Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-01 @ 9:37 AM
Study NCT ID:
NCT01371032
Status:
COMPLETED
Last Update Posted:
2021-09-21
First Post:
2011-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study: Study to Compare Video Miller Device to Direct Laryngoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Roya.Yumul@cshs.org', 'phone': '310-423-1682', 'title': 'Dr. Roya Yumul, MD, PhD', 'organization': 'Cedars Sinai Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'One day', 'eventGroups': [{'id': 'EG000', 'title': 'Video-Miller Laryngoscope', 'description': 'Video-Miller laryngoscopy group (using the screen of the Video-Miller laryngoscope device for intubation)', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Direct Laryngoscopy', 'description': 'Direct laryngoscopy group (using the video-Miller laryngoscope, without access to the screen).', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Obtain Glottic View', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video-Miller Laryngoscope', 'description': 'using the screen (Video laryngoscopy group)\n\nVideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group)'}, {'id': 'OG001', 'title': 'Direct Laryngoscopy', 'description': 'without use the screen (Direct laryngoscopy group)\n\nDirect Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '5', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '6.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Times following initial insertion of laryngoscope blade to obtain glottic view', 'description': 'Time to obtain glottic view (from initial insertion of laryngoscope blade to obtain glottic view)', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Intubation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video-Miller Laryngoscope', 'description': 'Video-Miller laryngoscopy group (using the screen of the Video-Miller laryngoscope device for intubation)'}, {'id': 'OG001', 'title': 'Direct Laryngoscopy', 'description': 'Direct laryngoscopy group (using the video-Miller laryngoscope, without access to the screen).'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'spread': '11', 'groupId': 'OG000'}, {'value': '28', 'spread': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Times from insertion of laryngoscope blade to placement of tracheal tube', 'description': 'Times following initial insertion of laryngoscope blade to placement of tracheal tube', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video-Miller Laryngoscope', 'description': 'Video-Miller laryngoscopy group (using the screen of the Video-Miller laryngoscope device for intubation)'}, {'id': 'OG001', 'title': 'Direct Laryngoscopy', 'description': 'Direct laryngoscopy group (using the video-Miller laryngoscope, without access to the screen).'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'spread': '37', 'groupId': 'OG000'}, {'value': '59', 'spread': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time from initial insertion of laryngoscope blade to confirm w/ CO2 waveform', 'description': 'Time following initial insertion of laryngoscope blade to confirm w/ CO2 waveform', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glottis Visualization Using POGO Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video-Miller Laryngoscope', 'description': 'Video-Miller laryngoscopy group (using the screen of the Video-Miller laryngoscope device for intubation)'}, {'id': 'OG001', 'title': 'Direct Laryngoscopy', 'description': 'Direct laryngoscopy group (using the video-Miller laryngoscope, without access to the screen).'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '93.2', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During intubation procedure, up to 3 minutes', 'description': 'POGO score represents the percentage of glottic opening seen (from 0-100%)', 'unitOfMeasure': 'percentage of glottic opening', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glottis Visualization Using Cormack Lehane', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video-Miller Laryngoscope', 'description': 'Video-Miller laryngoscopy group (using the screen of the Video-Miller laryngoscope device for intubation)'}, {'id': 'OG001', 'title': 'Direct Laryngoscopy', 'description': 'Direct laryngoscopy group (using the video-Miller laryngoscope, without access to the screen).'}], 'classes': [{'title': 'Cormack Lehane score 1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Cormack Lehane score 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During intubation procedure, up to 3 minutes', 'description': 'Glottic visualization comparison between the two devices. Grade Description Approximate frequency Likelihood of difficult intubation\n\n1. Full view of glottis 68-74% \\<1%\n2. a Partial view of glottis 21-24% 4.3-13.4%\n\n2b Only posterior extremity of glottis seen or only arytenoid cartilages 3.3-6.5% 65-67.4% 3 Only epiglottis seen, none of glottis seen 1.2-1.6% 80-87.5% 4 Neither glottis nor epiglottis seen very rare', 'unitOfMeasure': 'Count of Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Intubated With 1 and > 1 Intubation Attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video-Miller Laryngoscope', 'description': 'Video-Miller laryngoscopy group (using the screen of the Video-Miller laryngoscope device for intubation)'}, {'id': 'OG001', 'title': 'Direct Laryngoscopy', 'description': 'Direct laryngoscopy group (using the video-Miller laryngoscope, without access to the screen).'