Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2026-01-01 @ 4:12 PM
Study NCT ID:
NCT01215695
Status:
COMPLETED
Last Update Posted:
2017-09-08
First Post:
2010-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Video-laryngoscope With a Novel Video-stylet for Difficult Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rainer.lenhardt@louisville.edu', 'phone': '502-228-7517', 'title': 'Rainer Lenhardt, MD', 'organization': 'University Louisville'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)\n\nControl: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 0, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Intervention', 'description': 'Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).\n\naScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 0, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Unable to intubate', 'notes': 'Four patients could not be intubated with VLS and rigid stylet. These patients were subsequently intubated successfully using the alternative method with a complementary flexible tracheoscope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intubation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)\n\nControl: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).\n\naScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000', 'lowerLimit': '47', 'upperLimit': '89'}, {'value': '71', 'groupId': 'OG001', 'lowerLimit': '52', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '120 seconds', 'description': 'divided into time to successfully place the glidescope (visualization of the epiglottis), time to successfully insert the videostylet (passing through the cords) and time to verified placement of the ETT (as outlined above). Interim bag and mask time, if needed, will not be included in the intubation time. More than 5 attempts or 120 s are regarded as failure of intubation. If failure to secure the airway occurs with the GVL and videostylet, then conventional difficult intubation protocols approved by the University of Louisville Hospital will be implemented.', 'unitOfMeasure': 'time in seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Number of Intubation Attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)\n\nControl: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).\n\naScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '30 minutes', 'description': 'counted as each approach of the ETT to the glottic entrance.', 'unitOfMeasure': 'Number of intubation attempts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neck Movement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)\n\nControl: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).\n\naScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 minutes', 'description': 'One observer will video-record the entire intubation procedure. At a later time, an otherwise unrelated observer will watch the video-records and grade the neck movement during intubation. Neck movement will be classified as Grade 0: no neck movement, Grade 1: minimal neck movement, or Grade 2: moderate neck movement. Results are reported as total with mild, moderate, or severe neck movement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those participants with available data were analyzed for the assessment. All subjects reported had mild, moderate or severe neck movement.'}, {'type': 'SECONDARY', 'title': 'Laryngeal View Grade of 1 or 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)\n\nControl: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).\n\naScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 minutes', 'description': 'The laryngeal view as Grade 1 (full view of the glottis) or Grade 2 (glottis partly exposed, anterior commissure not seen) according to the method described by Cormack and Lehane (1984).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ease of Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)\n\nControl: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope'}, {'id': 'OG001', 'title': 'Intervention', 'description': 'Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).\n\naScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'spread': '23', 'groupId': 'OG000'}, {'value': '39', 'spread': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '2-4 hours after intubation', 'description': 'After completion of the procedure the intubator will be asked to score the ease of intubation. To do this, he/she will give a score from 0-100 with 0 being the easiest and 100 being the hardest.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)\n\nControl: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope'}, {'id': 'FG001', 'title': 'Intervention', 'description': 'Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).\n\naScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)\n\nControl: pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope'}, {'id': 'BG001', 'title': 'Intervention', 'description': 'Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).