Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2026-03-05 @ 10:32 AM
Study NCT ID:
NCT02150434
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
2014-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Automatic Oxygen Flow Titration During Walking in Patients With COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058868', 'term': 'Compressed Air'}, {'id': 'D000388', 'term': 'Air'}, {'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-28', 'studyFirstSubmitDate': '2014-05-26', 'studyFirstSubmitQcDate': '2014-05-28', 'lastUpdatePostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physiological parameters', 'timeFrame': 'during ESWT', 'description': 'Physiological parameters continuously recorded by the FreeO2 system (SpO2, end-tidal CO2 \\[EtCO2\\], respiratory rate, heart rate and oxygen flow when automated oxygen titration was activated), blood gases (before and after ESWT and after recovery) and dyspnea assessment during ESWT with a 10-point Borg scale'}], 'primaryOutcomes': [{'measure': 'Time within predefined SpO2 target', 'timeFrame': 'during exercise (Endurance shuttle walking test)', 'description': 'The primary outcome of the study was the percentage of exercise time during which patients were kept within the SpO2 target of 92 to 96%'}], 'secondaryOutcomes': [{'measure': 'Exercise tolerance', 'timeFrame': 'duration of ESWT', 'description': 'Endurance shuttle walking test time and distance'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oxygen therapy', 'Hypoxemia', 'COPD', 'Closed-loop', 'Automated titration,'], 'conditions': ['COPD', 'Exercise', 'Endurance Shuttle Walking Test (Exercise at 85% of Maximal Shuttle Walking Test)']}, 'referencesModule': {'references': [{'pmid': '27794080', 'type': 'DERIVED', 'citation': "Lellouche F, L'Her E, Bouchard PA, Brouillard C, Maltais F. Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Respir Care. 2016 Nov;61(11):1456-1464. doi: 10.4187/respcare.04406. Epub 2016 Oct 18."}]}, 'descriptionModule': {'briefSummary': 'The aim of the current study was to evaluate a new system (FreeO2) that automatically titrates oxygen flow to maintain stable SpO2, in patients with moderate or severe chronic obstructive pulmonary disease during exercise. The investigators hypothesized that continuous automatic adjustment of the oxygen flows during exercise would better maintain patients within the oxygenation target, reduce episodes of desaturation and hyperoxia and would improve walking exercise tolerance in comparison with fixed levels of low-flow oxygen and with compressed air breathing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 40 years\n* Moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease guidelines\n* Who did not require long-term oxygen therapy were included in the study.\n* Patients were also selected on the basis of known (end-exercise SpO2 \\< 90% on a previous exercise test) or suspected (SpO2 \\< 95% at rest) desaturation during exercise\n\nExclusion Criteria:\n\n* Episode of exacerbation or hospitalisation within last four weeks\n* Current medical condition that could influence exercise tolerance'}, 'identificationModule': {'nctId': 'NCT02150434', 'acronym': 'FreeO2rehab', 'briefTitle': 'Evaluation of Automatic Oxygen Flow Titration During Walking in Patients With COPD', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Evaluation of Automatic Oxygen Flow Titration During Walking in Patients With COPD', 'orgStudyIdInfo': {'id': 'FreeO2-Rehab-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Compressed Air', 'description': 'compressed air delivered at a fixed flow of 2 L/min', 'interventionNames': ['Drug: Compressed air']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxygen constant flow', 'description': 'oxygen delivered at a fixed flow of 2L/min', 'interventionNames': ['Drug: Oxygen constant flow']}, {'type': 'EXPERIMENTAL', 'label': 'Automated oxygen titration', 'description': 'oxygen at a variable flows delivered by the FreeO2', 'interventionNames': ['Device: Automated oxygen titration']}], 'interventions': [{'name': 'Automated oxygen titration', 'type': 'DEVICE', 'otherNames': ["FreeO2 system TM, Oxy'nov.inc"], 'description': 'Automated oxygen titration every second to maintain stable SpO2 at a predefined value (94% in the present study)', 'armGroupLabels': ['Automated oxygen titration']}, {'name': 'Compressed air', 'type': 'DRUG', 'otherNames': ['Air'], 'description': 'compressed air delivered at a fixed flow of 2 L/min', 'armGroupLabels': ['Compressed Air']}, {'name': 'Oxygen constant flow', 'type': 'DRUG', 'otherNames': ['Oxygen'], 'description': 'oxygen delivered at a fixed flow of 2L/min', 'armGroupLabels': ['Oxygen constant flow']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre de recherche de l'IUCPQ", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'François Lellouche, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre de recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonds de la Recherche en Santé du Québec', 'class': 'OTHER_GOV'}, {'name': 'Canada Foundation for Innovation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}