Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-08 @ 5:52 AM
Study NCT ID:
NCT03677505
Status:
COMPLETED
Last Update Posted:
2020-03-11
First Post:
2018-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
KoMAC Videolaryngoscope for Double-lumen 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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2018-09-18', 'studyFirstSubmitQcDate': '2018-09-18', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation time', 'timeFrame': 'from 2 min after rocuronium injection to completion of intubation (time interval is about 120 seconds)', 'description': 'Time interval between laryngoscope passing the teeth to the confirming of end tidal CO2'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['double lumen intubation', 'videolaryngoscope'], 'conditions': ['Intubation']}, 'descriptionModule': {'briefSummary': 'KoMAC videolaryngoscope is a portable intubating device with an angulated single-use blade of adjustable size and a liquid crystal display monitor mounted on top of the handle, which is similar in shape to the McGrath videolaryngoscope. The purpose of this study was to evaluate the efficacy of the KoMAC videolaryngoscope for double-lumen intubation regarding intubation time, laryngeal view and ease of intubation, compared to Macintosh laryngoscope.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for thoracic surgery requiring one lung ventilation\n\nExclusion Criteria:\n\n* predicted difficult airway\n* rapid sequence intubation\n* cervical injury'}, 'identificationModule': {'nctId': 'NCT03677505', 'briefTitle': 'KoMAC Videolaryngoscope for Double-lumen Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Comparison of the KoMAC Videolaryngoscope With the Macintosh Laryngoscope for Double-lumen Intubation', 'orgStudyIdInfo': {'id': 'AJIRB-MED-OBS-18-286'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KoMAC group', 'description': 'Orotracheal intubation with KoMAC videolaryngoscope', 'interventionNames': ['Device: KoMAC videolaryngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Macintosh group', 'description': 'Orotracheal intubation with Macintosh laryngoscope', 'interventionNames': ['Device: Macintosh Laryngoscope']}], 'interventions': [{'name': 'KoMAC videolaryngoscope', 'type': 'DEVICE', 'description': 'Double lumen endotracheal intubation was performed with the KoMAC videolaryngoscope', 'armGroupLabels': ['KoMAC group']}, {'name': 'Macintosh Laryngoscope', 'type': 'DEVICE', 'description': 'Double lumen endotracheal intubation was performed with the Macintosh Laryngoscope', 'armGroupLabels': ['Macintosh group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Jong Yeop Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jong Yeop Kim', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}