Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-02-24 @ 2:09 PM
Study NCT ID:
NCT03014869
Status:
UNKNOWN
Last Update Posted:
2020-01-18
First Post:
2017-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Flow Nasal Cannula vs NPPV in Moderate Chronic Obstructive Pulmonary Disease Exacerbation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 351}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-13', 'studyFirstSubmitDate': '2017-01-06', 'studyFirstSubmitQcDate': '2017-01-06', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'endotracheal intubation demand rate', 'timeFrame': '90days'}], 'secondaryOutcomes': [{'measure': 'actual endotracheal intubation rate', 'timeFrame': '90days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD Exacerbation', 'High Flow Oxygen', 'Noninvasive Positive Ventilation', 'moderate'], 'conditions': ['COPD Exacerbation']}, 'descriptionModule': {'briefSummary': 'For moderate AECOPD(pH\\<7.35), several guidelines have strongly recommended NPPV as standard therapy, which can reduce the rate of intubation and mortality. A few previous studies have shown that HFNC can efficiently improve alveoli ventilation and breathing pattern in some severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior to NPPV for preventing endotracheal intubation in moderate AECOPD patients. To assess this hypothesis, we performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in moderate AECOPD patients.', 'detailedDescription': 'Recently, many clinical studies have showed that HFNC can be successfully used in patients with hypoxemic respiratory failure to improve the comfort, to attenuate respiratory failure and to decrease the rate of tracheal intubation and mortality. Although theoretically HFNC is a potential and ideal treatment for AECOPD patients, the related clinical researches are very few. It still needs to further evaluate the safety and efficacy of HFNC in patients with AECOPD. For moderate AECOPD(pH\\<7.35), several guidelines have strongly recommended NPPV as standard therapy, which can reduce the rate of intubation and mortality. A few previous studies have shown that HFNC can efficiently improve alveoli ventilation and breathing pattern in some severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior to NPPV for preventing endotracheal intubation in moderate AECOPD patients. To assess this hypothesis, we performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in moderate AECOPD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AECOPD; 7.35\\>pH≥7.25，PaCO2\\>50 mmHg\n\nExclusion Criteria:\n\n* contraindications for NPPV, such as thick sputum, cough weakness, hemodynamic instability, etc.; need to be intubated immediately; refuse to engage in the study; severe organ dysfunction'}, 'identificationModule': {'nctId': 'NCT03014869', 'briefTitle': 'High Flow Nasal Cannula vs NPPV in Moderate Chronic Obstructive Pulmonary Disease Exacerbation', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Comparison of High Flow Nasal Cannula and Noninvasive Positive Ventilation(NPPV) in Moderate Chronic Obstructive Pulmonary Disease Exacerbation(AECOPD)', 'orgStudyIdInfo': {'id': '2016YFC1304304-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High flow nasal cannula', 'description': "High flow nasal cannula(OptiflowTM); Flow 25-60 L/min is set according to patients' comfort; FiO2 is adjusted to maintain peripheral capillary oxygen saturation(SpO2) 90-95%; temperature is set at 37 degree centigrade.", 'interventionNames': ['Device: High flow nasal cannula']}, {'type': 'NO_INTERVENTION', 'label': 'Noninvasive positive ventilation', 'description': 'Parameters are set according to NPPV protocols'}], 'interventions': [{'name': 'High flow nasal cannula', 'type': 'DEVICE', 'otherNames': ['High flow oxygen'], 'description': 'High flow nasal cannula (HFNC) is a new emerging noninvasive respiratory support technology, which mainly includes high flow (15-60 L/min) device, heating humidification device and nasal cannula for high flow. A large number of physiological studies confirmed that HFNC has the following critical physiological effects: promoting airway humidification, improving tolerance of treatment, reducing the physiological dead space on the upper respiratory tract, producing a certain level of positive end expiratory pressure (2-7 cmH2O), decreasing the work of breathing and so on.', 'armGroupLabels': ['High flow nasal cannula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100028', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chen Wang, MD', 'role': 'CONTACT'}], 'facility': 'China-Japan Friendship hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jingen Xia, Master', 'role': 'CONTACT', 'email': 'xiajingen_00632@163.com', 'phone': '13466396561', 'phoneExt': '+86'}], 'overallOfficials': [{'name': 'Qingyuan Zhan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China-Japan Friendship Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of Pulmonary and Critical care medicine ward 4', 'investigatorFullName': 'Qingyuan Zhan', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}