\n\naScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD): The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'spread': '13', 'groupId': 'BG000'}, {'value': '46', 'spread': '14', 'groupId': 'BG001'}, {'value': '45', 'spread': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-08', 'studyFirstSubmitDate': '2010-07-22', 'resultsFirstSubmitDate': '2017-04-09', 'studyFirstSubmitQcDate': '2010-10-05', 'lastUpdatePostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-27', 'studyFirstPostDateStruct': {'date': '2010-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation Time', 'timeFrame': '120 seconds', 'description': 'divided into time to successfully place the glidescope (visualization of the epiglottis), time to successfully insert the videostylet (passing through the cords) and time to verified placement of the ETT (as outlined above). Interim bag and mask time, if needed, will not be included in the intubation time. More than 5 attempts or 120 s are regarded as failure of intubation. If failure to secure the airway occurs with the GVL and videostylet, then conventional difficult intubation protocols approved by the University of Louisville Hospital will be implemented.'}], 'secondaryOutcomes': [{'measure': 'The Number of Intubation Attempts', 'timeFrame': '30 minutes', 'description': 'counted as each approach of the ETT to the glottic entrance.'}, {'measure': 'Neck Movement', 'timeFrame': '30 minutes', 'description': 'One observer will video-record the entire intubation procedure. At a later time, an otherwise unrelated observer will watch the video-records and grade the neck movement during intubation. Neck movement will be classified as Grade 0: no neck movement, Grade 1: minimal neck movement, or Grade 2: moderate neck movement. Results are reported as total with mild, moderate, or severe neck movement.'}, {'measure': 'Laryngeal View Grade of 1 or 2', 'timeFrame': '30 minutes', 'description': 'The laryngeal view as Grade 1 (full view of the glottis) or Grade 2 (glottis partly exposed, anterior commissure not seen) according to the method described by Cormack and Lehane (1984).'}, {'measure': 'Ease of Intubation', 'timeFrame': '2-4 hours after intubation', 'description': 'After completion of the procedure the intubator will be asked to score the ease of intubation. To do this, he/she will give a score from 0-100 with 0 being the easiest and 100 being the hardest.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intubation, Endotracheal', 'Endotracheal Intubation, adverse events'], 'conditions': ['Difficult Endotracheal Intubation']}, 'referencesModule': {'references': [{'pmid': '24842175', 'type': 'RESULT', 'citation': 'Lenhardt R, Burkhart MT, Brock GN, Kanchi-Kandadai S, Sharma R, Akca O. Is video laryngoscope-assisted flexible tracheoscope intubation feasible for patients with predicted difficult airway? A prospective, randomized clinical trial. Anesth Analg. 2014 Jun;118(6):1259-65. doi: 10.1213/ANE.0000000000000220.'}]}, 'descriptionModule': {'briefSummary': 'We propose to enroll 140 subjects scheduled for elective or urgent/emergent surgery with general anesthesia including endotracheal intubation. Patients qualify for the trial if they are considered a difficult airway case as determined by measurement of common predictive indices for difficult intubation (see inclusion criteria). All patients will be intubated with a GVL. Patients will be randomly assigned to either having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group) or with a flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group). The randomization will be stratified as to whether patients are categorized as predicted difficult airway or have an immobilized cervical spine (C-collar in place).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 35\n* Thyromental distance \\< 6 cm\n* Sterno-mental distance \\< 12 cm\n* Mallampati grade 3 and 4\n* Interincisor distance \\< 38 mm\n* Status of dentition: presence of buckteeth\n* Neck movement \\< 35°\n* Neck circumference \\>43 cm at the level of the thyroid cartilage\n* Patients with immobilized cervical spine (C-collar in place).\n* History of difficult laryngoscopy or intubation\n\nExclusion Criteria:\n\n* Full stomach\n* Hiatal hernia\n* Severe GERD (Gastroesophageal reflux disease)\n* Tumors of the upper airway'}, 'identificationModule': {'nctId': 'NCT01215695', 'briefTitle': 'Video-laryngoscope With a Novel Video-stylet for Difficult Intubation', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Feasibility of a Combined Use of a Video-laryngoscope With a Novel Video-stylet for Predicted Difficult Intubation', 'orgStudyIdInfo': {'id': 'UofL IRB #10.0300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients will be randomly assigned to having their ETT placed with use of a pre-formed stylet provided by the manufacturer of the GVL (control group)', 'interventionNames': ['Device: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Patients will be randomly assigned to either having their ETT placed with use of flexible, disposable tracheoscope (aScope, Ambu, Denmark) (intervention group).', 'interventionNames': ['Device: aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)']}], 'interventions': [{'name': 'aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)', 'type': 'DEVICE', 'otherNames': ['video-stylet'], 'description': 'The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.', 'armGroupLabels': ['Intervention']}, {'name': 'Control', 'type': 'DEVICE', 'description': 'pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville Hospital', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Rainer Lenhardt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Louisville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Rainer Lenhardt', 'investigatorAffiliation': 'University of Louisville'}}}}