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NCT03223168 · ClinicalTrials.gov registry record · NA

Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology

A NA study of Pediatric Congenital Heart Disease and Failing Fontan Physiology, sponsored by University of Michigan.

Completed
Registry status
NA
Development phase
10
Enrollment target
1
Study location

NCT03223168: Completed NA study of Pediatric Congenital Heart Disease and Failing Fontan Physiology, sponsored by University of Michigan.

NCT03223168 is a NA study of Pediatric Congenital Heart Disease and Failing Fontan Physiology that has completed, run by University of Michigan. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03223168, a NA study of Pediatric Congenital Heart Disease and Failing Fontan Physiology, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target
1
Study location

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

Primary Outcome

Pulmonary artery wedge pressure will be measured in millimeters of mercury (mmHg) at baseline and completion of noninvasive negative pressure ventilation.

Interventions

  • DEVICE Hayek RTX ventilator

Study Locations (1)

Michigan

  • University of MIchigan - Ann Arbor

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2017-07-19
Est. Completion 2018-07-19
Phase NA
University of Michigan

1,327 total trials

What the finished NCT03223168 record still lists

NCT03223168 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 2 conditions, with Pediatric Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Hayek RTX ventilator is the first listed.

NCT03223168 reports a single indexed study location in Michigan.

Frequently Asked Questions

What is clinical trial NCT03223168 about?

NCT03223168 is a clinical study titled "Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology". 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

What is the current status of trial NCT03223168?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2017-07-19. Estimated completion is 2018-07-19.

What conditions does trial NCT03223168 study?

This clinical trial studies the following conditions: Pediatric Congenital Heart Disease, Failing Fontan Physiology.

What interventions are being tested in trial NCT03223168?

The interventions under investigation include: Hayek RTX ventilator (DEVICE).

Who is sponsoring clinical trial NCT03223168?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03223168 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pediatric Congenital Heart Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03223168's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03223168, the US trial registry maintained by the National Library of Medicine. NCT03223168 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.