Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-02-06 @ 2:56 AM
Study NCT ID:
NCT03392766
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2018-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube in Patients With Semi-regid Neck Collar.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013896', 'term': 'Thoracic Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-22', 'studyFirstSubmitDate': '2018-01-02', 'studyFirstSubmitQcDate': '2018-01-04', 'lastUpdatePostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intubation time', 'timeFrame': 'through study completion, an average of 4 hour', 'description': 'the time from the passage of the fibreoptic bronchoscope beyond the teeth, to tracheal tube positioning above the carina.'}], 'secondaryOutcomes': [{'measure': 'insertion time', 'timeFrame': 'through study completion, an average of 4 hour', 'description': 'the time from the passage of the fibreoptic bronchoscope beyond the teeth, to fibreoptic bronchoscope positioning above the carina'}, {'measure': 'railroading time', 'timeFrame': 'through study completion, an average of 4 hour', 'description': 'the time from fibreoptic bronchoscope positioning above the carina to tracheal tube positioning above the carina.'}, {'measure': 'grade of ease of insertion over fibreoptic bronchoscope', 'timeFrame': 'through study completion, an average of 4 hour', 'description': '1, no difficulty passing the tube; 2, obstruction while passing the tube, relieved by withdrawal and a 90° counter-clockwise rotation; 3, obstruction necessitating more than one manipulation or external laryngeal manipulation; 4, direct laryngoscopy was required.'}, {'measure': 'trauma around the glottis', 'timeFrame': 'through study completion, an average of 4 hour', 'description': 'fibreoptic observation of the glottic bleeding.'}, {'measure': 'complication at the post-anesthesia care unit', 'timeFrame': 'through study completion, an average of 4 hour', 'description': 'hoarseness, sore throat, swallowing difficulty'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fibreoptic intubation', 'double lumen tube', 'difficult intubation'], 'conditions': ['Intubation;Difficult', 'Thoracic Diseases']}, 'referencesModule': {'references': [{'pmid': '37225777', 'type': 'DERIVED', 'citation': 'Kang S, Chae YJ, Kim DH, Bae SY, Yoo JY. Comparison of silicone double-lumen tube and polyvinyl chloride single-lumen tube in fiberoptic tracheal intubation on a difficult airway model: a randomized controlled non-inferiority trial. Sci Rep. 2023 May 24;13(1):8397. doi: 10.1038/s41598-023-35635-1.'}]}, 'descriptionModule': {'briefSummary': 'Many intrathoracic procedures demand optimal collapse of the operative lung to facilitate surgical exposure. Single-lung ventilation can be achieved using a double-lumen tube (DLT), a Univent tube, or an independent bronchial blocker. Insertion of a DLT using a direct laryngoscope can be more difficult than that of single-lumen tube (SLT), especially in patients for whom airway difficulty is anticipated. The safest of the proposed methods involves the placement of an SLT with the aid of an fibreoptic bronchoscope (FOB), following which the SLT is replaced with a DLT using an airway exchange technique in these patients. HumanBroncho® (Insung Medical, Seoul, Korea) is a new silicone DLT with a soft, flexible, non-bevelled, wire-reinforced tip. The oval shape, obtuse angle, and short lateral internal diameter of the bronchial lumen and its flexibility may allow for advancement to the trachea over the FOB with as much as ease as a standard SLT. In the present study, the investigators aimed to test the hypothesis that the HumanBroncho® DLT would be non-inferior to a standard SLT with regard to intubation time over an FOB in patients with semi-rigid neck collar simulating difficult airway.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing thoracic surgery requiring one lung ventilation. American Society of Anesthesiologist, Physical Status 1,2\n\nExclusion Criteria:\n\n* abnormality of upper airway gastroesophageal disease risk of aspiration BMI \\> 35'}, 'identificationModule': {'nctId': 'NCT03392766', 'briefTitle': 'Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube in Patients With Semi-regid Neck Collar.', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Comparison of Fiberoptic Intubation Between Double Lumen Tube and Single Lumen Tube in Patients With Semi-rigid Neck Collar Immobilization of the Cervical Spine.', 'orgStudyIdInfo': {'id': 'AJIRB-DEV-OBS-17-247'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single lumen tube and bronchial blocker', 'description': 'neck collar apply. fibreoptic intubation with single lumen tube and brochial blocker', 'interventionNames': ['Device: single lumen tube and bronchial blocker']}, {'type': 'EXPERIMENTAL', 'label': 'Double lumen tube', 'description': 'neck collar apply. fibreoptic intubation with double lumen tube', 'interventionNames': ['Device: double lumen tube']}], 'interventions': [{'name': 'single lumen tube and bronchial blocker', 'type': 'DEVICE', 'description': 'neck collar apply. fibreoptic intubation with single lumen tube and bronchial blocker.', 'armGroupLabels': ['Single lumen tube and bronchial blocker']}, {'name': 'double lumen tube', 'type': 'DEVICE', 'description': 'neck collar apply. fibreoptic intubation with double lumen tube.', 'armGroupLabels': ['Double lumen tube']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou universiry hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Dae Hee Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou unversity hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'DAE HEE KIM', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}