Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2026-01-03 @ 8:38 AM
Study NCT ID:
NCT03571295
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2018-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Videolaryngoscopy and Direct Laryngoscopy in Pediatric Airway Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2018-06-26', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'failure category of the first attempt', 'timeFrame': 'operation day', 'description': 'First attempt failed when esophageal intubation or oxygen desaturation \\< 90% occurred.'}], 'primaryOutcomes': [{'measure': 'first attempt success rate of endotracheal intubation', 'timeFrame': 'operation day', 'description': 'yes/no'}], 'secondaryOutcomes': [{'measure': 'total time for successful intubation', 'timeFrame': 'operation day', 'description': 'in sec'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric airway management', 'learning curve'], 'conditions': ['Airway Management', 'Videolaryngoscopy']}, 'descriptionModule': {'briefSummary': 'The investigators intended to evaluate first success rate and learning curve of trainee anesthetists performing direct and videolaryngoscopy in pediatric airway management.', 'detailedDescription': 'After obtaining written informed consent of 10 trainee anesthetists with non less than 24 months and not exceeding 60 months residency, use of the King Vision aBlade videolaryngoscope was demonstrated by presenting a 2 min instruction video. First endotracheal intubation by each trainee anesthetist was randomly allocated to either direct (DL) or King Vision aBlade videolaryngoscopy (KingVL). Then order of laryngoscopy type was alternating at least each trainee anesthetists performed 10 DL and 10 KingVL endotracheal intubations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1 to 2\n* written informed consent from both legal guardians\n* children who were scheduled for nonemergency surgery with requirement of endotracheal intubation\n\nExclusion Criteria:\n\n* known or predicted difficult airway\n* increased risk for pulmonary aspiration'}, 'identificationModule': {'nctId': 'NCT03571295', 'acronym': 'LearnaBlade', 'briefTitle': 'Comparison of Videolaryngoscopy and Direct Laryngoscopy in Pediatric Airway Management', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'A Comparison of Direct Laryngoscopy and King Vision® aBlade™ Videolaryngoscopy in Paediatric Airway Management: Success Rate and Learning Curve of Trainee Anaesthetists', 'orgStudyIdInfo': {'id': 'Learn a Blade 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'videolaryngoscopy', 'interventionNames': ['Device: King Vision aBlade']}, {'type': 'EXPERIMENTAL', 'label': 'direct laryngoscopy', 'interventionNames': ['Device: direct laryngoscopy']}], 'interventions': [{'name': 'King Vision aBlade', 'type': 'DEVICE', 'description': 'endotracheal intubation performed with King Vision aBlade', 'armGroupLabels': ['videolaryngoscopy']}, {'name': 'direct laryngoscopy', 'type': 'DEVICE', 'description': 'endotracheal intubation performed with direct laryngoscopy', 'armGroupLabels': ['direct laryngoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Johannes Gutenberg - Universität', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Nina Pirlich, Dr. med.', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}