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NCT Number: NCT05383651

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

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.

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Key information

Conditions

Ventilation Therapy; Complications

Age range

6 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Health Network, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bellavista 1000

Device

observational use of Bellavista 1000 ventilator in adult ventilated patients

bellavista 1000 neo

Device

observational use of Bellavista 1000 ventilator in neonatal ventilated patients

Primary outcomes

  1. Ventilator Performance - Relationship between the set and observed Positive End-Expiratory Pressure (PEEP)

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

    Difference between set and observed PEEP

  2. Ventilator Performance - Relationship between the set and observed Peak Inspiratory Pressure (PIP)

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

    Difference between set and observed PIP

  3. Ventilator Performance - Relationship between the set and observed Continuous Positive Airway Pressure (CPAP)

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

    Difference between set and observed CPAP

  4. Ventilator Performance - Relationship between the set and observed tidal volume

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

    Difference between set and observed tidal volume

  5. Ventilator Performance - Relationship between the set and observed flow rate

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

    Difference between set and observed flow rate

Secondary outcomes

  1. Ventilator Safety - Device failure rate

    Time frame: 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)

  2. Ventilator Safety - Descriptive statistical analysis of all ventilator alarm events

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

    A summary table presenting number, type and duration of ventilator alarms within study population

  3. Analysis of patient-ventilator interactions - Duration of mechanical ventilation

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

    Number of days under invasive mechanical ventilation

  4. Analysis of patient-ventilator interactions - Reintubation rate

    Time frame: 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

  5. Length of ICU stay

    Time frame: 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)

  6. Length of hospital stay

    Time frame: 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

  7. Ventilator Safety - Number of study participants with device related adverse events

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

    Number of malfunction of the investigational device leading to potential or actual patient harm

  8. Extubation failure

    Time frame: 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

  9. Hospital mortality

    Time frame: 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

  10. Failure of noninvasive treatment

    Time frame: 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.

  11. Analysis of patient-ventilator interactions - Pneumothorax rate

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

    Number of confirmed pneumothoraxes during ventilation

  12. Analysis of patient-ventilator interactions - Sepsis

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

    Number of patients with sepsis

  13. Analysis of patient-ventilator interactions - Bronchopulmonary dysplasia

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

    Need of oxygen or positive airway pressure at 36 weeks corrected age

  14. Analysis of patient-ventilator interactions - Retinopathy of prematurity

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

    Number of patients with retinopathy of prematurity and level

  15. Analysis of patient-ventilator interactions - Necrotizing enterocolitis

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

    Number of patients with necrotizing enterocolitis

  16. Intraventricular hemorrhage

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

    Number of patients with intraventricular hemorrhage

Sponsors and collaborators

Lead sponsor

Vyaire Medical

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 20, 2022
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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