Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT02133235
Status:
COMPLETED
Last Update Posted:
2015-11-23
First Post:
2014-04-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Need of Fiberoptic Bronchoscopy for Placing an Endobronchial Blocker
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D013896', 'term': 'Thoracic Diseases'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003226', 'term': 'Congresses as Topic'}, {'id': 'D001307', 'term': 'Auditory Perception'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D000084323', 'term': 'Vestibulocochlear Physiological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chengyj@ntu.edu.tw', 'phone': '886-2-23123456', 'title': 'YJ Cheng', 'phoneExt': '62158', 'organization': 'NTUH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 week', 'eventGroups': [{'id': 'EG000', 'title': 'Conventional Fiberoptic Brochoscopy Group', 'description': 'patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition', 'otherNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Auscultation Group', 'description': 'patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition', 'otherNumAtRisk': 57, 'otherNumAffected': 3, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Failure for optimal lung isolation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Surgical Grading for Lung Isolation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Left-sided VATS, Auscultation Group', 'description': 'patients receiving left-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by auscultation only'}, {'id': 'OG001', 'title': 'Left-sided VATS, Conventional Fiberoptic Brochoscopy Group', 'description': 'patients receiving left-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by conventional fiberoptic brochoscopy group'}, {'id': 'OG002', 'title': 'Right-sided VATS, Auscultation Group', 'description': 'patients receiving right-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by auscultation only'}, {'id': 'OG003', 'title': 'Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group', 'description': 'patients receiving right-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by conventional fiberoptic brochoscopy group'}], 'classes': [{'title': 'A: Optimal', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'B: Lung distension', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'C: Poor endobronchial blocker placement', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10-15 minutes', 'description': 'A: Optimal; B: Lung distension; C: Poor endobronchial blocker placement', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time Required for Proper Placement of the Endobronchial Blocker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Left-sided VATS, Auscultation Group', 'description': 'patients receiving left-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition'}, {'id': 'OG001', 'title': 'Left-sided VATS, Conventional Fiberoptic Brochoscopy Group', 'description': 'patients receiving left-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition'}, {'id': 'OG002', 'title': 'Right-sided VATS, Auscultation Group', 'description': 'patients receiving right-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition'}, {'id': 'OG003', 'title': 'Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group', 'description': 'patients receiving right-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition'}], 'classes': [{'categories': [{'measurements': [{'value': '138.5', 'spread': '25.5', 'groupId': 'OG000'}, {'value': '130', 'spread': '20', 'groupId': 'OG001'}, {'value': '89.6', 'spread': '9.3', 'groupId': 'OG002'}, {'value': '141.1', 'spread': '16.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10-15 minutes', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Conventional Fiberoptic Brochoscopy Group', 'description': 'patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition'}, {'id': 'FG001', 'title': 'Auscultation Group', 'description': 'patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Auscultation Group', 'description': 'patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition'}, {'id': 'BG001', 'title': 'Conventional Fiberoptic Brochoscopy Group', 'description': 'patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '79'}, {'value': '58', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '79'}, {'value': '58', 'groupId': 'BG002', 'lowerLimit': '30', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-20', 'studyFirstSubmitDate': '2014-04-28', 'resultsFirstSubmitDate': '2015-06-30', 'studyFirstSubmitQcDate': '2014-05-06', 'lastUpdatePostDateStruct': {'date': '2015-11-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-20', 'studyFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Grading for Lung Isolation', 'timeFrame': '10-15 minutes', 'description': 'A: Optimal; B: Lung distension; C: Poor endobronchial blocker placement'}, {'measure': 'Time Required for Proper Placement of the Endobronchial Blocker', 'timeFrame': '10-15 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endobronchial blocker', 'lung separation', 'vedio-assisted thoracic operation'], 'conditions': ['Neoplasms, Pulmonary', 'Thoracic Diseases']}, 'referencesModule': {'references': [{'pmid': '28950380', 'type': 'DERIVED', 'citation': 'Wang ML, Wang YP, Hung MH, Hsu HH, Chen JS, Yang FS, Cheng YJ. Is fibre-optic bronchoscopy necessary to confirm the position of rigid-angled endobronchial blockers before thoracic surgery? A randomized controlled trial. Eur J Cardiothorac Surg. 2018 Jan 1;53(1):241-246. doi: 10.1093/ejcts/ezx260.'}]}, 'descriptionModule': {'briefSummary': 'The need of fiberoptic bronchoscopy for placing an endobronchial blocker. Endobronchial blockers (EBB) have been presented effective and safe alternative for lung separation in vedio-assisted thoracoscopic (VATS) operations. In this study, the investigators will randomize the patients receiving VATS operation with EBB into two groups: one group will receive the conventional bronchoscopic guided EBBs placement, the other group receive two step procedure without confirmation by fiberoptic bronchoscopy.', 'detailedDescription': 'The need of fiberoptic bronchoscopy for placing an endobronchial blocker. Endobronchial blockers (EBB) have been presented effective and safe alternative for lung separation in vedio-assisted thoracoscopic (VATS) operations. However, there were previous reports showed that it takes longer time to position the EBB versus the double lumen tubes. Placing EBBs need three-step procedure (one is placing an endotracheal tube, the second is inserting the EBB, the third is confirmation of the position by fiberoptic bronchoscopy). In this study, the investigators will randomize the patients receiving VATS operation with EBB into two groups: one group will receive the conventional 3-step procedure, the other group receive two step procedure without confirmation by fiberoptic bronchoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nLung separation by endobronchial blockers\n\nExclusion criteria:\n\nLung separation by conventional double lumen tube Lung separation with endobronchial blockers through'}, 'identificationModule': {'nctId': 'NCT02133235', 'briefTitle': 'The Need of Fiberoptic Bronchoscopy for Placing an Endobronchial Blocker', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Need and the Effectiveness of Fiberoptic Bronchoscopy for Better Lung Collapse in Vedio-assisted Thoracic Operations Using Endobronchial Blockers', 'orgStudyIdInfo': {'id': '201212175RINC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional', 'description': 'insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition', 'interventionNames': ['Procedure: conventional']}, {'type': 'EXPERIMENTAL', 'label': 'auscultation', 'description': 'insertion endobronchial blocker by auscultation without conventional bronchoscopic reposition', 'interventionNames': ['Procedure: auscultation']}], 'interventions': [{'name': 'conventional', 'type': 'PROCEDURE', 'description': 'insertion endobronchial blocker with the guidance of fiberoptic bronchoscopy', 'armGroupLabels': ['conventional']}, {'name': 'auscultation', 'type': 'PROCEDURE', 'description': 'insertion endobronchial blocker by auscultation, without the guidance of fiberoptic bronchoscopy', 'armGroupLabels': ['auscultation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ya-Jung Cheng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}