Trials / Completed
CompletedNCT05383651
Post Market, Prospective Multicenter Observational Study of the Safety and Performance of Bellavista Ventilator
International Prospective Multicenter Observational Study of the Safety and Performance of Bellavista Ventilator and the IFLow Sensor During Routine Use in the Neonatal, Pediatric, and Adult Intensive Care Unit
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 350 (actual)
- Sponsor
- Vyaire Medical · Industry
- Sex
- All
- Age
- 6 Months
- Healthy volunteers
- Not accepted
Summary
This prospective post market clinical follow up (PMCF) study will evaluate the safety and performance of bellavista ventilator and the iFlow sensors in daily clinical routine.
Detailed description
A prospective, multicenter, single-cohort post market observational study, which will analyze data from neonatal, pediatric and adult patients, who are ventilated with the bellavista ventilator. Ventilator data are continuously recorded in the bellavista ventilator. Patient related data will be recorded in an electronic case report form (CRF). Data from the ventilator and the eCRF are then combined and the primary and secondary endpoints calculated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | bellavista 1000 | observational use of Bellavista 1000 ventilator in adult ventilated patients |
| DEVICE | bellavista 1000 neo | observational use of Bellavista 1000 ventilator in neonatal ventilated patients |
Timeline
- Start date
- 2023-02-01
- Primary completion
- 2024-05-31
- Completion
- 2024-06-30
- First posted
- 2022-05-20
- Last updated
- 2024-09-05
Locations
2 sites across 2 countries: Canada, Switzerland
Source: ClinicalTrials.gov record NCT05383651. Inclusion in this directory is not an endorsement.