Post Market, Prospective Multicenter Observational Study of the Safety and Performance of Bellavista Ventilator

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ventilation Therapy; Complications

Intervention / Treatment
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* Device: bellavista 1000
* Device: bellavista 1000 neo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults<br> | Device: bellavista 1000<br>* observational use of Bellavista 1000 ventilator in adult ventilated patients<br>|
| Pediatric/ Neonates<br> | Device: bellavista 1000 neo<br>* observational use of Bellavista 1000 ventilator in neonatal ventilated patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator Performance - Relationship between the set and observed Positive End-Expiratory Pressure (PEEP) | Difference between set and observed PEEP | 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 | 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 | 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 | 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 | through study completion, an average of 12 hours- 24 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | through study completion, an average of 12 hours- 24 days | 
| Ventilator Safety - Descriptive statistical analysis of all ventilator alarm events | A summary table presenting number, type and duration of ventilator alarms within study population | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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. | through study completion, an average of 12 hours- 24 days | 
| Analysis of patient-ventilator interactions - Pneumothorax rate | Number of confirmed pneumothoraxes during ventilation | through study completion, an average of 12 hours- 24 days | 
| Analysis of patient-ventilator interactions - Sepsis | Number of patients with sepsis | 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 | 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 | through study completion, an average of 12 hours- 24 days | 
| Analysis of patient-ventilator interactions - Necrotizing enterocolitis | Number of patients with necrotizing enterocolitis | through study completion, an average of 12 hours- 24 days | 
| Intraventricular hemorrhage | Number of patients with intraventricular hemorrhage | through study completion, an average of 12 hours- 24 days |