Post Market, Prospective Multicenter Observational Study of the Safety and Performance of Bellavista Ventilator
- Conditions
- Ventilation Therapy; Complications
- Interventions
- Device: bellavista 1000Device: bellavista 1000 neo
- Registration Number
- NCT05383651
- Lead Sponsor
- Vyaire Medical
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 350
- Patient ventilated with bellavista
- Patient in ICU setting
- Signed informed consent per ethical committee requirements
- Patients expected to be ventilated less than 12 hours
- The clinical care team does not agree with inclusion of the patient to the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adults bellavista 1000 - Pediatric/ Neonates bellavista 1000 neo -
- Primary Outcome Measures
Name Time Method Ventilator Performance - Relationship between the set and observed Continuous Positive Airway Pressure (CPAP) through study completion, an average of 12 hours- 24 days Difference between set and observed CPAP
Ventilator Performance - Relationship between the set and observed Positive End-Expiratory Pressure (PEEP) through study completion, an average of 12 hours- 24 days Difference between set and observed PEEP
Ventilator Performance - Relationship between the set and observed Peak Inspiratory Pressure (PIP) through study completion, an average of 12 hours- 24 days Difference between set and observed PIP
Ventilator Performance - Relationship between the set and observed tidal volume through study completion, an average of 12 hours- 24 days Difference between set and observed tidal volume
Ventilator Performance - Relationship between the set and observed flow rate through study completion, an average of 12 hours- 24 days Difference between set and observed flow rate
- Secondary Outcome Measures
Name Time Method Analysis of patient-ventilator interactions - Reintubation rate through study completion, an average of 12 hours- 24 days Number of patients with the need of reintubation, considered by the physician in charge of the patients, after a scheduled or unplanned extubation
Ventilator Safety - Number of study participants with device related adverse events through study completion, an average of 12 hours- 24 days Number of malfunction of the investigational device leading to potential or actual patient harm
Failure of noninvasive treatment through study completion, an average of 12 hours- 24 days 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.
Analysis of patient-ventilator interactions - Sepsis through study completion, an average of 12 hours- 24 days Number of patients with sepsis
Analysis of patient-ventilator interactions - Bronchopulmonary dysplasia through study completion, an average of 12 hours- 24 days Need of oxygen or positive airway pressure at 36 weeks corrected age
Ventilator Safety - Device failure rate through study completion, an average of 12 hours- 24 days malfunction of the ventilators necessitating removal of a patient to another ventilation mode or ventilator (bellavista technical alarms with ID higher than 300)
Analysis of patient-ventilator interactions - Duration of mechanical ventilation through study completion, an average of 12 hours- 24 days Number of days under invasive mechanical ventilation
Length of ICU stay through study completion, an average of 12 hours- 24 days Period of time that the bellavista-ventilated patients spend in the ICU before being discharged (alive or died)
Length of hospital stay through study completion, an average of 12 hours- 24 days Period of time that the bellavista-ventilated patients spend in the hospital after ICU discharge
Extubation failure through study completion, an average of 12 hours- 24 days Defined as the need of reintubation within the first 48 hours from a scheduled extubation
Analysis of patient-ventilator interactions - Necrotizing enterocolitis through study completion, an average of 12 hours- 24 days Number of patients with necrotizing enterocolitis
Ventilator Safety - Descriptive statistical analysis of all ventilator alarm events through study completion, an average of 12 hours- 24 days A summary table presenting number, type and duration of ventilator alarms within study population
Hospital mortality through study completion, an average of 12 hours- 24 days Number of bellavista-ventilated patients who died during the hospital admission after the ICU discharge
Analysis of patient-ventilator interactions - Pneumothorax rate through study completion, an average of 12 hours- 24 days Number of confirmed pneumothoraxes during ventilation
Analysis of patient-ventilator interactions - Retinopathy of prematurity through study completion, an average of 12 hours- 24 days Number of patients with retinopathy of prematurity and level
Intraventricular hemorrhage through study completion, an average of 12 hours- 24 days Number of patients with intraventricular hemorrhage
Trial Locations
- Locations (2)
University Health Network
🇨🇦Toronto, Ontario, Canada
University Children's Hospital Zürich
🇨🇭Zürich, Zurich, Switzerland