Post Market, Prospective Multicenter Observational Study of the Safety and Performance of Bellavista Ventilator
NCT ID: NCT05383651
Last Updated: 2024-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
350 participants
OBSERVATIONAL
2023-02-01
2024-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adults
bellavista 1000
observational use of Bellavista 1000 ventilator in adult ventilated patients
Pediatric/ Neonates
bellavista 1000 neo
observational use of Bellavista 1000 ventilator in neonatal ventilated patients
Interventions
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bellavista 1000
observational use of Bellavista 1000 ventilator in adult ventilated patients
bellavista 1000 neo
observational use of Bellavista 1000 ventilator in neonatal ventilated patients
Eligibility Criteria
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Inclusion Criteria
* Patient in ICU setting
* Signed informed consent per ethical committee requirements
Exclusion Criteria
* The clinical care team does not agree with inclusion of the patient to the study
6 Months
ALL
No
Sponsors
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Vyaire Medical
INDUSTRY
Responsible Party
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Locations
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University Health Network
Toronto, Ontario, Canada
University Children's Hospital Zürich
Zurich, Canton of Zurich, Switzerland
Countries
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Other Identifiers
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100-P0243
Identifier Type: -
Identifier Source: org_study_id
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