Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT05267418
Status:
TERMINATED
Last Update Posted:
2022-03-04
First Post:
2022-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Automated Oxygen Titration Alone or With High Flow Nasal Therapy on Dyspnea and Exercise Tolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The participant was not inform about what kind of oxygen support was provided during exercise'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'COVID19 pandemia', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-02', 'studyFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2022-03-02', 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean pulsed O2 saturation (SpO2) during 3min-CSST', 'timeFrame': 'From the beginning to the end of the 3 minute-constant speed shuttle test which will be done on 3 testing days with either fixed O2, automatic O2 adjustment alone, or automatic O2 adjustment + high nasal flow)', 'description': 'The mean % pulsed O2 saturation (SpO2) during the test duration time'}, {'measure': 'Capillary blood gases', 'timeFrame': 'Difference the baseline capillary PCO2 from the resting values (before Endurance Shuttle Walking Test - ESWT) to the end of exercise values (after the Endurance Shuttle Walking Test - ESWT) immediately after the intervention', 'description': 'Carbon dioxide partial pressure (PCO2), lactate'}], 'primaryOutcomes': [{'measure': 'Dyspnea score', 'timeFrame': 'At the end of the 3 minute-constant speed shuttle test (CSST) (3 minutes), immediately after the intervention (either fixed-O2, automated nasal O2 adjustment alone, or automated nasal O2 adjustment + high nasal flow)', 'description': 'Dyspnea score on the modified Borg scale (0 to 10, with higher score indicating worse dyspnea)'}], 'secondaryOutcomes': [{'measure': 'Endurance time duration of the Endurance Shuttle Walking Test (EWST)', 'timeFrame': 'Duration in (mm:ss) of Endurance Shuttle Walking Test (ESWT), immediately after the intervention (either fixed-O2, automated nasal O2 adjustment alone, or automated nasal O2 adjustment + high nasal flow)', 'description': 'Total duration of Endurance Shuttle Walking Test'}, {'measure': 'Mean pulsed O2 saturation (SpO2) during Endurance Shuttle Walking Test (EWST)', 'timeFrame': 'From the beginning to the end of the Endurance Shuttle Walking Test (ESWT) which will be done on 3 testing days, with either fixed O2, automatic O2 adjustment alone, or automatic O2 adjustment + high nasal flow', 'description': 'Mean % pulsed O2 saturation (SpO2) during the Endurance Shuttle Walking Test (ESWT)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyspnea', 'Lung Diseases', 'Pulmonary Hypertension', 'Chronic Obstructive Pulmonary Disease', 'Cystic Fibrosis', 'Interstitial Lung Disease']}, 'referencesModule': {'references': [{'pmid': '30655277', 'type': 'BACKGROUND', 'citation': "Maltais F, Aumann JL, Kirsten AM, Nadreau E, Macesic H, Jin X, Hamilton A, O'Donnell DE. Dual bronchodilation with tiotropium/olodaterol further reduces activity-related breathlessness versus tiotropium alone in COPD. Eur Respir J. 2019 Mar 28;53(3):1802049. doi: 10.1183/13993003.02049-2018. Print 2019 Mar."}, {'pmid': '32663102', 'type': 'BACKGROUND', 'citation': "Beaulieu J, Jensen D, O'Donnell DE, Brouillard C, Tracey L, Vincent S, Nadreau E, Bernard E, Bernard S, Maltais F. Relieving exertional dyspnea during the 3-min constant speed shuttle test in patients with COPD with indacaterol/glycopyrronium versus tiotropium: the RED trial. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620939507. doi: 10.1177/1753466620939507."}, {'pmid': '19863362', 'type': 'BACKGROUND', 'citation': 'Perrault H, Baril J, Henophy S, Rycroft A, Bourbeau J, Maltais F. Paced-walk and step tests to assess exertional dyspnea in COPD. COPD. 2009 Oct;6(5):330-9. doi: 10.1080/15412550903156317.