Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 3:52 AM
Study NCT ID:
NCT05097560
Status:
UNKNOWN
Last Update Posted:
2021-10-28
First Post:
2021-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of HFNC on Exercise Capacity Compared to VM in COPD Patients Recovering From Acute Evacerbation
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-16', 'studyFirstSubmitDate': '2021-10-16', 'studyFirstSubmitQcDate': '2021-10-16', 'lastUpdatePostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endurance time', 'timeFrame': '10 minute', 'description': 'Endurance time for 10 minute steping test'}], 'secondaryOutcomes': [{'measure': 'Respiratory pattern', 'timeFrame': '10 minute', 'description': 'Respiratory pattern is calculated by the flow and time'}, {'measure': 'Work of breathing', 'timeFrame': '10 minute', 'description': 'Work of breathing is calculated by the transdiaphragmatic pressure'}, {'measure': 'Neural respiratory drive', 'timeFrame': '10 minute', 'description': 'Neural respiratory drive is calculated by diaphragm electromyogram'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HFNC', 'PR'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'Early PR is thought to be effective in COPD patients recovering from acute exacerbation, while the effect of HFNC during exercise training in these patients remains unclear. The study may provide evidence of early PR in COPD patients recovering from acute exacerbation.', 'detailedDescription': 'We hypothesize that HFNC may increases exercise time in COPD patients recovering from acute exacerbation compare to VM. A randomized, cross-over clinical trial in which either HFNC or VM may be used as an adjunct in 10-MST in random order, respectively, will be performed to compare the endurance time. The physiological effect of HFNC and VM during exercise will also be measured to explore the mechanism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hospitalized AECOPD patients\n* be ambulatory by 48h after admission for AECOPD\n* requires oxygen by screening exercise test\n\nExclusion Criteria:\n\n* active coronary ischemia\n* respiratory diseases other than COPD\n* unstable vital signs\n* unstable psychological status'}, 'identificationModule': {'nctId': 'NCT05097560', 'briefTitle': 'The Effect of HFNC on Exercise Capacity Compared to VM in COPD Patients Recovering From Acute Evacerbation', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'The Effect of High Flow Nasal Cannula on Exercise Capacity Compared to Venturi Mask in COPD Patients Recovering From Acute Evacerbation', 'orgStudyIdInfo': {'id': 'FAHGZ-20210811'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HFNC group', 'description': '* Set FiO2 28%\n* Titrate the flow of HFNC at the highest tolerated value up to 60 L/min', 'interventionNames': ['Device: high flow nasal cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VM group', 'description': '\\- Keep FiO2 constant with VM and HFNC during the two trial', 'interventionNames': ['Device: Venturi mask']}], 'interventions': [{'name': 'high flow nasal cannula', 'type': 'DEVICE', 'description': 'HFNC provides humidified, heated, oxygen-enriched air at constant concentration with a flow up to 60L/min through a nasal cannula. It washouts the anatomical dead space and decreases the work of breathing.', 'armGroupLabels': ['HFNC group']}, {'name': 'Venturi mask', 'type': 'DEVICE', 'description': 'VM is commonly used by COPD patients during exercise training.', 'armGroupLabels': ['VM group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shiying Fang, MD', 'role': 'CONTACT', 'email': 'fangshiying2019@126.com', 'phone': '+8602083062882'}, {'name': 'Rongchang Chen, PhD', 'role': 'CONTACT', 'email': 'chenrc@vip.163.com', 'phone': '+8613902273260'}], 'facility': 'Shiying', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Shiying Fang, MD', 'role': 'CONTACT', 'email': 'fangshiying2019@126.com', 'phone': '+8602083062882'}], 'overallOfficials': [{'name': 'Rongchang Chen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shiying Fang', 'investigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}}}}