Trials / Completed
CompletedNCT03223168
Noninvasive Negative Pressure Ventilation to Support Failing Fontan Physiology
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- All
- Age
- 10 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hayek RTX ventilator | Participants will receive Noninvasive negative pressure from the Hayek RTX ventilator for 30 minutes during diagnostic catheterization procedure. |
Timeline
- Start date
- 2017-07-19
- Primary completion
- 2018-06-13
- Completion
- 2018-07-19
- First posted
- 2017-07-21
- Last updated
- 2019-10-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03223168. Inclusion in this directory is not an endorsement.