}], 'classes': [{'title': 'Intubation attempt= 1', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Intubation attempts > 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During intubation procedure, up to 3 minutes', 'description': 'Number of Participants intubated after 1 intubation attempt and Number of Participants intubated after \\> 1 intubation attempts', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Video-Miller Laryngoscope', 'description': 'using the screen (Video laryngoscopy group)\n\nVideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group)'}, {'id': 'FG001', 'title': 'Direct Laryngoscopy', 'description': 'without use the screen (Direct laryngoscopy group)\n\nDirect Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Video-Miller Laryngoscope', 'description': 'using the screen (Video laryngoscopy group)\n\nVideoMiller: Video-Miller laryngoscope, using the screen (Video laryngoscopy group)'}, {'id': 'BG001', 'title': 'Direct Laryngoscopy', 'description': 'without use the screen (Direct laryngoscopy group)\n\nDirect Laryngoscopy: Video-Miller laryngoscope, without screen (Direct laryngoscopy group)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '4', 'groupId': 'BG000'}, {'value': '9.6', 'spread': '7', 'groupId': 'BG001'}, {'value': '8', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Caucasian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '3', 'groupId': 'BG000'}, {'value': '10', 'spread': '4', 'groupId': 'BG001'}, {'value': '9', 'spread': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '71', 'spread': '13', 'groupId': 'BG000'}, {'value': '69', 'spread': '13', 'groupId': 'BG001'}, {'value': '70', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Laryngoscope Blade Size', 'classes': [{'title': 'Laryngoscope Blade size 0', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Laryngoscope Blade size 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Laryngoscope blades are used for examination of the interior of the larynx and for placement of an endotracheal tube. The Miller Laryngoscope Blades sizes (The most popular of the straight types) go from 0 to 4. For the pediatric ages used in this studies the sizes used were 0 and 1.', 'unitOfMeasure': 'Count of Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-25', 'studyFirstSubmitDate': '2011-06-09', 'resultsFirstSubmitDate': '2021-07-08', 'studyFirstSubmitQcDate': '2011-06-09', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-25', 'studyFirstPostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Obtain Glottic View', 'timeFrame': 'Times following initial insertion of laryngoscope blade to obtain glottic view', 'description': 'Time to obtain glottic view (from initial insertion of laryngoscope blade to obtain glottic view)'}, {'measure': 'Intubation Time', 'timeFrame': 'Times from insertion of laryngoscope blade to placement of tracheal tube', 'description': 'Times following initial insertion of laryngoscope blade to placement of tracheal tube'}, {'measure': 'Time From Insertion of Laryngoscope Blade to Confirm w/ CO2 Waveform', 'timeFrame': 'Time from initial insertion of laryngoscope blade to confirm w/ CO2 waveform', 'description': 'Time following initial insertion of laryngoscope blade to confirm w/ CO2 waveform'}], 'secondaryOutcomes': [{'measure': 'Glottis Visualization Using POGO Score', 'timeFrame': 'During intubation procedure, up to 3 minutes', 'description': 'POGO score represents the percentage of glottic opening seen (from 0-100%)'}, {'measure': 'Glottis Visualization Using Cormack Lehane', 'timeFrame': 'During intubation procedure, up to 3 minutes', 'description': 'Glottic visualization comparison between the two devices. Grade Description Approximate frequency Likelihood of difficult intubation\n\n1. Full view of glottis 68-74% \\<1%\n2. a Partial view of glottis 21-24% 4.3-13.4%\n\n2b Only posterior extremity of glottis seen or only arytenoid cartilages 3.3-6.5% 65-67.4% 3 Only epiglottis seen, none of glottis seen 1.2-1.6% 80-87.5% 4 Neither glottis nor epiglottis seen very rare'}, {'measure': 'Number of Participants Intubated With 1 and > 1 Intubation Attempts', 'timeFrame': 'During intubation procedure, up to 3 minutes', 'description': 'Number of Participants intubated after 1 intubation attempt and Number of Participants intubated after \\> 1 intubation attempts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgeries Undergoing General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '37171122', 'type': 'DERIVED', 'citation': 'Lingappan K, Neveln N, Arnold JL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2023 May 12;5(5):CD009975. doi: 10.1002/14651858.CD009975.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare:\n\nthe standard pediatric intubation instrument (Miller blade) used as direct laryngoscopy during tracheal intubation to the VideoMiller device (the standard pediatric blade with a camera attached, giving indirect view of the vocal cords in the screen). This intubation device is used to place the tube in the trachea to keep the patient breathing during the surgery procedure.\n\nThe anesthesiologist obtains a better view of the vocal cords looking at the screen provided by the VideoMiller.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 3 years or younger undergoing anesthesia requiring endotracheal intubation.\n2. Obtaining signed the informed consent by their parents or legal guardian.\n3. American Society of Anaesthesiologists (ASA) physical status classification I - II or III\n\nExclusion Criteria:\n\n1. Patients deemed to be at significant airway risk necessitating an awake fiber optic intubation\n2. Patients with facial abnormalities, and/or oral-pharyngeal malformation.\n3. Emergency operation'}, 'identificationModule': {'nctId': 'NCT01371032', 'briefTitle': 'Study: Study to Compare Video Miller Device to Direct Laryngoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'A Randomized, Prospective Study to Compare the Video Miller Device to Direct Laryngoscopy Using a Standard Pediatric Miller Blade for Tracheal Intubation of Children < 3 Years of Age Undergoing General Anesthesia', 'orgStudyIdInfo': {'id': 'Pro00024542'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Video-Miller laryngoscope', 'description': 'using the screen (Video laryngoscopy group)', 'interventionNames': ['Device: VideoMiller']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Direct laryngoscopy', 'description': 'without use the screen (Direct laryngoscopy group)', 'interventionNames': ['Device: Direct Laryngoscopy']}], 'interventions': [{'name': 'VideoMiller', 'type': 'DEVICE', 'description': 'Video-Miller laryngoscope, using the screen (Video laryngoscopy group)', 'armGroupLabels': ['Video-Miller laryngoscope']}, {'name': 'Direct Laryngoscopy', 'type': 'DEVICE', 'description': 'Video-Miller laryngoscope, without screen (Direct laryngoscopy group)', 'armGroupLabels': ['Direct laryngoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Roya Yumul, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}, {'name': 'Ronald H Wender, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Residency program director, Department of anesthesiology', 'investigatorFullName': 'Roya Yumul, M.D.,PhD.', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}