Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-03 @ 12:04 AM
Study NCT ID:
NCT02316769
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2014-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison Study of the McGrath MAC Video Laryngoscope With the King Vision
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bret.d.alvis@vanderbilt.edu', 'phone': '6159365836', 'title': 'Bret Alvis', 'organization': 'Vanderbilt University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'King Vision Video Laryngoscope', 'description': 'Patient intubated with the King Vision Video Laryngoscope\n\nIntubation with the King Vision video laryngoscope', 'otherNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'McGrath MAC Video Laryngoscope', 'description': 'Patient intubated with the McGrath MAC Video Laryngoscope\n\nIntubation with the McGrath MAC video laryngoscope', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intubation Success on First Attempt as Measured by End Tidal Carbon Dioxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'King Vision Video Laryngoscope', 'description': 'Patient intubated with the King Vision Video Laryngoscope\n\nIntubation with the King Vision video laryngoscope'}, {'id': 'OG001', 'title': 'McGrath MAC Video Laryngoscope', 'description': 'Patient intubated with the McGrath MAC Video Laryngoscope\n\nIntubation with the McGrath MAC video laryngoscope'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'participants were followed up to the point the video device is removed from the airway, classified as under 90 seconds.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'King Vision Video Laryngoscope', 'description': 'Patient intubated with the King Vision Video Laryngoscope\n\nIntubation with the King Vision video laryngoscope'}, {'id': 'OG001', 'title': 'McGrath MAC Video Laryngoscope', 'description': 'Patient intubated with the McGrath MAC Video Laryngoscope\n\nIntubation with the McGrath MAC video laryngoscope'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Intubation time was initiated at the time of entry of the study device beyond the teeth/gum line and the intubation time was stopped when the study device was removed beyond the same point.', 'description': 'Number of patients intubated in less than 90 seconds', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'King Vision Video Laryngoscope', 'description': 'Patient intubated with the King Vision Video Laryngoscope\n\nIntubation with the King Vision video laryngoscope'}, {'id': 'FG001', 'title': 'McGrath MAC Video Laryngoscope', 'description': 'Patient intubated with the McGrath MAC Video Laryngoscope\n\nIntubation with the McGrath MAC video laryngoscope'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'In the King Vision arm one patient was removed from the surgery secondary to a planned procedure change and another was removed from the study because they declined to participate after already signing consent for this study. This explains the 31 patient enrollment in the King Vision arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'King Vision Video Laryngoscope', 'description': 'Patient intubated with the King Vision Video Laryngoscope\n\nIntubation with the King Vision video laryngoscope'}, {'id': 'BG001', 'title': 'McGrath MAC Video Laryngoscope', 'description': 'Patient intubated with the McGrath MAC Video Laryngoscope\n\nIntubation with the McGrath MAC video laryngoscope'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '15', 'groupId': 'BG000'}, {'value': '52', 'spread': '21', 'groupId': 'BG001'}, {'value': '52', 'spread': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2014-09-05', 'resultsFirstSubmitDate': '2015-07-24', 'studyFirstSubmitQcDate': '2014-12-12', 'lastUpdatePostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-14', 'studyFirstPostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation Success on First Attempt as Measured by End Tidal Carbon Dioxide', 'timeFrame': 'participants were followed up to the point the video device is removed from the airway, classified as under 90 seconds.'}], 'secondaryOutcomes': [{'measure': 'Time to Intubation', 'timeFrame': 'Intubation time was initiated at the time of entry of the study device beyond the teeth/gum line and the intubation time was stopped when the study device was removed beyond the same point.', 'description': 'Number of patients intubated in less than 90 seconds'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Video Laryngoscopic Device Usage in Novice Users']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators compare the effectiveness of two relatively new video laryngoscopes, McGrath MAC (Covidien, Dublin Ireland) and the King Vision (King Systems, Noblesville, IN), by practitioners experienced in airway management but with limited exposure to these two devices. Our hypothesis was that, the McGrath MAC device would require fewer intubation attempts and shorter intubation times than the King Vision when performed by novice users.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All interested airway providers (Residents, Attendings, Certified Nurse Anesthetist and\n* Student Registered Nurse Anesthetist) will be eligible to be included. -\n\nExclusion Criteria:\n\n* All patients with difficult airways as determined by history or physical exam (limited oral opening, limited cervical extension, receding chin, Mallampati class III or IV).'}, 'identificationModule': {'nctId': 'NCT02316769', 'briefTitle': 'Comparison Study of the McGrath MAC Video Laryngoscope With the King Vision', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Randomized Controlled Trial Comparing the McGrath MAC Video Laryngoscope With the King Vision Video Laryngoscope in Adult Patients.', 'orgStudyIdInfo': {'id': '120884'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'King Vision Video Laryngoscope', 'description': 'Patient intubated with the King Vision Video Laryngoscope', 'interventionNames': ['Procedure: King Vision video laryngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'McGrath MAC Video Laryngoscope', 'description': 'Patient intubated with the McGrath MAC Video Laryngoscope', 'interventionNames': ['Procedure: McGrath MAC video laryngoscope']}], 'interventions': [{'name': 'King Vision video laryngoscope', 'type': 'PROCEDURE', 'description': 'Patient intubated with the King Vision Video Laryngoscope', 'armGroupLabels': ['King Vision Video Laryngoscope']}, {'name': 'McGrath MAC video laryngoscope', 'type': 'PROCEDURE', 'description': 'Intubation with the McGrath MAC video laryngoscope', 'armGroupLabels': ['McGrath MAC Video Laryngoscope']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bret Alvis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Bret Alvis', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}