Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT00876967
Status:
COMPLETED
Last Update Posted:
2010-03-31
First Post:
2009-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Three Laryngoscope Blades for Orotracheal Intubation in the Operating Room
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1040}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-30', 'studyFirstSubmitDate': '2009-04-06', 'studyFirstSubmitQcDate': '2009-04-06', 'lastUpdatePostDateStruct': {'date': '2010-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success of intubation at the first attempt', 'timeFrame': 'immediately'}], 'secondaryOutcomes': [{'measure': 'quality of laryngeal exposition (Cormack and Lehanne modify grade)', 'timeFrame': 'immediately'}, {'measure': 'duration to success intubation', 'timeFrame': 'immediately'}, {'measure': 'Intubation difficult Scale', 'timeFrame': 'Immediately'}, {'measure': 'result of intubation procedure', 'timeFrame': 'immediately'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anesthesiology', 'randomized', 'laryngoscope', 'intubation', 'laryngeal exposition', 'laryngoscope blades', 'plastic single use blade', 'metallic single use blade', 'metallic reusable blade', 'success to intubation at first attempt', 'Cormack and lehanne modify grade'], 'conditions': ['Intubation']}, 'referencesModule': {'references': [{'pmid': '23274619', 'type': 'DERIVED', 'citation': 'Buleon C, Parienti JJ, Lesage A, Grandin W, Pouliquen E, Flais F, Simonet T, Gerard JL, Hanouz JL. Comparison of plastic and metallic single-use and metallic reusable laryngoscope blades: a randomised controlled trial. Eur J Anaesthesiol. 2013 Apr;30(4):163-9. doi: 10.1097/EJA.0b013e32835c1cdb.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determinate if there is a difference in performance provided by three laryngoscope blades: plastic single use, metallic single use and metallic reusable blades.', 'detailedDescription': 'Primary outcome: success of intubation at the first attempt\n\nSecondary outcomes: quality of laryngeal exposition (Cormack and Lehanne modify grade), duration to success intubation, Intubation difficult Scale and result of intubation procedure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient age over 18 who need general anesthesia with orothracheal intubation\n\nExclusion Criteria:\n\n* patient age under 18 or major assist\n* presence of upper airway malformation or abnormality\n* cervical or facial trauma\n* previous difficult intubation known\n* no use of curare\n* Body Mass Index over 30kg/m2 if crush induction use'}, 'identificationModule': {'nctId': 'NCT00876967', 'acronym': 'Laryngotest', 'briefTitle': 'Comparison of Three Laryngoscope Blades for Orotracheal Intubation in the Operating Room', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Comparison of Performance of Three Laryngoscope Blades: Plastic Single Use, Metallic Single Use and Metallic Reusable Blades.', 'orgStudyIdInfo': {'id': 'Laryngotest'}, 'secondaryIdInfos': [{'id': 'N°ID RCB 2007-A00321-52'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'metallic single use blade', 'interventionNames': ['Device: metallic single use blade']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'plastic single use blade', 'interventionNames': ['Device: plastic single use blade']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'metallic reusable blade', 'interventionNames': ['Device: metallic reusable blade']}], 'interventions': [{'name': 'metallic single use blade', 'type': 'DEVICE', 'description': 'metallic single use blade', 'armGroupLabels': ['1']}, {'name': 'plastic single use blade', 'type': 'DEVICE', 'description': 'plastic single use blade', 'armGroupLabels': ['2']}, {'name': 'metallic reusable blade', 'type': 'DEVICE', 'description': 'metallic reusable blade', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'state': 'Basse-Normandie', 'country': 'France', 'facility': 'University Hospital Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'overallOfficials': [{'name': 'HANOUZ Jean-Luc, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Anesthesiology critical care SAMU departement, University Hospital of Caen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Hanouz JL PHD', 'oldOrganization': 'University Hospital, Caen'}}}}