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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ventilation Therapy; Complications
• Intervention / Treatment: Device: bellavista 1000; Device: bellavista 1000 neo

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.

• Study Type: Observational
• Enrollment (Anticipated): 350

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neonates and adults ventilated with Bellavista ventilator in intensive care units.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults	Device: bellavista 1000; observational use of Bellavista 1000 ventilator in adult ventilated patients
Pediatric/ Neonates	Device: bellavista 1000 neo; observational use of Bellavista 1000 ventilator in neonatal ventilated patients

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vyaire Medical

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 100-P0243

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No