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.
Study Type
OBSERVATIONAL
Enrollment
350
observational use of Bellavista 1000 ventilator in adult ventilated patients
observational use of Bellavista 1000 ventilator in neonatal ventilated patients
University Health Network
Toronto, Ontario, Canada
University Children's Hospital Zürich
Zurich, Canton of Zurich, Switzerland
Ventilator Performance - Relationship between the set and observed Positive End-Expiratory Pressure (PEEP)
Difference between set and observed PEEP
Time frame: through study completion, an average of 12 hours- 24 days
Ventilator Performance - Relationship between the set and observed Peak Inspiratory Pressure (PIP)
Difference between set and observed PIP
Time frame: through study completion, an average of 12 hours- 24 days
Ventilator Performance - Relationship between the set and observed Continuous Positive Airway Pressure (CPAP)
Difference between set and observed CPAP
Time frame: through study completion, an average of 12 hours- 24 days
Ventilator Performance - Relationship between the set and observed tidal volume
Difference between set and observed tidal volume
Time frame: through study completion, an average of 12 hours- 24 days
Ventilator Performance - Relationship between the set and observed flow rate
Difference between set and observed flow rate
Time frame: through study completion, an average of 12 hours- 24 days
Ventilator Safety - Device failure rate
malfunction of the ventilators necessitating removal of a patient to another ventilation mode or ventilator (bellavista technical alarms with ID higher than 300)
Time frame: through study completion, an average of 12 hours- 24 days
Ventilator Safety - Descriptive statistical analysis of all ventilator alarm events
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A summary table presenting number, type and duration of ventilator alarms within study population
Time frame: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Duration of mechanical ventilation
Number of days under invasive mechanical ventilation
Time frame: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Reintubation rate
Number of patients with the need of reintubation, considered by the physician in charge of the patients, after a scheduled or unplanned extubation
Time frame: through study completion, an average of 12 hours- 24 days
Length of ICU stay
Period of time that the bellavista-ventilated patients spend in the ICU before being discharged (alive or died)
Time frame: through study completion, an average of 12 hours- 24 days
Length of hospital stay
Period of time that the bellavista-ventilated patients spend in the hospital after ICU discharge
Time frame: through study completion, an average of 12 hours- 24 days
Ventilator Safety - Number of study participants with device related adverse events
Number of malfunction of the investigational device leading to potential or actual patient harm
Time frame: through study completion, an average of 12 hours- 24 days
Extubation failure
Defined as the need of reintubation within the first 48 hours from a scheduled extubation
Time frame: through study completion, an average of 12 hours- 24 days
Hospital mortality
Number of bellavista-ventilated patients who died during the hospital admission after the ICU discharge
Time frame: through study completion, an average of 12 hours- 24 days
Failure of noninvasive treatment
Need of orotracheal intubation in bellavista-ventilated patients after an attempt of noninvasive treatment (NIV and HFOT) that failed, defined by the physician in charge of the patient.
Time frame: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Pneumothorax rate
Number of confirmed pneumothoraxes during ventilation
Time frame: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Sepsis
Number of patients with sepsis
Time frame: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Bronchopulmonary dysplasia
Need of oxygen or positive airway pressure at 36 weeks corrected age
Time frame: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Retinopathy of prematurity
Number of patients with retinopathy of prematurity and level
Time frame: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Necrotizing enterocolitis
Number of patients with necrotizing enterocolitis
Time frame: through study completion, an average of 12 hours- 24 days
Intraventricular hemorrhage
Number of patients with intraventricular hemorrhage
Time frame: through study completion, an average of 12 hours- 24 days