Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-02-25 @ 4:17 AM
Study NCT ID:
NCT02647606
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2015-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Videolaryngoscopes With Manual In-line Stabilization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-04', 'studyFirstSubmitDate': '2015-12-28', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time for intubation', 'timeFrame': 'from holding the laryngoscope until the 1st ventilation after intubation, within 90 seconds'}, {'measure': 'Cormack Lehane Laryngeal view', 'timeFrame': 'when laryngoscope is appropriately placed during intubation, approximately 2 seconds'}, {'measure': 'POGP score', 'timeFrame': 'when laryngoscope is appropriately placed during intubation, approximately 2 seconds', 'description': 'Percentage of glottic opening(POGO)'}], 'secondaryOutcomes': [{'measure': 'external laryngeal manipulation', 'timeFrame': 'when laryngoscope is appropriately placed during intubation, approximately 2 seconds', 'description': 'When the laryngeal view is insufficient during laryngoscope, another physician can manipulate the larynx externally to improve the laryngeal view. The necessity of external laryngeal manipulation will be recorded.'}, {'measure': 'magill forceps', 'timeFrame': 'when laryngoscope is appropriately placed during intubation, approximately 5 seconds', 'description': 'when the nasotracheal tube can not introduced to vocal cord manually, magill forceps can hold the tube to advance the tube through vocal cord. The necessity of magill forceps during intubation will be recorded'}, {'measure': 'IDS (intubation difficulty scale)', 'timeFrame': 'during intubation, approximately 90 seconds', 'description': 'IDS score is the sum of the following seven variables:\n\nN1: the number of intubation attempts\\>1 N2: the number of operators. 1 N3: the number of alternative intubation techniques used N4: glottic exposure (Cormack Lehane grade minus 1) N5: Lifting force required during laryngoscopy (0=normal; 1=increased) N6: necessity for external laryngeal pressure (0=not applied; 1=applied) N7: position of the vocal cords at intubation (0=abduction/ not visualized; 1=adduction)'}, {'measure': 'numeric rating scale for intubation', 'timeFrame': 'during intubation, approximately 90 seconds', 'description': '0-10 (0; no difficulty, 10: hardest)'}, {'measure': 'grade of bleeding', 'timeFrame': '10 seconds after completion of intubation', 'description': 'After confirmation of successful intubation, Yankauer suction was introduced to access the intraoral bleeding during intubation.\n\nGrade is 4 points scale (none/trace/moderate/severe).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Oral Surgery', 'Maxillofacial Surgery']}, 'referencesModule': {'references': [{'pmid': '31144258', 'type': 'DERIVED', 'citation': 'Roh GU, Kwak HJ, Lee KC, Lee SY, Kim JY. Randomized comparison of McGrath MAC videolaryngoscope, Pentax Airway Scope, and Macintosh direct laryngoscope for nasotracheal intubation in patients with manual in-line stabilization. Can J Anaesth. 2019 Oct;66(10):1213-1220. doi: 10.1007/s12630-019-01409-5. Epub 2019 May 29.'}]}, 'descriptionModule': {'briefSummary': 'Videolaryngoscope is useful to improve the laryngeal view, especially during difficult intubation. There are several kinds of videolaryngoscopes and it is applicable during nasotracheal intubation. In this study, the investigators will compare the McGrath videolaryngoscope and Pentax-AWS with Macintosh laryngoscope for nasotracheal intubation in patients with manual in-line stabilization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* oral or maxillofacial surgery\n* ASA class I, II\n\nExclusion Criteria:\n\n* anticipated difficult intubation\n* necessity for rapid sequence induction\n* cervical spine injury\n* bleeding tendency'}, 'identificationModule': {'nctId': 'NCT02647606', 'briefTitle': 'Comparison of the Videolaryngoscopes With Manual In-line Stabilization', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Comparison of the McGrath Videolaryngoscope and the Pentax-AWS With the Macintosh Laryngoscope for Nasotracheal Intubation in Patients With Manual In-line Stabilization', 'orgStudyIdInfo': {'id': 'AJIRB-MED-DE1-15-334'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'McGrath Group', 'description': 'MgGrath videolaryngoscope will be used for nasotracheal intubation with MILS', 'interventionNames': ['Procedure: MILS', 'Device: McGrath videolaryngoscope']}, {'type': 'EXPERIMENTAL', 'label': 'Pentax-AWS Group', 'description': 'Pentax-AWS videolaryngoscope will be used for nasotracheal intubation with MILS', 'interventionNames': ['Procedure: MILS', 'Device: Pentax AWS videolaryngoscope']}, {'type': 'EXPERIMENTAL', 'label': 'Macintosh Laryngoscope Group', 'description': 'Macintosh Laryngoscope will be used for nasotracheal intubation with MILS', 'interventionNames': ['Procedure: MILS', 'Device: Macintosh laryngoscope']}], 'interventions': [{'name': 'MILS', 'type': 'PROCEDURE', 'description': 'MILS(Manual in-line stabilization) will be applied during intubation. With MILS, different kinds of laryngoscope will be evaluated in a simulated difficult airway.', 'armGroupLabels': ['Macintosh Laryngoscope Group', 'McGrath Group', 'Pentax-AWS Group']}, {'name': 'McGrath videolaryngoscope', 'type': 'DEVICE', 'description': 'McGrath videolaryngoscope will be used for intubation', 'armGroupLabels': ['McGrath Group']}, {'name': 'Pentax AWS videolaryngoscope', 'type': 'DEVICE', 'description': 'Pentax AWS videolaryngoscope will be used for intubation', 'armGroupLabels': ['Pentax-AWS Group']}, {'name': 'Macintosh laryngoscope', 'type': 'DEVICE', 'description': 'Macintosh laryngoscope will be used for intubation', 'armGroupLabels': ['Macintosh Laryngoscope Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Go Un Roh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Go Un Roh', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}