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

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.

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.

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