by change in cardiac output
Hemodynamics as characterized by change in pulmonary artery pressure
Hemodynamics as characterized by change in pulmonary blood flow
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hayek RTX ventilatorExperimental Treatment1 Intervention
Participants will receive noninvasive negative pressure ventilation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hayek RTX ventilator
2017
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,861 Previous Clinical Trials
6,441,014 Total Patients Enrolled
2 Trials studying Fontan Physiology
83 Patients Enrolled for Fontan Physiology
David Peng, MDPrincipal InvestigatorUniversity of Michigan
~1 spots leftby Dec 2025
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