Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-02-25 @ 4:47 PM
Study NCT ID:
NCT03119727
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2017-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of FreeO2 (Version 4) in All Patients Receiving Oxygen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2017-04-12', 'studyFirstSubmitQcDate': '2017-04-13', 'lastUpdatePostDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% of time in the set SpO2 target', 'timeFrame': 'During 3 days of hospitalization or until Oxygen weaning', 'description': 'Continuous SpO2 monitoring (1 data each second) will be recorded, the % of time within the SpO2 target±2% set by the physician will be considered (Time in the target±2/Total recording time)'}], 'secondaryOutcomes': [{'measure': 'Oxygenation data', 'timeFrame': '3 hospitalisations day or until Oxygen weaning', 'description': 'the % of time with hyperoxia (SpO2 \\> SpO2 target+5%), the % of time with severe hypoxemia (SpO2 \\<85%) the % of time without SpO2 signal, the % of time with oscillations of SpO2 values, comparison of Wired SpO2 vs Bluetooth SpO2, Daily variations of oxygen flows J1, J2 and J3\n\n% Weaning\\> 50% relative baseline,% complete weaning of O2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Disease', 'Respiratory Failure', 'COPD Exacerbation', 'Asthma', 'Pneumonia']}, 'descriptionModule': {'briefSummary': 'Evaluation of automatic titration of oxygen with a new version of FreeO2 (V4)', 'detailedDescription': 'In the previous studies, the investigators used many times automatic titration of oxygen on spontanous breathing patient (FreeO2 device) with a prototype develop in our lab in collaboration with Laval university. In this study, we want to evaluate the new version of the FreeO2 device (V4)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> or = 18 years old\n* Patient receiving oxygen between 1 to 6 lpm for medical pathology\n* Admitted to a medical service for less than 72 hours (emergency room not included)\n\nExclusion Criteria:\n\n* Unreliable SpO2 signal\n* Emergency or intensive care hospitalization\n* Absence of NIV or intubation criteria at baseline\n* Sleep apnea not paired\n* Long-term Oxygen Therapy\n* Active delirium and cognitive impairment preventing informed consent'}, 'identificationModule': {'nctId': 'NCT03119727', 'acronym': 'FreeO24G', 'briefTitle': 'Clinical Evaluation of FreeO2 (Version 4) in All Patients Receiving Oxygen', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Clinical Evaluation of the Automatic Oxygen Adjustment by FreeO2 in a Medical Population in Hospital', 'orgStudyIdInfo': {'id': '21342'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Automated oxygen adjustment', 'description': 'All patient in this study have automatic oxygen titration and automatic oxygen weanning', 'interventionNames': ['Device: FreeO2']}], 'interventions': [{'name': 'FreeO2', 'type': 'DEVICE', 'description': 'All include patients will have automatic administration of oxygen by FreeO2 up to 3 day or until weaning of oxygen adminisatrion', 'armGroupLabels': ['Automated oxygen adjustment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'IUCPQ-UL', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'François Lellouche', 'investigatorAffiliation': 'Laval University'}}}}