Status:
COMPLETED
Post Market, Prospective Multicenter Observational Study of the Safety and Performance of Bellavista Ventilator
Lead Sponsor:
Vyaire Medical
Conditions:
Ventilation Therapy; Complications
Eligibility:
All Genders
6+ years
Brief 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. Vent...
Eligibility Criteria
Inclusion
- Patient ventilated with bellavista
- Patient in ICU setting
- Signed informed consent per ethical committee requirements
Exclusion
- Patients expected to be ventilated less than 12 hours
- The clinical care team does not agree with inclusion of the patient to the study
Key Trial Info
Start Date :
February 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT05383651
Start Date
February 1 2023
End Date
June 30 2024
Last Update
September 5 2024
Active Locations (2)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2N2
2
University Children's Hospital Zürich
Zurich, Canton of Zurich, Switzerland, 8032