Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-27 @ 12:48 AM
Study NCT ID:
NCT03020394
Status:
UNKNOWN
Last Update Posted:
2020-01-18
First Post:
2017-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Support in Severe 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 208}, 'patientRegistry': False}, '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': '2017-01-09', 'studyFirstSubmitQcDate': '2017-01-11', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of ventilator-associated pneumonia (VAP)', 'timeFrame': '90days'}, {'measure': 'The all cause mortality of ICU and hospitalization', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'The length of stay of ICU and hospitalization', 'timeFrame': '90 days'}, {'measure': 'The length of stay of mechanical ventilation', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD Exacerbation', 'Noninvasive Positive Ventilation', 'Invasive Positive Ventilation', 'severe', 'High flow nasal cannula'], 'conditions': ['COPD Exacerbation']}, 'descriptionModule': {'briefSummary': "Preliminary studies have shown that NPPV can avoid tracheal intubation in 40% to 60% patients who have severe exacerbation of COPD. Recently, large-scale comparative effectiveness research (CER) also found that compared with invasive ventilation, NPPV can reduce mortality rates. But there's no high-quality clinical studies which can confirm this. Therefore, investigators believe that NPPV can avoid intubation in patients with severe exacerbation of COPD in ICU with perfect monitoring conditions and reasonable human resource allocation, in order to reduce IMV-related complications and improve patients' outcomes.", 'detailedDescription': "In part of the patients who were AECOPD with pH \\<7.25 , preliminary studies have shown that NPPV can avoid tracheal intubation in 40% to 60% patients, and also reduce the incidence of VAP. Recently, large-scale comparative effectiveness research (CER) also found that compared with invasive ventilation, NPPV can reduce mortality rates. At present, there's no high-quality clinical studies which can confirm this, and clinical guidelines do not have a recommendation on the use of NPPV in these patients. Therefore, investigators believe that NPPV can avoid intubation in patients with severe exacerbation of COPD in ICU with perfect monitoring conditions and reasonable human resource allocation, as well as the progress of medical technology in NPPV in recent years, in order to reduce IMV-related complications and improve patients' outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with acute exacerbation of chronic obstructive pulmonary disease in medical ICU.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AECOPD;\n\nExclusion Criteria:\n\n* refuse to engage in the study;\n* have been included in other study.'}, 'identificationModule': {'nctId': 'NCT03020394', 'briefTitle': 'Respiratory Support in Severe Chronic Obstructive Pulmonary Disease Exacerbation', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Comparison of High Flow Nasal Cannula, Noninvasive Positive Ventilation (NPPV) and Invasive Positive Ventilation (IPPV) in Severe Chronic Obstructive Pulmonary Disease Exacerbation (AECOPD)', 'orgStudyIdInfo': {'id': '2016YFC1304304-3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Noninvasive ventilation', 'description': "Noninvasive positive pressure ventilation is achieved by Philips Respironics V60/Vision ventilator. Choose bilevel positive airway pressure mode, and adjust the fraction of inspire oxygen(FiO2) or oxygen flow rate to maintain patient's oxygen saturation(SpO2) between 88% to 92%. Parameter adjustment and weaning of NPPV follow the protocols used before."}, {'label': 'Invasive ventilation', 'description': 'Intubated immediately and connected to the ventilator. Parameter adjustment and weaning of IPPV follow the protocols used before.'}, {'label': 'High flow nasal cannula', 'description': "High flow nasal cannula of different models (large, medium and small) are selected depending on the size and comfort of the patient's nostrils. Adjusting the oxygen flow rate (O2 Flow) maintains the patient's SpO2 88% to 92%. The flow was initially adjusted to 25 L/min and the flow was gradually adjusted to the patient's maximum tolerance. The inspiratory gas temperature (31 to 37 °C) was set to the patient's maximum tolerance level. If the patient's condition deteriorates and the tracheal intubation standard is met , the patient is recommended to undergo invasive ventilation treatment, but the choice of the final respiratory support method should be decided by the attending physician, patient and family."}]}, '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'}], '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'}}}}