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the effects of automated oxygen administration (FreeO2 system) alone or with high-flow oxygen on dyspnea and exercise tolerance in people with desaturating chronic lung disease compared to fixed oxygen therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOne of them\n\n* Moderate to severe COPD (forced expiratory volume in 1 second (FEV1) \\< 80% predicted and FEV1/forced vital capacity (FVC) ratio \\< 0.7)\n* Chronic interstitial lung disease such as usual interstitial pneumonitis (UIP), non-specific interstitial pneumonitis (NSIP) or hypersensitivity pneumonitis on high-resolution computed tomography\n* Pulmonary arterial hypertension type 1 or 4, excluding involvement secondary to collagenosis as well as secondary to congenital heart disease, as diagnosed with mean pulmonary artery pressure \\> 25 mm Hg at right heart catheterization\n* Cystic fibrosis, as diagnosed by a positive sweat test (\\>60 mmol/L) or having 2 genetic mutations known to cause cystic fibrosis.\n\nAND having a 6-minute walking test with significant desaturation defined as a decrease in O2 saturation greater or equal to 5% with O2 saturation at the end of the walking test \\< 88%\n\nExclusion Criteria:\n\n* Exacerbation of the primary lung disease in the past 8 weeks\n* Exercise limiting diseases other than the primary lung disease.\n* Not reaching the target dyspnea score during the walking tests.\n* Stage 1 pulmonary sarcoidosis\n* History of syncope on exertion\n* SpO2 with effort less than 90% despite the use of 6 L of O2 per minute\n* Cardiac condition deemed unstable or severe (e.g. severe aortic stenosis)\n* Disabling or severe rheumatological or neurological condition\n* Participation in a pulmonary rehabilitation program within the last year\n* Patients with multi-resistant bacteria'}, 'identificationModule': {'nctId': 'NCT05267418', 'briefTitle': 'Effects of Automated Oxygen Titration Alone or With High Flow Nasal Therapy on Dyspnea and Exercise Tolerance', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Effects of Automated Oxygen Titration Alone or With High Flow Nasal Therapy on Dyspnea and Exercise Tolerance in Patients With Desaturating Chronic Lung Disease: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '21726'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'automated nasal oxygen titration with FreeO2 alone', 'description': 'The participant received automated nasal oxygen titration administered by a closed loop system (FreeO2) during the 3-min constant speed shuttle test (3-min CSST) and endurance shuttle walking test (ESWT). The objective of this system is maintain SpO2 a the pre-specified target level (94% in this study) with an automatic adjustment of oxygen flow second by second.', 'interventionNames': ['Device: Automated nasal O2 titration with FreeO2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'automated nasal oxygen titration with FreeO2 with high-flow nasal O2 therapy', 'description': 'In addition to nasal oxygen titration administered by a closed loop system (FreeO2), the participant received high flow nasal therapy (Airvo2) set at 60 liters per minute with nasal canula during the 3-min CSST and endurance shuttle walking test.', 'interventionNames': ['Device: Automated nasal O2 titration with FreeO2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fixed-flow oxygen therapy', 'description': 'The participant received oxygen by nasal canula at a fixed flow of 2 liters per minute during the 3-min constant speed shuttle test (3-min CSST) and endurance shuttle walking test (ESWT). In patients already on home oxygen, the O2 flow during exercise was set at 1 L/min above the usual flow used at home .', 'interventionNames': ['Device: Automated nasal O2 titration with FreeO2']}], 'interventions': [{'name': 'Automated nasal O2 titration with FreeO2', 'type': 'DEVICE', 'otherNames': ['High O2 nasal flow with Airvo2', 'Fixed O2 flow'], 'description': 'The participant received, in a randomized, cross-over study design: 1) automated nasal oxygen titration administered by a closed loop system (FreeO2) alone, 2) or with high flow nasal therapy (Airvo2) set at 60 liters per minute with nasal canula, or 3) oxygen by nasal canula at a fixed flow of 2 liters per minute during the 3-min constant speed shuttle test (3-min CSST) and endurance shuttle walking test (ESWT)', 'armGroupLabels': ['Fixed-flow oxygen therapy', 'automated nasal oxygen titration with FreeO2 alone', 'automated nasal oxygen titration with FreeO2 with high-flow nasal O2 therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Francois Maltais', 'investigatorAffiliation': 'Laval University'}}}}