Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-25 @ 3:59 PM
Study NCT ID:
NCT03685968
Status:
COMPLETED
Last Update Posted:
2019-01-08
First Post:
2018-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
King Vision® and GlideScope® in Difficult Airways
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Elizabeth.M.Gendel@uth.tmc.edu', 'phone': '+1 (713) 500-3587', 'title': 'Elizabeth M. Gendel', 'organization': 'The University of Texas Health Science Center at Houston (UTHealth)'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Postoperatively in the PACU', 'description': '(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up.\n\nGroup B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up.\n\nGroup C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.', 'eventGroups': [{'id': 'EG000', 'title': 'Glidescope AVL', 'description': 'Video laryngoscopes: Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 75, 'otherNumAffected': 26, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'King Vision Channeled VL', 'description': 'Video laryngoscopes: Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 75, 'otherNumAffected': 23, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'King Vision Non-Channeled (Standard) VL', 'description': 'Video laryngoscopes: Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 75, 'otherNumAffected': 22, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hoarseness', 'notes': 'Hoarseness in voice postoperatively', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore Mouth', 'notes': 'Sore Mouth postoperatively', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore neck', 'notes': 'Sore neck postoperatively', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore jaw', 'notes': 'Sore jaw postoperatively', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphonia', 'notes': 'Dysphonia postoperatively', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'notes': 'Dysphagia postoperatively', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alteration of tongue', 'notes': 'Alteration of tongue postoperatively', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glidescope AVL', 'description': 'Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL.'}, {'id': 'OG001', 'title': 'King Vision Channeled VL', 'description': 'Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL.'}, {'id': 'OG002', 'title': 'King Vision Non-Channeled (Standard) VL', 'description': 'Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During laryngoscopy and endotracheal tube placement', 'description': 'The overall intubation success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glidescope AVL', 'description': 'Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL.'}, {'id': 'OG001', 'title': 'King Vision Channeled VL', 'description': 'Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL.'}, {'id': 'OG002', 'title': 'King Vision Non-Channeled (Standard) VL', 'description': 'Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During laryngoscopy and endotracheal tube placement', 'description': 'The overall first-attempt success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Glidescope AVL', 'description': 'Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL.'}, {'id': 'OG001', 'title': 'King Vision Channeled VL', 'description': 'Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL.'}, {'id': 'OG002', 'title': 'King Vision Non-Channeled (Standard) VL', 'description': 'Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.1', 'spread': '27.4', 'groupId': 'OG000'}, {'value': '44.9', 'spread': '21.5', 'groupId': 'OG001'}, {'value': '47.0', 'spread': '24.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During laryngoscopy and endotracheal tube placement', 'description': 'Total time for placing the endotracheal tube (ETT) through the vocal cords', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Group A: 3 participants excluded due to protocol deviations. Group B: 8 participants excluded due to protocol deviations, 2 participant had failed intubation, 4 participants had device failure.\n\nGroup C: 2 participants excluded due to protocol deviations, 1 participant had device failure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Glidescope AVL', 'description': 'Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL.'}, {'id': 'FG001', 'title': 'King Vision Channeled VL', 'description': 'Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL.'}, {'id': 'FG002', 'title': 'King Vision Non-Channeled (Standard) VL', 'description': 'Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were enrolled from the adult surgical operating rooms of 2 academic hospitals, Lyndon Baines Johnson General Hospital and Memorial Hermann Hospital - Texas Medical Center, in Houston, TX from August 2013 to December 2015.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '225', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Glidescope AVL', 'description': 'Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL.'}, {'id': 'BG001', 'title': 'King Vision Channeled VL', 'description': 'Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL.'}, {'id': 'BG002', 'title': 'King Vision Non-Channeled (Standard) VL', 'description': 'Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade.'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '196', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '48.0', 'spread': '15.2', 'groupId': 'BG001'}, {'value': '50.0', 'spread': '14.2', 'groupId': 'BG002'}, {'value': '48.7', 'spread': '13.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height (in)', 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '66.4', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '66.4', 'spread': '4.2', 'groupId': 'BG002'}, {'value': '66.5', 'spread': '4.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'inches', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '117.5', 'spread': '20.3', 'groupId': 'BG000'}, {'value': '116.2', 'spread': '25.5', 'groupId': 'BG001'}, {'value': '116.8', 'spread': '21.5', 'groupId': 'BG002'}, {'value': '116.8', 'spread': '22.