Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-02-03 @ 9:15 AM
Study NCT ID:
NCT01080118
Status:
COMPLETED
Last Update Posted:
2013-12-02
First Post:
2010-02-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'g-jr@northwestern.edu', 'phone': '312-472-3573', 'title': 'Dr. Gildasio DeOliveira', 'organization': 'Northwestern University Feinberg School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The intubating laryngeal mask airway the optical laryngoscope device used in this study does not allow for ventilation of the patient if intubation fails. We did not study retention of airway management skills between the groups.'}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Rigid Laryngoscope Group', 'description': 'Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope', 'otherNumAtRisk': 15, 'otherNumAffected': 9, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Video Laryngoscope Group', 'description': 'Medical students or interns attempting intubation with Airtraq video laryngoscope', 'otherNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'mucosal laceration', 'notes': 'Oral mucosa lacerated with introduction of device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'mucosal laceration'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Successful Endotracheal Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rigid Laryngoscope Group', 'description': 'Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope'}, {'id': 'OG001', 'title': 'Video Laryngoscope Group', 'description': 'Medical students or interns attempting intubation with Airtraq video laryngoscope'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '.05', 'ciLowerLimit': '.05', 'ciUpperLimit': '.05', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Equivalence'}], 'paramType': 'NUMBER', 'timeFrame': '120 seconds', 'description': 'A successful placement of the endotracheal tube as defined by the presence of bilateral breath sounds and positive recording of end tidal carbon dioxide.', 'unitOfMeasure': '% successful', 'reportingStatus': 'POSTED', 'populationDescription': 'The sample analysis was all of the medical students or interns who consented to participate in this study. All participants data was used for the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rigid Laryngoscope Group', 'description': 'Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope'}, {'id': 'OG001', 'title': 'Video Laryngoscope Group', 'description': 'Medical students or interns attempting intubation with Airtraq video laryngoscope'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '90'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '44'}]}]}], 'paramType': 'MEAN', 'timeFrame': '120 seconds', 'description': 'Time to intubation is the time interval of blade insertion until the removal of the laryngoscope.', 'unitOfMeasure': 'seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The sample analysis was all of the medical students or interns who consented to participate in this study. All participants data was used for the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rigid Laryngoscope Group', 'description': 'Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope'}, {'id': 'FG001', 'title': 'Video Laryngoscope Group', 'description': 'Medical students or interns attempting intubation with Airtraq video laryngoscope'}, {'id': 'FG002', 'title': 'Rigid Laryngoscope Patients', 'description': 'Patients who were intubated using the rigid laryngoscope by the medical student of intern.'}, {'id': 'FG003', 'title': 'Video Laryngoscope Patients', 'description': 'Patients who were intubated using the video laryngoscope by interns or medical student.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Medical students and intern trainees with no prior experience in laryngoscopy on clinical rotation in the Department of Anesthesiology were recruited to participate. Written informed consent was obtained from all the study participants.', 'preAssignmentDetails': 'Trainees received a structured lecture in airway management followed by training in laryngoscopy skills on a mannequin, and required to demonstrate proficiency. Trainees were then randomly assigned to attempt their first two intubations on different patients using either the optical or rigid laryngoscope with a MacIntosh size 3 blade.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rigid Laryngoscope Group', 'description': 'Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope'}, {'id': 'BG001', 'title': 'Video Laryngoscope Group', 'description': 'Medical students or interns attempting intubation with Airtraq video laryngoscope'}, {'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': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', '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': '28', 'spread': '3', 'groupId': 'BG000'}, {'value': '27.5', 'spread': '2', 'groupId': 'BG001'}, {'value': '27.75', 'spread': '2.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The 15 in each group represents the medical student/ interns who are being studied.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-29', 'studyFirstSubmitDate': '2010-02-26', 'resultsFirstSubmitDate': '2012-03-02', 'studyFirstSubmitQcDate': '2010-03-02', 'lastUpdatePostDateStruct': {'date': '2013-12-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-20', 'studyFirstPostDateStruct': {'date': '2010-03-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful Endotracheal Intubation', 'timeFrame': '120 seconds', 'description': 'A successful placement of the endotracheal tube as defined by the presence of bilateral breath sounds and positive recording of end tidal carbon dioxide.'}], 'secondaryOutcomes': [{'measure': 'Time to Intubation', 'timeFrame': '120 seconds', 'description': 'Time to intubation is the time interval of blade insertion until the removal of the laryngoscope.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Teaching', 'Video Scope', 'Intubation'], 'conditions': ['Intubation Intraesophageal']}, 'descriptionModule': {'briefSummary': 'The use of the video laryngoscope to teach laryngoscopy will improve the performance of tracheal intubation done by novices because it will allow a shared view of the airway leading to a better feedback from the trainer to the trainee.', 'detailedDescription': 'A group of 30 fourth year medical students and interns rotating through the department of anesthesiology will be studied. Firstly, a standard lecture will be provided in which the description and importance of laryngoscopy and tracheal intubation will be explained. This will include descriptions of anatomy, relevant equipment and technique of tracheal intubation. Following the lecture , the students will be randomly allocated using sealed envelopes into two groups : a control group ( taught with a standard Macintosh Laryngoscope ) and a study group ( taught with the Airtraq video laryngoscope).Each group will receive a demonstration and verbal instruction on how to perform laryngoscopy and tracheal intubation by their instructor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Students:\n\nInclusion criteria for the medical student:\n\n* Medical student or intern rotating through the anesthesiology department\n\nExclusion criteria for the medical student:\n\n* Previous attempts of laryngoscopy in humans\n* Subject who refuses participation\n\nPatients:\n\nInclusion Criteria:\n\n* Age 18 -75 years of age\n* ASA PS I, II\n* Procedure that will require General anesthesia with tracheal intubation\n\nExclusion Criteria:\n\n* Age \\< 18 years old or greater than 75 years of age\n* Patient or student who refuses participation\n* ASA Physical status class III or greater\n* History of lung disease\n* History of obstructive sleep apnea\n* History of difficult intubation\n* Evidence of possible difficult airway (Mallampati Class \\>2, TMH distance \\<6 cm, mouth opening \\<4 cm and limited neck mobility)\n* Unanticipated difficult laryngoscopy (defined by inability of the attending anesthesiology to intubate after 2 attempts)\n* Patients at risk for aspiration\n* Patients with BMI greater than 35\n* Pregnant patients'}, 'identificationModule': {'nctId': 'NCT01080118', 'briefTitle': 'Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'A Clinical Trial on the Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices', 'orgStudyIdInfo': {'id': 'STU00007644'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'control group', 'description': 'Control group, taught with a standard Macintosh laryngoscope', 'interventionNames': ['Other: Control group, taught with a standard Macintosh laryngoscope']}, {'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Study group taught with the Airtraq video laryngoscope', 'interventionNames': ['Device: Airtraq']}], 'interventions': [{'name': 'Airtraq', 'type': 'DEVICE', 'description': 'Subjects were taught with the Airtraq video laryngoscope', 'armGroupLabels': ['Study group']}, {'name': 'Control group, taught with a standard Macintosh laryngoscope', 'type': 'OTHER', 'description': 'Subjects were taught how to use the Mackintosh blade first', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Gildasio DeOliveira, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gildasio De Oliveira, M.D. Principal Investigator', 'investigatorFullName': 'Gildasio De Oliveira', 'investigatorAffiliation': 'Northwestern University'}}}}