Post Market, Prospective Multicenter Observational Study of the Safety and Performance of Bellavista Ventilator

Vyaire Medical

Status: Completed

Conditions: Ventilation Therapy; Complications

Treatments: Device: bellavista 1000; Device: bellavista 1000 neo

Study type: Observational

Funder types: Industry

Identifiers

NCT05383651

100-P0243

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient ventilated with bellavista
• Patient in ICU setting
• Signed informed consent per ethical committee requirements

Exclusion criteria

• Patients expected to be ventilated less than 12 hours
• The clinical care team does not agree with inclusion of the patient to the study

Trial design

350 participants in 2 patient groups

Adults

Treatment:

Device: bellavista 1000

Pediatric/ Neonates

Treatment:

Device: bellavista 1000 neo