Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-01-02 @ 11:36 PM
Study NCT ID:
NCT03246893
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2017-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of HFNC Versus NIV for Prevent Reintubation in Sepsis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2017-08-03', 'studyFirstSubmitQcDate': '2017-08-08', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device failure rate', 'timeFrame': 'an average of 1 year', 'description': 'Device failure to prevent reintubation, patient discomfort, change to another device within 72 hours after extubation'}], 'secondaryOutcomes': [{'measure': 'Reintubation rate', 'timeFrame': 'an average of 1 year', 'description': 'Patient develope respiratory failure, requiring reintubation within 72 hours after extubation'}, {'measure': '28 day mortality rate', 'timeFrame': 'Upto 28 days', 'description': 'Proportion of dead patients to overall patients'}, {'measure': 'Hospital mortality rate', 'timeFrame': 'an average of 1 year', 'description': 'Proportion of dead patients to overall patients from extubation to discharge date'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sepsis', 'Septic shock', 'Severe sepsis', 'Extubation', 'Reintubation', 'Noninvasive positive pressure ventilation', 'High flow oxygen nasal cannula'], 'conditions': ['Post Extubation Respiratory Failure', 'Re-intubation', 'Septic Shock', 'Severe Sepsis']}, 'referencesModule': {'references': [{'pmid': '26903338', 'type': 'BACKGROUND', 'citation': 'Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.'}, {'pmid': '34523035', 'type': 'DERIVED', 'citation': 'Tongyoo S, Tantibundit P, Daorattanachai K, Viarasilpa T, Permpikul C, Udompanturak S. High-flow nasal oxygen cannula vs. noninvasive mechanical ventilation to prevent reintubation in sepsis: a randomized controlled trial. Ann Intensive Care. 2021 Sep 14;11(1):135. doi: 10.1186/s13613-021-00922-5.'}]}, 'descriptionModule': {'briefSummary': 'Post extubation respiratory failure occur in 30% of extubated patients. More than 50% of them required reintubation. Noninvasive positive pressure ventilation (NIV) had been reported as an effective tool to prevent post extubation respiratory failure. Recently, high flow oxygen nasal cannula (HFNC) had been successfully used to prevent post extubation respiratory failure and prevent reintubation in comparable with NIV among post cardiothoracic surgery and high risk for reintubated patients. There was no information about HFNC versus NIV in prevention of reintubation among severe sepsis or septic shock patients.', 'detailedDescription': 'Post extubation respiratory failure occur in 30% of extubated patients. More than 50% of them required reintubation. Noninvasive positive pressure ventilation (NIV) had been reported as an effective tool to prevent post extubation respiratory failure. Recently, high flow oxygen nasal cannula (HFNC) had been successfully used to prevent post extubation respiratory failure and prevent reintubation. The results from recent randomized controlled trials, comparing HFNC with NIV for prevent post extubation respiratory failure among post cardiac surgery and high risk patients, showed no significant different in the treatment outcome.comparable with NIV among post cardiothoracic surgery and high risk for reintubated patients.\n\nAbout 40-85% of severe sepsis/septic shock patients developed acute respiratory failure, required endotracheal intubation. According to the nature of patients population, usually eldery, multiple co-morbid condition and high APACHE II score, sepsis patients were considerred as high risk for reintubation, after extubated. There was no information about HFNC versus NIV in prevention of reintubation among severe sepsis or septic shock patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of sepsis or septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)\n* Depended on mechanical ventilator for more than 48 hours\n* Plan for extubation due to successful weaning\n\nExclusion Criteria:\n\n* Patient with tracheostomy\n* Recent upper abdominal surgery\n* Wound at face that prohibit face-mask application\n* Patient or 1st degree relative not agree to participate trial\n* Physician prefer either NIV or HFNC for the patient'}, 'identificationModule': {'nctId': 'NCT03246893', 'briefTitle': 'Efficacy of HFNC Versus NIV for Prevent Reintubation in Sepsis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Efficacy of High Flow Oxygen Nasal Cannula Versus Noninvasive Positive Pressure Ventilation After Extubation in Sepsis Patients', 'orgStudyIdInfo': {'id': 'Si212/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Noninvasive positive pressure ventilation', 'description': 'After extubation, patient will receive non invasive positive pressure ventilation (NIV) for prevent respiratory and reintubation', 'interventionNames': ['Device: Noninvasive positive pressure ventilation']}, {'type': 'EXPERIMENTAL', 'label': 'High flow oxygen nasal cannula', 'description': 'After extubation, patient will receive high flow oxygen cannula for prevent respiratory and reintubation', 'interventionNames': ['Device: High flow oxygen nasal cannula']}], 'interventions': [{'name': 'Noninvasive positive pressure ventilation', 'type': 'DEVICE', 'otherNames': ['NIV'], 'description': 'Noninvasive positive pressure ventilation will apply via a face mask with initial setting as the following:\n\nInspiratory pressure 6-8 cmH2O Expiratory pressure 3-5 cmH2O FiO2 30-60% Respiratory rate 12-16 per min', 'armGroupLabels': ['Noninvasive positive pressure ventilation']}, {'name': 'High flow oxygen nasal cannula', 'type': 'DEVICE', 'otherNames': ['HFNC'], 'description': 'High flow oxygen nasal cannula will apply to patient via a nasal cannula with initial setting as the following:\n\nTemperature 37 degree celsius Flow 30 liter per min FiO2 40-60%', 'armGroupLabels': ['High flow oxygen nasal cannula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Surat Tongyoo, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Surat Tongyoo', 'investigatorAffiliation': 'Mahidol University'}}}}