Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT01163656
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2010-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}, {'id': 'D007828', 'term': 'Laryngoscopy'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fiadjoej@email.chop.edu', 'phone': '215-590-3916', 'title': 'John Fiadjoe, MD', 'organization': "The Children's Hospital of Philadelphia"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Direct Laryngoscopy Approach', 'description': 'Subjects were randomly assigned to an arm.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Glidescope Videoscope Approach', 'description': 'Subjects were randomly assigned to an arm.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Tracheal Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Direct Laryngoscopy Approach', 'description': 'Subjects were randomly assigned to an arm.'}, {'id': 'OG001', 'title': 'Glidescope Videoscope Approach', 'description': 'Subjects were randomly assigned to an arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '66.1'}, {'value': '22.6', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '61.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.', 'description': 'The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system.', 'unitOfMeasure': 'seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Direct Laryngoscopy Approach', 'description': 'Subjects were randomly assigned to an arm.'}, {'id': 'FG001', 'title': 'Glidescope Videoscope Approach', 'description': 'Subjects were randomly assigned to an arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Healthy infants under the age of 12 months undergoing elective surgery requiring tracheal intubation were eligible.', 'preAssignmentDetails': 'Any subject was excluded from participation if they were known or suspected to be a difficult intubation or if they required a rapid-sequence intubation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Direct Laryngoscopy Approach', 'description': 'Subjects were randomly assigned to an arm.'}, {'id': 'BG001', 'title': 'Glidescope Videoscope Approach', 'description': 'Subjects were randomly assigned to an arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '0.425', 'spread': '0.275', 'groupId': 'BG000'}, {'value': '0.492', 'spread': '0.283', 'groupId': 'BG001'}, {'value': '0.459', 'spread': '0.279', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-24', 'studyFirstSubmitDate': '2010-07-13', 'resultsFirstSubmitDate': '2012-12-13', 'studyFirstSubmitQcDate': '2010-07-14', 'lastUpdatePostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-13', 'studyFirstPostDateStruct': {'date': '2010-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Tracheal Intubation', 'timeFrame': 'Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.', 'description': 'The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neonate', 'Laryngoscopes'], 'conditions': ['Intubation']}, 'descriptionModule': {'briefSummary': 'The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants.', 'detailedDescription': 'We seek to study the intubation characteristics of a new video laryngoscope, the Glidescope Cobalt in children less than or equal to 1 yr of age. This evaluation would provide insight as to the efficacy of this device in facilitating intubation in infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Scheduled to undergo elective surgery at CHOP\n2. American Society of Anesthesiologists (ASA) Physical Status I or II\n3. Anesthetic plan requiring tracheal intubation with a neuromuscular relaxant\n4. Parental/guardian permission (informed consent). Subjects will be too young to understand the study procedures and therefore assent will not be sought. -\n\nExclusion Criteria:\n\n1. At known or anticipated high risk for aspiration pneumonia\n2. Known or predicted difficult intubation as assessed by the clinical attending anesthesiologist\n3. Emergency surgical procedure\n4. Patients with preoperative airway pathology or stridor -'}, 'identificationModule': {'nctId': 'NCT01163656', 'briefTitle': 'Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'A Prospective Comparison of the Glidescope Cobalt to Standard Direct Laryngoscopy in Infants', 'orgStudyIdInfo': {'id': '10-007533'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Direct Laryngoscopy', 'description': 'Laryngoscopy will be performed with the randomized device, which will be the Miller Laryngoscope.', 'interventionNames': ['Device: Miller Laryngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glidescope Cobalt Video Laryngoscopy', 'description': 'Laryngoscopy will be performed with the randomized device, which will be the Glidescope Cobalt Video Laryngoscope.', 'interventionNames': ['Device: Glidescope Cobalt Video Laryngoscopes']}], 'interventions': [{'name': 'Miller Laryngoscope', 'type': 'DEVICE', 'otherNames': ['tracheal intubation', 'laryngoscopy', 'direct laryngoscopy'], 'description': 'Device is used to facilitate tracheal intubation.', 'armGroupLabels': ['Direct Laryngoscopy']}, {'name': 'Glidescope Cobalt Video Laryngoscopes', 'type': 'DEVICE', 'otherNames': ['Glidescope Cobalt Video Laryngoscopy', 'Video Laryngoscopy'], 'description': 'The laryngoscope design with the integration of video technology into the laryngoscope blade.', 'armGroupLabels': ['Glidescope Cobalt Video Laryngoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "The Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'John Fiadjoe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}