Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-26 @ 7:28 PM
Study NCT ID:
NCT00956592
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2009-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of the Storz CMAC Laryngoscope
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'azizm@ohsu.edu', 'phone': '503-494-5581', 'title': 'Michael Aziz', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CMAC Video Laryngoscope', 'description': 'Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion', 'otherNumAtRisk': 150, 'otherNumAffected': 0, 'seriousNumAtRisk': 150, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Macintosh Blade', 'description': 'Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion', 'otherNumAtRisk': 150, 'otherNumAffected': 0, 'seriousNumAtRisk': 150, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measure of Intubation Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CMAC Video Laryngoscope', 'description': 'Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion'}, {'id': 'OG001', 'title': 'Macintosh Blade', 'description': 'Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion'}], 'classes': [{'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000', 'lowerLimit': '132', 'upperLimit': '144'}, {'value': '124', 'groupId': 'OG001', 'lowerLimit': '117', 'upperLimit': '131'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During each intubation in a 14 month period', 'description': 'Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure', 'unitOfMeasure': 'Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '4 patients of the 300 were excluded because the randomization was not followed due to unavailability of equipment or provider preference to remove patient from study', 'anticipatedPostingDate': '2011-02'}, {'type': 'SECONDARY', 'title': 'Intubation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CMAC Video Laryngoscope', 'description': 'Subjects will have their intubation attempted first with the CMAC video laryngoscope\n\nCMAC video laryngoscope: Intubation utilizing the assistance of video enhancement'}, {'id': 'OG001', 'title': 'Macintosh Blade', 'description': 'Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade\n\nMacintosh laryngoscope: Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '51'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '36'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During laryngoscopy procedure', 'description': 'Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation', 'unitOfMeasure': 'seconds', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'time'}, {'type': 'SECONDARY', 'title': 'Number of Participants Intubated With a Rescue Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CMAC Video Laryngoscope', 'description': 'Subjects will have their intubation attempted first with the CMAC video laryngoscope\n\nCMAC video laryngoscope: Intubation utilizing the assistance of video enhancement'}, {'id': 'OG001', 'title': 'Macintosh Blade', 'description': 'Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade\n\nMacintosh laryngoscope: Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CMAC Video Laryngoscope', 'description': 'Subjects will have their intubation attempted first with the CMAC video laryngoscope\n\nCMAC video laryngoscope: Intubation utilizing the assistance of video enhancement'}, {'id': 'OG001', 'title': 'Macintosh Blade', 'description': 'Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade\n\nMacintosh laryngoscope: Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CMAC Video Laryngoscope', 'description': 'Subjects will have their intubation attempted first with the CMAC video laryngoscope\n\nCMAC video laryngoscope: Intubation utilizing the assistance of video enhancement'}, {'id': 'OG001', 'title': 'Macintosh Blade', 'description': 'Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade\n\nMacintosh laryngoscope: Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade'}], 'classes': [{'categories': [{'title': 'Grade I view achieved', 'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}, {'title': 'Grade 2 view achieved', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Grade 3 view achieved', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'Grade 4 view achieved', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Grade 1= full view of the glottis achieved Grade 2= partial view of the glottis achieved Grade 3= only the epiglottis visualized Grade 4= no laryngeal view achieved', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Particpants Requiring Adjuncts to Assist Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CMAC Video Laryngoscope', 'description': 'Subjects will have their intubation attempted first with the CMAC video laryngoscope\n\nCMAC video laryngoscope: Intubation utilizing the assistance of video enhancement'}, {'id': 'OG001', 'title': 'Macintosh Blade', 'description': 'Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade\n\nMacintosh laryngoscope: Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Use of bougie or external manipulation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CMAC Video Laryngoscope', 'description': 'Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion'}, {'id': 'FG001', 'title': 'Macintosh Blade', 'description': 'Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Patients were recruited at OHSU OR and procedure rooms. 