Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-04 @ 1:47 PM
Study NCT ID:
NCT00803751
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2008-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of the Infant Truview EVO2 Video Laryngoscope and the Macintosh Laryngoscope in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maria.matuszczak@uth.tmc.edu', 'phone': '713-498-2768', 'title': 'Maria Matuszczak', 'organization': 'UT Medical School, Houston'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Truview Intubation First Then With Macintosh', 'description': 'Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade', 'otherNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Macintosh Intubation First Followed by Truview Intubation', 'description': 'Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quality of Laryngeal View Obtained on Comarck Lehane Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truview', 'description': 'This group has data for all the truview intubations'}, {'id': 'OG001', 'title': 'Mac Blade', 'description': 'This groups has data with all the mac blade intubations'}], 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '2a', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '2b', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'during laryngoscopy prior to intubation. Few minutes before intubation', 'description': 'The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Intubation Attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truview', 'description': 'This group has data for all the truview intubations'}, {'id': 'OG001', 'title': 'Mac Blade', 'description': 'This groups has data with all the mac blade intubations'}], 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'during intubation prior to surgery', 'description': 'Number of participants with the indicated number of intubation attempts (1/2/3)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Taken for Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truview', 'description': 'This group has data for all the truview intubations'}, {'id': 'OG001', 'title': 'Mac Blade', 'description': 'This groups has data with all the mac blade intubations'}], 'classes': [{'categories': [{'measurements': [{'value': '25.23', 'spread': '11.09', 'groupId': 'OG000'}, {'value': '28.33', 'spread': '12.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.36', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'throughout the intubation procedure', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'POGO Score With 1st Laryngoscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truview', 'description': 'This group has data for all the truview intubations'}, {'id': 'OG001', 'title': 'Mac Blade', 'description': 'This groups has data with all the mac blade intubations'}], 'classes': [{'categories': [{'measurements': [{'value': '93.65', 'spread': '15.72', 'groupId': 'OG000'}, {'value': '73.81', 'spread': '23.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Before patient is intubated (few minutes before intubation)', 'description': 'POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening.', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Quality of Laryngeal View Obtained With 2nd Laryngoscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truview', 'description': 'This group has data for all the truview intubations'}, {'id': 'OG001', 'title': 'Mac Blade', 'description': 'This groups has data with all the mac blade intubations'}], 'classes': [{'title': '1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': '2a', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '2b', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'during laryngoscopy prior to intubation (few minutes prior to intubation)', 'description': 'The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'POGO Score With 2nd Laryngoscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Truview', 'description': 'This group has data for all the truview intubations'}, {'id': 'OG001', 'title': 'Mac Blade', 'description': 'This groups has data with all the mac blade intubations'}], 'classes': [{'categories': [{'measurements': [{'value': '74.3', 'spread': '25.1', 'groupId': 'OG000'}, {'value': '98.0', 'spread': '8.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Before patient is intubated', 'description': 'POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening.', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Truview Intubation First Then With Macintosh', 'description': 'Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade'}, {'id': 'FG001', 'title': 'Macintosh Intubation First Followed by Truview Intubation', 'description': 'Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The patients were recruited from pediatric day surgery.', 'preAssignmentDetails': 'There were 11 patients excluded from the trial due to incomplete data.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Truview Intubation First Then With Macintosh', 'description': 'Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade'}, {'id': 'BG001', 'title': 'Macintosh Intubation First Followed by Truview Intubation', 'description': 'Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', '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': '6.35', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '6.42', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '6.39', 'spread': '3.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', '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': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-03', 'studyFirstSubmitDate': '2008-12-05', 'resultsFirstSubmitDate': '2011-02-18', 'studyFirstSubmitQcDate': '2008-12-05', 'lastUpdatePostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-03', 'studyFirstPostDateStruct': {'date': '2008-12-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Laryngeal View Obtained on Comarck Lehane Classification', 'timeFrame': 'during laryngoscopy prior to intubation. Few minutes before intubation', 'description': 'The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.'}, {'measure': 'Number of Intubation Attempts', 'timeFrame': 'during intubation prior to surgery', 'description': 'Number of participants with the indicated number of intubation attempts (1/2/3)'}, {'measure': 'Quality of Laryngeal View Obtained With 2nd Laryngoscopy', 'timeFrame': 'during laryngoscopy prior to intubation (few minutes prior to intubation)', 'description': 'The view obtained when we do laryngoscopy. The Comarck Lehane classification is as follows: 1) Most of the glottis is seen; 2a) Only the posterior part of the glottis is visible; 2b) The epiglottis is visible, but none of the glottis can be seen; 3) Not even the epiglottis is visible.'}], 'secondaryOutcomes': [{'measure': 'Time Taken for Intubation', 'timeFrame': 'throughout the intubation procedure'}, {'measure': 'POGO Score With 1st Laryngoscopy', 'timeFrame': 'Before patient is intubated (few minutes before intubation)', 'description': 'POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening.'}, {'measure': 'POGO Score With 2nd Laryngoscopy', 'timeFrame': 'Before patient is intubated', 'description': 'POGO score is the percent of glottic opening observed during laryngoscopy. 100% POGO score indicates a full view of glottic opening and 0% POGO score indicates no glottic opening.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Laryngoscopy [E04.580.373]'], 'conditions': ['Laryngoscopy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.truphatek.com/', 'label': "Truphatek - Manufacturer's website"}]}, 'descriptionModule': {'briefSummary': 'This study is intended to examine the effectiveness of a new type of laryngoscope, the Truview EVO2, in an infant patient population. They device will be tested against the current clinical standard, the Macintosh laryngoscope, in patients undergoing surgery at our hospital in terms of ease of use, view obtained of the vocal cords, and ability to place an endotracheal tube.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age less than one year\n2. Requiring general anesthesia and orotracheal intubation\n3. Weight less than 10 kg\n4. ASA class 1-3\n\nExclusion Criteria:\n\n1. Documented difficult airway\n2. Facial deformities'}, 'identificationModule': {'nctId': 'NCT00803751', 'acronym': 'Truview', 'briefTitle': 'A Comparison of the Infant Truview EVO2 Video Laryngoscope and the Macintosh Laryngoscope in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'A Comparison of the Infant Truview EVO2 Video Laryngoscope and the Macintosh Laryngoscope in Pediatric Patients', 'orgStudyIdInfo': {'id': 'Infant Truview'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Truview intubation', 'description': 'Receive laryngoscopy with Truview first and is immediately followed by laryngoscopy and intubation with Macintosh', 'interventionNames': ['Device: Truview EVO2 laryngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Macintosh intubation', 'description': 'Macintosh blade will be used first followed by laryngoscopy and intubation with the truview', 'interventionNames': ['Device: Macintosh laryngoscope']}], 'interventions': [{'name': 'Truview EVO2 laryngoscope', 'type': 'DEVICE', 'description': 'will use the Truview laryngoscope instead of the traditional Macintosh laryngoscope', 'armGroupLabels': ['Truview intubation']}, {'name': 'Macintosh laryngoscope', 'type': 'DEVICE', 'description': 'Intubation using the traditional Macintosh laryngoscope', 'armGroupLabels': ['Macintosh intubation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann Hospital - Texas Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Maria Matuszczak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor - Anesthesiology', 'investigatorFullName': 'Maria Matuszczak', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}