Ventilation Therapy; ComplicationsNCT05383651
Post Market, Prospective Multicenter Observational Study of the Safety and Performance of Bellavista Ventilator
An observational study of Ventilation Therapy; Complications, run by Vyaire Medical at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Ventilation Therapy; Complications
- What is being tested?
- bellavista 1000 and bellavista 1000 neo
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Neonates and adults ventilated with Bellavista ventilator in intensive care units.
Who may be able to join
- Patient ventilated with bellavista
- Patient in ICU setting
- Signed informed consent per ethical committee requirements
Who cannot join
- Patients expected to be ventilated less than 12 hours
- The clinical care team does not agree with inclusion of the patient to the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Switzerland1 site
University Children's Hospital Zürich
Zurich, Canton of Zurich, 8032
About this study
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
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.
Read the 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.
- Conditions
- Ventilation Therapy; Complications
- Being tested
- bellavista 1000, bellavista 1000 neo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bellavista 1000Device
observational use of Bellavista 1000 ventilator in adult ventilated patients
bellavista 1000 neoDevice
observational use of Bellavista 1000 ventilator in neonatal ventilated patients
| Study group | Role | What they receive |
|---|---|---|
| Adults | Not described Receives: Device: bellavista 1000 | |
| Pediatric/ Neonates | Not described Receives: Device: bellavista 1000 neo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator Performance - Relationship between the set and observed Positive End-Expiratory Pressure (PEEP)
Difference between set and observed PEEP
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 12 hours- 24 days
Secondary outcomes (16)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Pneumothorax rate
Number of confirmed pneumothoraxes during ventilation
Measured: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Sepsis
Number of patients with sepsis
Measured: 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
Measured: 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
Measured: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Necrotizing enterocolitis
Number of patients with necrotizing enterocolitis
Measured: through study completion, an average of 12 hours- 24 days
Intraventricular hemorrhage
Number of patients with intraventricular hemorrhage
Measured: through study completion, an average of 12 hours- 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start1 Feb 2023
- Primary completion31 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation Therapy; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyaire Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383651
- Sponsor's protocol ID
- 100-P0243
- Status last verified
- Aug 2024
- First submitted
- 21 Apr 2022
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05383651
- Acronym / sponsor ID
- 100-P0243
- Conditions
- Ventilation Therapy; Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Vyaire MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults | – | Device: bellavista 1000 |
| Pediatric/ Neonates | – | Device: bellavista 1000 neo |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Neonates and adults ventilated with Bellavista ventilator in intensive care units.
Key inclusion criteria (3 listed)
- Patient ventilated with bellavista
- Patient in ICU setting
- Signed informed consent per ethical committee requirements
Key exclusion criteria (2 listed)
- Patients expected to be ventilated less than 12 hours
- The clinical care team does not agree with inclusion of the patient to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bellavista 1000observational use of Bellavista 1000 ventilator in adult ventilated patients | Device | Adults |
| bellavista 1000 neoobservational use of Bellavista 1000 ventilator in neonatal ventilated patients | Device | Pediatric/ Neonates |
Primary outcome
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
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
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
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
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
16 secondary outcomes
Ventilator Safety - Device failure rate
Time frame: through study completion, an average of 12 hours- 24 days
Ventilator Safety - Descriptive statistical analysis of all ventilator alarm events
Time frame: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Duration of mechanical ventilation
Time frame: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Reintubation rate
Time frame: through study completion, an average of 12 hours- 24 days
Length of ICU stay
Time frame: through study completion, an average of 12 hours- 24 days
Length of hospital stay
Time frame: through study completion, an average of 12 hours- 24 days
Ventilator Safety - Number of study participants with device related adverse events
Time frame: through study completion, an average of 12 hours- 24 days
Extubation failure
Time frame: through study completion, an average of 12 hours- 24 days
Hospital mortality
Time frame: through study completion, an average of 12 hours- 24 days
Failure of noninvasive treatment
Time frame: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Pneumothorax rate
Time frame: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Sepsis
Time frame: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Bronchopulmonary dysplasia
Time frame: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Retinopathy of prematurity
Time frame: through study completion, an average of 12 hours- 24 days
Analysis of patient-ventilator interactions - Necrotizing enterocolitis
Time frame: through study completion, an average of 12 hours- 24 days
Intraventricular hemorrhage
Time frame: through study completion, an average of 12 hours- 24 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
Related trials for Ventilation Therapy; Complications
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Recruiting
Telerehabilitation Exercise Program for Postoperative Recovery in Lung Cancer.
Lung Neoplasms, Thoracic Surgery Lung
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Active, not recruiting
Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes
Rib Fractures, Blunt Chest Trauma
Recruiting
Effects of Music Therapy, Breathing Exercises, and Virtual Reality on Obstetric Recovery, Pain, and Gastrointestinal Symptoms After Cesarean Section
Cesarean Section, Cesarean Section Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilation Therapy; Complications, run by Vyaire Medical at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.