Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-01-10 @ 9:51 AM
Study NCT ID:
NCT04564859
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2020-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficiency of HHHFNC Between Unheated Oxygen Therapy in Difficult Weaning Patients After Extubation in RCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-21', 'studyFirstSubmitDate': '2020-09-13', 'studyFirstSubmitQcDate': '2020-09-21', 'lastUpdatePostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Re-intubation rate', 'timeFrame': 'within 72 hours of extubation', 'description': 'Any placement of an endotracheal tube for any indication within 72 hours of extubation, censored at the first of hospital discharge or 72 hours after extubation.'}], 'secondaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': 'up to 3 months', 'description': 'Mortality rate, or death rate is a measure of the number of deaths'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critically Illness']}, 'referencesModule': {'references': [{'pmid': '36949116', 'type': 'DERIVED', 'citation': 'Tseng CW, Chao KY, Wu HL, Lin CC, Hsu HS. Effectiveness of high-flow nasal cannulae compared with noninvasive positive-pressure ventilation in preventing reintubation in patients receiving prolonged mechanical ventilation. Sci Rep. 2023 Mar 22;13(1):4689. doi: 10.1038/s41598-023-31444-8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of Heated Humidified High-Flow Nasal Cannula compared with noninvasive positive-pressure ventilation in the prevention of extubation failure in patients with prolonged mechanical ventilation.', 'detailedDescription': 'There have been many clinical trials comparing the role of Heated Humidified High-Flow Nasal Cannula or Noninvasive positive pressure ventilation in the prevention of extubation failure.\n\nThese review all have similar results summarized here:\n\nCompared with Noninvasive positive pressure ventilation, Heated Humidified High-Flow Nasal Cannula provides better patient comfort, fewer oxygen desaturation episodes, lower likelihood of interface displacement, and, lower reintubation rate than Noninvasive positive pressure ventilation.\n\nHowever, most of these clinical trials focused on participants experiencing acute respiratory failure.\n\nInvestigators of this study want to find something difference between oh these two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: Over 20 years of age\n* the requirement of at least six hours of mechanical ventilation per day for at least 14 consecutive days\n\nExclusion Criteria:\n\n* Pregnancy\n* Status post tracheostomy\n* Neuromuscular diseases\n* Signed "do not resuscitate" order\n* Unplanned extubation'}, 'identificationModule': {'nctId': 'NCT04564859', 'acronym': 'HHHFNC', 'briefTitle': 'The Efficiency of HHHFNC Between Unheated Oxygen Therapy in Difficult Weaning Patients After Extubation in RCC', 'organization': {'class': 'OTHER', 'fullName': 'Shin Kong Wu Ho-Su Memorial Hospital'}, 'officialTitle': 'The Efficiency of Heated Humidifier High-Flow Nasal Cannula Between Unheated Oxygen Therapy in Difficult Weaning Patients After Extubation in Respiratory Care Center', 'orgStudyIdInfo': {'id': 'SKH-8302-106-NDR-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Noninvasive Ventilation group', 'description': 'Noninvasive Ventilation group initial setting： Insp. Pressure：12 \\~ 16 centimeter of water Exp. Pressure ： 4 \\~ 6 centimeter of water FiO2：Keep oxygen saturation measured by pulse oximeter：\\> 92% By condition, gradually tap 2\\~3 centimeter of water inspiratory positive airway pressure Keep Tidal volume：6\\~10 ml/kg', 'interventionNames': ['Device: Heated Humidified High-Flow Nasal Cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heated Humidified High-Flow Nasal Cannula group', 'description': 'Heated Humidified High-Flow Nasal Cannula group initial setting： Flow setting: 50 L/m FiO2：Keep oxygen saturation measured by pulse oximeter \\> 92% temperature:37 ℃ By condition, gradually tap Flow 5 L/m', 'interventionNames': ['Device: Heated Humidified High-Flow Nasal Cannula']}], 'interventions': [{'name': 'Heated Humidified High-Flow Nasal Cannula', 'type': 'DEVICE', 'otherNames': ['Noninvasive Ventilation'], 'description': 'Participants using of invasive ventilator more than 14 days, maybe considered transferred to the Respiratory Care Center(RCC), participants enrolled to this study and also written informed consent from participants or their family; After extubation, the difficult weaning patients were allocated to two treatment groups, and randomly assigned to Heated Humidified High-Flow Nasal Cannula or Noninvasive Ventilation devices.', 'armGroupLabels': ['Heated Humidified High-Flow Nasal Cannula group', 'Noninvasive Ventilation group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Chen-Chun Lin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shin Kong Wu Ho-Su Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shin Kong Wu Ho-Su Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fu Jen Catholic University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}