Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-01-01 @ 7:59 AM
Study NCT ID:
NCT04127903
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2019-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Length of the Right Main Stem Bronchus as a Guide to Right-sided Double-lumen Tube Use
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-14', 'studyFirstSubmitDate': '2019-10-13', 'studyFirstSubmitQcDate': '2019-10-13', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of Uniblocker displacement', 'timeFrame': '1 year'}, {'measure': 'The number of adjust the right-sided double-lumen tube to optimum location', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Therapeutic Procedural Complication']}, 'referencesModule': {'references': [{'pmid': '35982403', 'type': 'DERIVED', 'citation': 'Liu Z, Liu M, Zhao L, Qi X, Yu Y, Liang S, Yang X, Ma Z. Comparison of the accuracy of three methods measured the length of the right main stem bronchus by chest computed tomography as a guide to the use of right sided double-lumen tube. BMC Anesthesiol. 2022 Aug 18;22(1):264. doi: 10.1186/s12871-022-01744-z.'}]}, 'descriptionModule': {'briefSummary': 'The Length of the Right Main Stem Bronchus Measured by Computerised Tomography as a Guide to Right-sided Double-lumen Tube Use', 'detailedDescription': 'The double lumen tube (DLT) is the most popular way to isolate the lungs for thoracic surgery. The variable anatomy of the length of the right main stem bronchus seems to be the main reason clinicians are unwilling to use the right-sided DLT (R-DLT). The factors that could compromise the adequate ventilation of the right lung are mostly the variable length of the Right Main Stem Bronchus and the misalignment of the lateral orifice of the right-sided DLT in regard to the right upper lobe bronchus (RULB). The objectives of this study were to validate an alternative method to estimate the length of the Right Main Stem Bronchus by Computerised Tomography as a Guide to Right-sided Double-lumen Tube Use'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients undergoing thoracic surgery\n\nExclusion Criteria:\n\n1. Age\\>70 or \\<18 years\n2. ASA classifications \\>III\n3. BMI \\>35kg/m2\n4. Modified Mallampati classification ≥III\n5. Thoracic surgery within the last one month\n6. Severe cardiopulmonary disease'}, 'identificationModule': {'nctId': 'NCT04127903', 'briefTitle': 'The Length of the Right Main Stem Bronchus as a Guide to Right-sided Double-lumen Tube Use', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The First Hospital of Qinhuangdao'}, 'officialTitle': 'The First Hospital of Qinhuangdao, Qinhuangdao, Hebei, China.', 'orgStudyIdInfo': {'id': '2019A123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the Length of Right Main Stem Bronchus >=15mm', 'interventionNames': ['Other: the Length of Right Main Stem Bronchus']}, {'type': 'EXPERIMENTAL', 'label': 'the Length of Right Main Stem Bronchus <15mm', 'interventionNames': ['Other: the Length of Right Main Stem Bronchus']}], 'interventions': [{'name': 'the Length of Right Main Stem Bronchus', 'type': 'OTHER', 'description': 'The distance between the carina and the proximal margin of the right upper lobe orifice on the coronal plane measured by computerised tomography', 'armGroupLabels': ['the Length of Right Main Stem Bronchus <15mm', 'the Length of Right Main Stem Bronchus >=15mm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '066000', 'city': 'Qinhuangdao', 'state': 'Hebei', 'country': 'China', 'facility': 'The first hospital of Qinhuangdao', 'geoPoint': {'lat': 39.94104, 'lon': 119.58936}}], 'overallOfficials': [{'name': 'Ximing Qi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Hospital of Qinhuangdao'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Qinhuangdao', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}