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI (kg/m2)', 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '41.4', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '41.1', 'spread': '8.5', 'groupId': 'BG002'}, {'value': '41.2', 'spread': '8.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram per meter square', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Neck Circumference (cm)', 'classes': [{'categories': [{'measurements': [{'value': '47.1', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '47.1', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '47.9', 'spread': '4.3', 'groupId': 'BG002'}, {'value': '47.3', 'spread': '4.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Interincisor distance (cm)', 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '4.1', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '4.1', 'spread': '1.0', 'groupId': 'BG002'}, {'value': '4.1', 'spread': '0.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Thyromental distance (cm)', 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '6.8', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '7.1', 'spread': '1.7', 'groupId': 'BG002'}, {'value': '6.9', 'spread': '1.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sternomental distance (cm)', 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '13.6', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '13.7', 'spread': '2.1', 'groupId': 'BG002'}, {'value': '13.5', 'spread': '2.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2015-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-04', 'studyFirstSubmitDate': '2018-09-24', 'resultsFirstSubmitDate': '2018-11-07', 'studyFirstSubmitQcDate': '2018-09-24', 'lastUpdatePostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-10', 'studyFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL', 'timeFrame': 'During laryngoscopy and endotracheal tube placement', 'description': 'Total time for placing the endotracheal tube (ETT) through the vocal cords'}], 'primaryOutcomes': [{'measure': 'Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL', 'timeFrame': 'During laryngoscopy and endotracheal tube placement', 'description': 'The overall intubation success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL'}], 'secondaryOutcomes': [{'measure': 'First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL', 'timeFrame': 'During laryngoscopy and endotracheal tube placement', 'description': 'The overall first-attempt success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Airway Management']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Hagberg CA, Iannucci D, Goodrich A. A comparison of the glottic view obtained with the Macintosh Video Laryngoscope in anesthetized, paralyzed, apneic patients. Direct view vs video monitor. Anesthesiology 2003; 103: A1501.'}, {'type': 'BACKGROUND', 'citation': 'Hagberg C, Matuszczak M, Ellis S, et al. A randomized comparison of laryngoscopy techniques using the video laryngoscope and the traditional Macintosh laryngoscope in obese patients. Anesthesiology 2005; 103: A1420.'}, {'type': 'BACKGROUND', 'citation': 'Hagberg C, Vogt-Harenkamp C, Bogomolny Y, et al. A comparison of laryngoscopy techniques using the video laryngoscope and the traditional Macintosh laryngoscope in potentially difficult to intubate patients. Anesth Analg 2005; 100: S-212.'}]}, 'descriptionModule': {'briefSummary': 'There are several advantages of video laryngoscopy; especially their ability to provide superior glottis visualization, as compared to traditional laryngoscopy.1-3 The purpose of this three arm study was to compare the safety and efficacy of the King Vision® Video Intubation Systems (AMBU-King Systems, Denmark) to the Cobalt GlideScope® (Verathon Medical Inc., USA) in patients with anticipated difficult airways.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Over 18 years of age\n* Mallampati III-IV\n* Neck circumference \\> 43cm\n* Reduced mouth opening (\\< 4cm) or 3 Finger breath's (patient's own)\n* Thyromental distance \\< 6cm\n\nExclusion Criteria:\n\n* Mallampati I-II\n* Neck circumference \\< 43cm\n* Documented 'easy' intubation\n* Previous history of failed intubation and failed bag-mask ventilation\n* Under 18 years of age\n* ASA IV\n* Known unstable cervical spine injury\n* Presentation for an emergency surgical procedure"}, 'identificationModule': {'nctId': 'NCT03685968', 'briefTitle': 'King Vision® and GlideScope® in Difficult Airways', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'A Comparison of the King Vision® Channeled, King Vision® Non-Channeled, and Glidescope® Video Intubation Systems in Patients at Risk for Difficult Intubation - A Pilot Study', 'orgStudyIdInfo': {'id': 'HSC-MS-13-0024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glidescope AVL', 'interventionNames': ['Device: Video laryngoscopes']}, {'type': 'EXPERIMENTAL', 'label': 'King Vision Channeled VL', 'interventionNames': ['Device: Video laryngoscopes']}, {'type': 'EXPERIMENTAL', 'label': 'King Vision Non-Channeled (Standard) VL', 'interventionNames': ['Device: Video laryngoscopes']}], 'interventions': [{'name': 'Video laryngoscopes', 'type': 'DEVICE', 'description': 'Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.', 'armGroupLabels': ['Glidescope AVL', 'King Vision Channeled VL', 'King Vision Non-Channeled (Standard) VL']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Carin A Hagberg, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The University of Texas MD Anderson Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'King Systems Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Academic Officer and Division Head of Anesthesiology, Critical Care, and Pain Medicine', 'investigatorFullName': 'Carin A. Hagberg', 'investigatorAffiliation': 'M.D. Anderson Cancer Center'}}}}