Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-25 @ 2:37 AM
Study NCT ID:
NCT01166256
Status:
UNKNOWN
Last Update Posted:
2010-07-21
First Post:
2010-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063087', 'term': 'Noninvasive Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'lastUpdateSubmitDate': '2010-07-20', 'studyFirstSubmitDate': '2010-07-19', 'studyFirstSubmitQcDate': '2010-07-20', 'lastUpdatePostDateStruct': {'date': '2010-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of treatment in two groups', 'timeFrame': 'up to 28 days', 'description': 'Successful treatment is to avoid intubation and achieve PaO2 \\>75 mmHg without respiratory distress for 24 hours while spontaneously breathing oxygen provided by a Venturi device at FiO2 0.50.'}], 'secondaryOutcomes': [{'measure': 'compliance of treatment', 'timeFrame': 'up to 28 days', 'description': 'Withdrawl of non-invasive ventilation or high-flow nasal cannula system without intubation because of intolerance'}, {'measure': 'adverse event', 'timeFrame': 'up to 28 days'}, {'measure': 'hospital length of stay', 'timeFrame': 'up to 90 days'}, {'measure': 'Hospital mortality', 'timeFrame': 'up to 90 days'}]}, 'conditionsModule': {'keywords': ['respiratory failure'], 'conditions': ['Acute Hypoxemic Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Acute hypoxemic respiratory failure may require invasive mechanical ventilation. However, invasive mechanical ventilation is associated with a variety of complications. Non-invasive ventilation has been presented as an alternative treatment but controversy remains. The investigators hypothesize that high-flow nasal cannula system is effective enough to prevent intubation in acute hypoxemic respiratory failure and not inferior to non-invasive ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 18\n* patients with acute hypoxemic respiratory failure\n\nExclusion Criteria:\n\n* age \\< 18 years\n* hypercapnia (arterial carbon dioxide tension (PaCO2) \\>45mmHg) at admission\n* need for emergency intubation, including cardiopulmonary resuscitation\n* recent esophageal, facial or cranial trauma or surgery\n* severely decreased consciousness (Glasgow coma score \\<11)\n* cardiogenic shock or severe hemodynamic instability\n* systolic blood pressure \\<90 mmHg associated with decreased urinary output(\\<20 mL.h-1) despite fluid repletion and use of vasoactive agents\n* lack of co-operation\n* altered mental status with decreased consciousness and/or evidence of inability to understand or lack of willingness to co-operate with the procedures\n* tracheotomy or other upper airway disorders\n* severe ventricular arrhythmia or active myocardial ischemia\n* active upper gastrointestinal bleeding\n* inability to clear respiratory secretions\n* more than one severe organ dysfunction in addition to respiratory failure'}, 'identificationModule': {'nctId': 'NCT01166256', 'briefTitle': 'Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Prospective, Open-labeled, Randomized Controlled Trial of Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure', 'orgStudyIdInfo': {'id': 'HFNCinAHRF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-flow nasal cannula', 'description': 'In this arm,patients with acute hypoxemic respiratory failure were treated with high-flow nasal cannula system(Optiflow, Fisher \\& Paykel, Auckland, New Zealand) to achieve SpO2 \\>92% or PaO2 \\>65 mmHg.', 'interventionNames': ['Device: High flow nasal cannula system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-invasive ventilation', 'description': 'In this arm, patients with acute hypoxemic respiratory failure is treated with the bi-level positive airways pressure mode (BiPAP Vision, Respironics Inc., Murrysville, PA) S/T mode to achieve SpO2 \\>92% or PaO2 \\>65 mmHg.', 'interventionNames': ['Device: Non-invasive ventilation']}], 'interventions': [{'name': 'Non-invasive ventilation', 'type': 'DEVICE', 'otherNames': ['(BiPAP Vision, Respironics Inc., Murrysville, PA)'], 'description': 'Noninvasive ventilation: The inspiratory(IPAP) and expiratory positive airways pressure (EPAP), and the levels of FiO2 is set achieve SpO2 \\>92% or PaO2 \\>65 mmHg.', 'armGroupLabels': ['Non-invasive ventilation']}, {'name': 'High flow nasal cannula system', 'type': 'DEVICE', 'otherNames': ['Optiflow(Fisher & Paykel, Auckland, New Zealand)'], 'description': 'High flow nasal cannula system: FiO2 and flow rate of oxygen is set to achieve SpO2 \\>92% or PaO2 \\>65 mmHg.', 'armGroupLabels': ['High-flow nasal cannula']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Woo-hyun Cho, M.D.', 'role': 'CONTACT', 'email': 'popeyes0212@hanmail.net', 'phone': '+82-2-3010-3139'}], 'facility': 'Asan Medical Center, University of Ulsan College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Chae-Man Lim, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Chae-Man Lim', 'oldOrganization': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea'}}}}