Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-02 @ 6:36 AM
Study NCT ID:
NCT05383651
Status:
COMPLETED
Last Update Posted:
2024-09-05
First Post:
2022-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market, Prospective Multicenter Observational Study of the Safety and Performance of Bellavista Ventilator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2022-04-21', 'studyFirstSubmitQcDate': '2022-05-16', 'lastUpdatePostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventilator Performance - Relationship between the set and observed Positive End-Expiratory Pressure (PEEP)', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Difference between set and observed PEEP'}, {'measure': 'Ventilator Performance - Relationship between the set and observed Peak Inspiratory Pressure (PIP)', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Difference between set and observed PIP'}, {'measure': 'Ventilator Performance - Relationship between the set and observed Continuous Positive Airway Pressure (CPAP)', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Difference between set and observed CPAP'}, {'measure': 'Ventilator Performance - Relationship between the set and observed tidal volume', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Difference between set and observed tidal volume'}, {'measure': 'Ventilator Performance - Relationship between the set and observed flow rate', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Difference between set and observed flow rate'}], 'secondaryOutcomes': [{'measure': 'Ventilator Safety - Device failure rate', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'malfunction of the ventilators necessitating removal of a patient to another ventilation mode or ventilator (bellavista technical alarms with ID higher than 300)'}, {'measure': 'Ventilator Safety - Descriptive statistical analysis of all ventilator alarm events', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'A summary table presenting number, type and duration of ventilator alarms within study population'}, {'measure': 'Analysis of patient-ventilator interactions - Duration of mechanical ventilation', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Number of days under invasive mechanical ventilation'}, {'measure': 'Analysis of patient-ventilator interactions - Reintubation rate', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Number of patients with the need of reintubation, considered by the physician in charge of the patients, after a scheduled or unplanned extubation'}, {'measure': 'Length of ICU stay', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Period of time that the bellavista-ventilated patients spend in the ICU before being discharged (alive or died)'}, {'measure': 'Length of hospital stay', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Period of time that the bellavista-ventilated patients spend in the hospital after ICU discharge'}, {'measure': 'Ventilator Safety - Number of study participants with device related adverse events', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Number of malfunction of the investigational device leading to potential or actual patient harm'}, {'measure': 'Extubation failure', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Defined as the need of reintubation within the first 48 hours from a scheduled extubation'}, {'measure': 'Hospital mortality', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Number of bellavista-ventilated patients who died during the hospital admission after the ICU discharge'}, {'measure': 'Failure of noninvasive treatment', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': '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.'}, {'measure': 'Analysis of patient-ventilator interactions - Pneumothorax rate', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Number of confirmed pneumothoraxes during ventilation'}, {'measure': 'Analysis of patient-ventilator interactions - Sepsis', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Number of patients with sepsis'}, {'measure': 'Analysis of patient-ventilator interactions - Bronchopulmonary dysplasia', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Need of oxygen or positive airway pressure at 36 weeks corrected age'}, {'measure': 'Analysis of patient-ventilator interactions - Retinopathy of prematurity', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Number of patients with retinopathy of prematurity and level'}, {'measure': 'Analysis of patient-ventilator interactions - Necrotizing enterocolitis', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Number of patients with necrotizing enterocolitis'}, {'measure': 'Intraventricular hemorrhage', 'timeFrame': 'through study completion, an average of 12 hours- 24 days', 'description': 'Number of patients with intraventricular hemorrhage'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventilation Therapy; Complications']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nVentilator 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Neonates and adults ventilated with Bellavista ventilator in intensive care units.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient ventilated with bellavista\n* Patient in ICU setting\n* Signed informed consent per ethical committee requirements\n\nExclusion Criteria:\n\n* Patients expected to be ventilated less than 12 hours\n* The clinical care team does not agree with inclusion of the patient to the study'}, 'identificationModule': {'nctId': 'NCT05383651', 'briefTitle': 'Post Market, Prospective Multicenter Observational Study of the Safety and Performance of Bellavista Ventilator', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vyaire Medical'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '100-P0243'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults', 'interventionNames': ['Device: bellavista 1000']}, {'label': 'Pediatric/ Neonates', 'interventionNames': ['Device: bellavista 1000 neo']}], 'interventions': [{'name': 'bellavista 1000', 'type': 'DEVICE', 'description': 'observational use of Bellavista 1000 ventilator in adult ventilated patients', 'armGroupLabels': ['Adults']}, {'name': 'bellavista 1000 neo', 'type': 'DEVICE', 'description': 'observational use of Bellavista 1000 ventilator in neonatal ventilated patients', 'armGroupLabels': ['Pediatric/ Neonates']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '8032', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': "University Children's Hospital Zürich", 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vyaire Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}