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

Ventilation Therapy; Complications Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Ventilation Therapy; Complications
Clinical Trial Details
NCT number NCT05383651
Study type Observational
Source Vyaire Medical
Contact
Status Not yet recruiting
Phase
Start date November 2022
Completion date March 2024
View Details
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