Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT03883256
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2019-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High Flow Nasal Cannula on Exercise Endurance in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072601', 'term': 'Cannula'}], 'ancestors': [{'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2019-03-10', 'studyFirstSubmitQcDate': '2019-03-18', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'exercise time with high flow nasal cannula', 'timeFrame': 'end of the exercise test in the session of constant-load exercise test with high flow nasal cannula oxygen device', 'description': 'the total duration that subjects performed constant-load exercise test with high flow nasal cannula oxygen device'}, {'measure': 'exercise time with nasal cannula', 'timeFrame': 'end of the exercise test in the session of constant-load exercise test with nasal cannula oxygen device', 'description': 'the total duration that subjects performed constant-load exercise test with nasal cannula oxygen device'}], 'secondaryOutcomes': [{'measure': 'Difference in cardiac output', 'timeFrame': 'Baseline and 48 hours after baseline ]', 'description': 'Difference in end-exercise cardiac output in constant-load exercise test between HFNCO and NC'}, {'measure': 'Difference in stroke volume', 'timeFrame': 'Baseline and 48 hours after baseline ]', 'description': 'Difference in end-exercise stroke volume in constant-load exercise test between HFNCO and NC'}, {'measure': 'Difference in muscle tissue oxygenation', 'timeFrame': 'Baseline and 48 hours after baseline ]', 'description': 'Difference in end-exercise muscle tissue oxygenation in constant-load exercise test between HFNCO and NC'}, {'measure': 'Difference in cerebral tissue oxygenation', 'timeFrame': 'Baseline and 48 hours after baseline ]', 'description': 'Difference in end-exercise cerebral tissue oxygenation in constant-load exercise test between HFNCO and NC'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High flow nasal cannula oxygen', 'exercise performance', 'COPD'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': "Ventilation limitation has a significant adverse effects on cardiovascular function and cerebral oxygenation during exercise in patients with COPD. High flow nasal cannula (HFNC) has been shown to improve ventilation by washing out the anatomical dead space and permitting a better gas exchanges. Moreover, it is able to ensure the desired inspired oxygen fraction (FiO2) even at high level of patient's minute ventilation by minimizing the room air entrainment. The effects of HFNC on exercise performance in terms of hemodynamic changes and exercise endurance in COPD patients remain unclear. The primary purpose of this study is to examine the effects of HFNC on the exercise endurance in COPD patients. The investigator's secondary purpose is to investigate whether HFNC could improve efficiency of ventilation, leading to an improvement of hemodynamic and cerebral oxygenation response.", 'detailedDescription': 'This is a randomized crossover study. Patients who have been diagnosed as COPD will be recruited from outpatient department. After signing informed consent form, patients undertake an incremental exercise test and two constant load exercise at the 70% of maximum workload achieved at a previous incremental exercise test on arm ergometer in two separate days. The constant load tests will be performed with HFNC and with nasal cannula at the same inhaled oxygen fraction in random order. The hemodynamics CO, SV, EF of all subjects during exercises will be measured by a bioelectrical impedance device (Physioflow), and cerebral oxygenation status (oxygenated hemoglobin (O2Hb), deoxygenated hemoglobin (HHb), total hemoglobin (tHb) was measured by a near infrared spectrophotometer (NIRS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. with diagnosis of COPD\n2. OPD patients\n3. has no AE (within 1 month)\n4. not receiving any O2 therapy at home\n5. no smoking or quick\n\nExclusion Criteria:\n\n1. fever\n2. unstable hemodynamics at resting\n3. orthopadeic or neurologic problems that limited exercise'}, 'identificationModule': {'nctId': 'NCT03883256', 'briefTitle': 'High Flow Nasal Cannula on Exercise Endurance in COPD', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung University'}, 'officialTitle': 'Effects of High Flow Nasal Cannula on Exercise Endurance in Patients With COPD', 'orgStudyIdInfo': {'id': '201800540A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'high flow nasal cannula', 'description': 'Subjects perform a constant-load exercise test with high flow nasal cannula oxygen device.', 'interventionNames': ['Device: high flow nasal cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nasal cannula', 'description': 'Subjects perform a constant-load exercise test with nasal cannula oxygen device.', 'interventionNames': ['Device: nasal cannula']}], 'interventions': [{'name': 'high flow nasal cannula', 'type': 'DEVICE', 'description': 'High flow nasal cannula is a device that delivered heated and humidified high flow gases to at or near body temperature to avoid drying and possible injury to the nasal mucosa. In this study, subjects perform a constant-load exercise test with high flow nasal cannula.', 'armGroupLabels': ['high flow nasal cannula']}, {'name': 'nasal cannula', 'type': 'DEVICE', 'description': 'Nasal cannula is a device that delivered oxygen to patients. In this study, subjects perform a constant-load exercise test with nasal cannula.', 'armGroupLabels': ['nasal cannula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan', 'country': 'Taiwan', 'facility': 'Chang Gung University', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}], 'overallOfficials': [{'name': 'Yen-Huey Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Chen Yen-Huey', 'investigatorAffiliation': 'Chang Gung University'}}}}