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

Ventilation Therapy; Complications Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05383651
• Other study ID #: 100-P0243
• Status: Not yet recruiting
• Start date: November 2022
• Est. completion date: March 2024

Study information

• Verified date: November 2022
• Source: Vyaire Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: March 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Ventilation Therapy; Complications

Intervention

Device:
• bellavista 1000
observational use of Bellavista 1000 ventilator in adult ventilated patients
• bellavista 1000 neo
observational use of Bellavista 1000 ventilator in neonatal ventilated patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vyaire Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Analysis of patient-ventilator interactions - Pneumothorax rate	Number of confirmed pneumothoraxes during ventilation	through study completion, an average of 12 hours- 24 days
Secondary	Analysis of patient-ventilator interactions - Sepsis	Number of patients with sepsis	through study completion, an average of 12 hours- 24 days
Secondary	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
Secondary	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
Secondary	Analysis of patient-ventilator interactions - Necrotizing enterocolitis	Number of patients with necrotizing enterocolitis	through study completion, an average of 12 hours- 24 days
Secondary	Intraventricular hemorrhage	Number of patients with intraventricular hemorrhage	through study completion, an average of 12 hours- 24 days