Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-10 @ 3:30 PM
Study NCT ID:
NCT02190032
Status:
COMPLETED
Last Update Posted:
2015-02-24
First Post:
2014-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modified Angled Tube vs. Conventional Angled Tube in Double-lumen Endotracheal Tube Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-22', 'studyFirstSubmitDate': '2014-07-06', 'studyFirstSubmitQcDate': '2014-07-11', 'lastUpdatePostDateStruct': {'date': '2015-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hemodynamic change', 'timeFrame': '1, 3 and 5 min after intubation', 'description': "We will record patient's heart rate, blood pressure and any used cardiovascular drugs at 1, 3 and 5 min after intubation"}, {'measure': 'Intubation difficulty scale score', 'timeFrame': 'At intubation', 'description': 'Intubation difficulty Scale score is a function of seven parameters : number of attempts, number of operators, number of alternative techniques, cormack grade, lifting force needed, laryngeal pressure and vocal cord mobility.\n\n(Ref: Intubation Difficulty Scale, Anesthesiology 1997;87:1290-7)'}], 'primaryOutcomes': [{'measure': 'The time taken to intubate a double-lumen tube', 'timeFrame': 'within 60 sec', 'description': "The time taken to insert the tube begins when the laryngoscope passes the patient's lips and ends when the tube passes the vocal cords"}], 'secondaryOutcomes': [{'measure': 'The number of attempts needed for successful intubation', 'timeFrame': 'Intubation'}, {'measure': 'The time taken for the first attempt of intubation', 'timeFrame': 'within 60 sec'}, {'measure': 'Postoperative sore throat, hoarseness or dysphagia', 'timeFrame': '30 minutes and 24hours after extubation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Intubation, Intratracheal', 'Thoracic Surgical Procedures']}, 'referencesModule': {'references': [{'pmid': '27537372', 'type': 'DERIVED', 'citation': 'Min JJ, Lee JH, Kang SH, Kim E, Lee SM, Cho JH, Kim HK. The Fast and Easy Way for Double-Lumen Tube Intubation: Individual Angle-Modification. PLoS One. 2016 Aug 18;11(8):e0161434. doi: 10.1371/journal.pone.0161434. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'The investigators are trying to compare the individually modified-angled tube and the conventional-angled tube in ease of double lumen endotracheal tube insertion and the incidence of related postoperative complications.', 'detailedDescription': 'Inserting a double lumen endotracheal tube is somewhat more difficult than a single lumen tube intubation because of its larger outer diameter and the more rigid feature. Moreover, the airway axes (oral-,pharyngeal-, and laryngotracheal axis) are not always straight under sniffing condition. Therefore, to make easy to insert a double-lumen tube and reduce the tube-related complications, we are trying to compare the individually angle-modified tube and the manufacturer-provided-angled tube.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects undergoing thoracic surgery under one lung ventilation\n* Subjects older than 20 yrs who can give written informed consent\n\nExclusion Criteria:\n\n* Those who need rapid sequence intubation\n* Those with cervical spinal disease (cervical spinal injury, rheumatoid arthritis with atlantoaxial subluxation)\n* Those with oropharyngeal obstructive disease (including tumor, foreign body)\n* Those who are expected prolonged intubation after surgery\n* Those who are pregnant'}, 'identificationModule': {'nctId': 'NCT02190032', 'briefTitle': 'Modified Angled Tube vs. Conventional Angled Tube in Double-lumen Endotracheal Tube Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Comparison of Individually Modified Angled Tube and Conventional Angled Tube in Double-lumen Endotracheal Tube Intubation: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2014-06-003-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Intubating a manufacturer-provided-angled double-lumen tube (=Conventional-angled group,"MallinckrodtTM endotracheal tube", Covidien)', 'interventionNames': ['Device: Mallinckrodt endobronchial tube with a conventional angle']}, {'type': 'EXPERIMENTAL', 'label': 'Tube angle modification', 'description': "The angle of the double lumen tube(MallinckrodeTM endotracheal tube) is modified individually.At sniffing position, the distal tip of the tube is placed at the patient's cricoid cartilage level and the tube is bent at the intersection point of the two airway axes (oropharyngeal axis and tracheal axis) with an angle between the two axes.", 'interventionNames': ['Device: Mallinckrodt endotracheal tube with a modified angle']}], 'interventions': [{'name': 'Mallinckrodt endotracheal tube with a modified angle', 'type': 'DEVICE', 'otherNames': ['Tube angle modification', '("MallinckrodeTM endotracheal tube", Covidien)'], 'description': "At sniffing position, the distal tip of a double-lumen tube is located at the patient's cricoid cartilage level and then the tube is bent at the intersection point of oral axis and the pharyngolaryngeal axis with an angle between the two axes.", 'armGroupLabels': ['Tube angle modification']}, {'name': 'Mallinckrodt endobronchial tube with a conventional angle', 'type': 'DEVICE', 'otherNames': ['Mallinckrodt endobronchial tube, Covidien, with conventional-angled tube'], 'description': 'Inserting a manufacturer-provided conventional-angled tube', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jong Hwan Lee, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jong Hwan Lee', 'investigatorAffiliation': 'Samsung Medical Center'}}}}