300 patients were enrolled in the study from 10/09-12/10', 'preAssignmentDetails': '4 exclusions were noted for failure to follow the randomization'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CMAC Video Laryngoscope', 'description': 'Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion'}, {'id': 'BG001', 'title': 'Macintosh Blade', 'description': 'Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '55.4', 'spread': '14.5', 'groupId': 'BG001'}, {'value': '54.6', 'spread': '14.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-03', 'studyFirstSubmitDate': '2009-08-10', 'resultsFirstSubmitDate': '2011-01-25', 'studyFirstSubmitQcDate': '2009-08-10', 'lastUpdatePostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-02-14', 'studyFirstPostDateStruct': {'date': '2009-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of Intubation Success', 'timeFrame': 'During each intubation in a 14 month period', 'description': 'Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure'}], 'secondaryOutcomes': [{'measure': 'Intubation Time', 'timeFrame': 'During laryngoscopy procedure', 'description': 'Time was measured as the duration of laryngoscopy defined by blade insertion to tracheal tube cuff inflation'}, {'measure': 'Number of Participants Intubated With a Rescue Device', 'timeFrame': '1 year'}, {'measure': 'Number of Participants With Complications', 'timeFrame': '1 year'}, {'measure': 'Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4.', 'timeFrame': '1 year', 'description': 'Grade 1= full view of the glottis achieved Grade 2= partial view of the glottis achieved Grade 3= only the epiglottis visualized Grade 4= no laryngeal view achieved'}, {'measure': 'Number of Particpants Requiring Adjuncts to Assist Intubation', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Video laryngoscopy', 'Intubation success', 'Difficult airway', 'CMAC laryngoscope'], 'conditions': ['Intubation', 'Airway Management']}, 'referencesModule': {'references': [{'pmid': '19233881', 'type': 'BACKGROUND', 'citation': 'Jungbauer A, Schumann M, Brunkhorst V, Borgers A, Groeben H. Expected difficult tracheal intubation: a prospective comparison of direct laryngoscopy and video laryngoscopy in 200 patients. Br J Anaesth. 2009 Apr;102(4):546-50. doi: 10.1093/bja/aep013. Epub 2009 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the utility of a video assisted device for intubation (placement of a breathing tube) during surgery. This study specifically aims to compare a video assisted intubation with the CMAC laryngoscope to conventional devices in the setting of intubations predicted to be difficult.', 'detailedDescription': 'Patients will be specifically screened for predictors by history and physical exam of potential airway difficulty. The role of video laryngoscopy in airways predicted to be difficult is poorly defined. This study aims to recognize if video laryngoscopy is more useful than conventional laryngoscopy as a first attempt for those with anticipated difficulty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients presenting for elective surgery who are fasted and who have one of the following difficult airway predictors:\n\n * mallampati classification 3\n * mallampati classification 4\n * Reduced mouth opening (\\<3cm)\n * reduced cervical motion\n * history of previous difficult intubation or multiple laryngoscopy attempts\n\nExclusion Criteria:\n\n* Patients less than 18 years old, patients who are not fasted (\\>6 hrs. NPO)\n* Patients who have contraindications to the administration of neuromuscular blocking drugs\n* Patients who have a documented history of intubation on first attempt with C-L grade 1 laryngeal view\n* Patients who are deemed to difficult and dangerous to anesthetize without first securing an airway.'}, 'identificationModule': {'nctId': 'NCT00956592', 'briefTitle': 'Clinical Evaluation of the Storz CMAC Laryngoscope', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'A Randomized Control Trial to Determine First Attempt Intubation Success With the CMAC Laryngoscope vs. Macintosh Blade in Airways Predicted to be Difficult', 'orgStudyIdInfo': {'id': 'IRB00003272'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CMAC Video laryngoscope', 'description': 'Subjects will have their intubation attempted first with the CMAC video laryngoscope', 'interventionNames': ['Device: CMAC video laryngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Macintosh blade', 'description': 'Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade', 'interventionNames': ['Device: Macintosh laryngoscope']}], 'interventions': [{'name': 'CMAC video laryngoscope', 'type': 'DEVICE', 'otherNames': ['CMAC', 'Storz laryngoscope'], 'description': 'Intubation utilizing the assistance of video enhancement', 'armGroupLabels': ['CMAC Video laryngoscope']}, {'name': 'Macintosh laryngoscope', 'type': 'DEVICE', 'otherNames': ['Mac blade'], 'description': 'Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade', 'armGroupLabels': ['Macintosh blade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Michael Aziz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Department of Anesthesiology & Perioperative Medicine', 'investigatorFullName': 'Michael Aziz', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}