Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT01818102
Status:
COMPLETED
Last Update Posted:
2015-05-22
First Post:
2013-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CT Window Setting to Select Double-lumen Tube Size
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-20', 'studyFirstSubmitDate': '2013-03-18', 'studyFirstSubmitQcDate': '2013-03-21', 'lastUpdatePostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Air-leak at deflation of bronchial cuff', 'timeFrame': 'An expected average of 10 min after double lumen tube intubation'}, {'measure': 'Air-tight seal below resting volume of bronchial cuff', 'timeFrame': 'An expected average of 10 min after double lumen tube intubation'}]}, 'conditionsModule': {'conditions': ['Bronchial Cuff Volume at Air-tight Seal', 'Intracuff Cuff Pressure at Air-tighe Seal']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the appropriate window setting of chest computed tomography to select a correct size of double-lumen endobronchial tube.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes\n\nExclusion Criteria:\n\n* Abnoraml anatomy of tracheobronchail tree\n* Intraluminal lesion in the left mainstem bronchus\n* Anticipated difficult intubation'}, 'identificationModule': {'nctId': 'NCT01818102', 'briefTitle': 'CT Window Setting to Select Double-lumen Tube Size', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'JHBahk_DLT_CT window'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Width 1000 HU/Level -450 HU', 'interventionNames': ['Device: Width 1000 HU/Level -450 HU']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Width 400 HU/Level 25 HU', 'interventionNames': ['Device: Width 400 HU/Level 25 HU']}], 'interventions': [{'name': 'Width 1000 HU/Level -450 HU', 'type': 'DEVICE', 'description': 'Double-lumen tube size is selected according to the internal diameter of the left mainstem bronchus measured in the chest computed tomography with width 1000 HU and level -450 HU.', 'armGroupLabels': ['Width 1000 HU/Level -450 HU']}, {'name': 'Width 400 HU/Level 25 HU', 'type': 'DEVICE', 'description': 'Double-lumen tube size is selected according to the internal diameter of the left mainstem bronchus measured in the chest computed tomography with width 400 HU and level 25 HU.', 'armGroupLabels': ['Width 400 HU/Level 25 HU']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jae-Hyon Bahk, MD, PhD', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}