Clinical trial NCT05383651: Post Market, Prospective Multicenter Observational Study of the Safety and Performance of Bellavista Ventilator
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilation Therapy; Complications
Lead sponsor: Vyaire Medical
Sponsor class: INDUSTRY
First posted: 2022-05-20
Enrollment: 350
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates and adults ventilated with Bellavista ventilator in intensive care units.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ventilator Performance - Relationship between the set and observed Positive End-Expiratory Pressure (PEEP)
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Ventilator Performance - Relationship between the set and observed Peak Inspiratory Pressure (PIP)
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Ventilator Performance - Relationship between the set and observed Continuous Positive Airway Pressure (CPAP)
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Ventilator Performance - Relationship between the set and observed tidal volume
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Ventilator Performance - Relationship between the set and observed flow rate
timeFrame: through study completion, an average of 12 hours- 24 days
Secondary outcomes:
measure: Ventilator Safety - Device failure rate
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Ventilator Safety - Descriptive statistical analysis of all ventilator alarm events
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Analysis of patient-ventilator interactions - Duration of mechanical ventilation
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Analysis of patient-ventilator interactions - Reintubation rate
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Length of ICU stay
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Length of hospital stay
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Ventilator Safety - Number of study participants with device related adverse events
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Extubation failure
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Hospital mortality
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Failure of noninvasive treatment
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Analysis of patient-ventilator interactions - Pneumothorax rate
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Analysis of patient-ventilator interactions - Sepsis
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Analysis of patient-ventilator interactions - Bronchopulmonary dysplasia
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Analysis of patient-ventilator interactions - Retinopathy of prematurity
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Analysis of patient-ventilator interactions - Necrotizing enterocolitis
timeFrame: through study completion, an average of 12 hours- 24 days
measure: Intraventricular hemorrhage
timeFrame: through study completion, an average of 12 hours- 24 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Zürich
country: Switzerland
facility: University Children's Hospital Zürich
state: Zurich
Study officials:
References: