Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-02 @ 9:35 PM
Study NCT ID:
NCT02267759
Status:
COMPLETED
Last Update Posted:
2015-06-19
First Post:
2014-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
McGrath Videolaryngoscopy for Nasotracheal Intubation
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']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-17', 'studyFirstSubmitDate': '2014-10-14', 'studyFirstSubmitQcDate': '2014-10-14', 'lastUpdatePostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to intubation', 'timeFrame': '4 min after anesthetic induction', 'description': 'time the nasotracheal tube was inserted into nares until endtidal CO2 was detected'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Nasotracheal Intubation']}, 'descriptionModule': {'briefSummary': 'McGrath videolaryngoscopy avoids the use of Magill forceps for nasotracheal intubation, thereby reducing intubation time and complications, especially in patients with a difficult airway. This study was performed to investigate whether McGrath videolaryngoscopy is superior to Macintosh laryngoscopy for routine nasotracheal intubation in expected normal airways, as judged by the time to intubation and ease of intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients for dental or maxillofacial surgery requiring nasotracheal intubation\n\nExclusion Criteria:\n\n* known difficult airway\n* required rapid sequence induction\n* history of bleeding\n* cervical spine injury'}, 'identificationModule': {'nctId': 'NCT02267759', 'briefTitle': 'McGrath Videolaryngoscopy for Nasotracheal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'A Comparison of McGrath Videolaryngoscopy and Macintosh Laryngoscopy for Routine Nasotracheal Intubation', 'orgStudyIdInfo': {'id': 'AJIRB-DEV-DE1-14-312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'McGrath', 'description': 'Nasotracheal intubation was performed with McGrath videolaryngoscopy', 'interventionNames': ['Device: Macintosh laryngoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Macintosh', 'description': 'Nasotracheal intubation was performed with Macintosh direct laryngoscopy', 'interventionNames': ['Device: McGrath videolaryngoscopy']}], 'interventions': [{'name': 'McGrath videolaryngoscopy', 'type': 'DEVICE', 'description': 'After the softened nasotracheal tube was inserted into the nares until its tip passed through the posterior nares, McGrath videolaryngoscope was introduced into the mouth and the nasotracheal tube was advanced.', 'armGroupLabels': ['Macintosh']}, {'name': 'Macintosh laryngoscopy', 'type': 'DEVICE', 'description': 'After the softened nasotracheal tube was inserted into the nares until its tip passed through the posterior nares, Macintosh laryngoscope was introduced into the mouth and the nasotracheal tube was advanced.', 'armGroupLabels': ['McGrath']}]}, 'contactsLocationsModule': {'locations': [{'zip': '443-721', 'city': 'Suwon', 'state': 'Gyeongki-do', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Jong Yeop Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jong Yeop Kim', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}