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

NCT05383651 | Completed

• 1 other identifier: 100-P0243
• Study Type: observational
• Target: 350
• Locations: 2 countries
• Sites: 2

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.

Conditions

Ventilation Therapy; Complications

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (16)

• Ventilator Safety - Device failure rate

  through study completion, an average of 12 hours- 24 days

• Ventilator Safety - Descriptive statistical analysis of all ventilator alarm events

  through study completion, an average of 12 hours- 24 days

• Analysis of patient-ventilator interactions - Duration of mechanical ventilation

  through study completion, an average of 12 hours- 24 days

• Analysis of patient-ventilator interactions - Reintubation rate

  through study completion, an average of 12 hours- 24 days

• Length of ICU stay

  through study completion, an average of 12 hours- 24 days

Study Arms (2)

Adults

Device: bellavista 1000

Pediatric/ Neonates

Device: bellavista 1000 neo

Interventions

bellavista 1000 DEVICE

observational use of Bellavista 1000 ventilator in adult ventilated patients

Adults

bellavista 1000 neo DEVICE

observational use of Bellavista 1000 ventilator in neonatal ventilated patients

Pediatric/ Neonates

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patient ventilated with bellavista
• Patient in ICU setting
• Signed informed consent per ethical committee requirements

You may not qualify if:

• Patients expected to be ventilated less than 12 hours

Sponsors & Collaborators

• Vyaire Medical: lead

Study Sites (2)

University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

University Children's Hospital Zürich

Zurich, Canton of Zurich, 8032, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 20, 2022
• Study Start: February 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-08

Locations

CH (1); CA (1)