Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-25 @ 5:53 PM
Study NCT ID:
NCT02439333
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2015-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Randomized Study of Nasal High Flow in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-14', 'studyFirstSubmitDate': '2015-05-07', 'studyFirstSubmitQcDate': '2015-05-07', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment failure criteria', 'timeFrame': '5 days', 'description': 'Patients with mild respiratory acidosis (7.25 \\< pH \\< 7.35) with obvious dyspnea (accessory respiratory muscle involvement, breathing rate greater than 25 beats per minute)'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '30 days'}, {'measure': 'Costs of hospitalization expenses', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute exacerbation of chronic obstructive pulmonary disease', 'Nasal high flow therapy', 'Oxygen therapy'], 'conditions': ['Lung Diseases, Obstructive']}, 'referencesModule': {'references': [{'pmid': '33262584', 'type': 'DERIVED', 'citation': 'Li XY, Tang X, Wang R, Yuan X, Zhao Y, Wang L, Li HC, Chu HW, Li J, Mao WP, Wang YJ, Tian ZH, Liu JH, Luo Q, Sun B, Tong ZH. High-Flow Nasal Cannula for Chronic Obstructive Pulmonary Disease with Acute Compensated Hypercapnic Respiratory Failure: A Randomized, Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Nov 24;15:3051-3061. doi: 10.2147/COPD.S283020. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The main oxygen therapy to the patients with acute exacerbation of Chronic obstructive pulmonary disease, who are mild to moderate respiratory insufficiency (arterial blood gas analysis showed pH = 7.35, PO2 \\< 60mmHg,PaCO2\\>45mmHg) or have achieved the traditional noninvasive ventilation support standard but can not tolerate or reject, was nasal catheter, venturi mask and other conventional oxygen therapy. All these inaccurate inhaled oxygen concentration methods with inadequate heating and humidifying lead to poor patient tolerance and adverse reactions such as airway secretions discharge disorders. The high flow nasal respiratory therapy (Nasal high flow, NHF) utilises higher gas flow rates than conventional low-flow oxygen systems. The devices used deliver heated and humidified oxygen at a flow of up to 60 litres per minute via nasal cannulas with low level continous positive airway pressure. This study is a prospective randomized study. AECOPD patients with no severe respiratory failure are treated with NHF and conventional oxygen therapy respectively. The target is that NHF can increase the comfort degree of patients,reduce the rate of endotracheal intubation, and shorten the time of hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AECOPD patients.\n* The results of blood gas analysis showed pH ≥7.35, PO2\\< 60mmHg, PaCO2\\> 45mmHg.\n\nExclusion Criteria:\n\n* The study case has been incorporated into the hospital again.\n* Refused to the NHF therapy.\n* The Glasgow score \\< 8.\n* Severe organ dysfunction (including liver and kidney dysfunction, decompensated acidosis, upper gastrointestinal bleeding, DIC, etc.)'}, 'identificationModule': {'nctId': 'NCT02439333', 'briefTitle': 'Prospective Randomized Study of Nasal High Flow in Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'orgStudyIdInfo': {'id': '2015-KE-63'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nasal high flow therapy', 'description': 'AECOPD patients with no severe respiratory insufficiency are given NHF therapy for at least 15 hours per day.', 'interventionNames': ['Device: Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional oxygen therapy', 'description': 'AECOPD patients with no severe respiratory insufficiency are given conventional oxygen therapy such as nasal catheter or venturi mask for at least 15 hours per day.', 'interventionNames': ['Device: nasal catheter or Venturi mask']}], 'interventions': [{'name': 'Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand)', 'type': 'DEVICE', 'description': 'Nasal high flow therapy', 'armGroupLabels': ['Nasal high flow therapy']}, {'name': 'nasal catheter or Venturi mask', 'type': 'DEVICE', 'description': 'Conventional oxygen therapy', 'armGroupLabels': ['Conventional oxygen therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Department of respiratory and critical care medicine,Beijing Chao-yang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Bing Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Chao Yang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Li Xuyan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'Li Xuyan', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}