Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-02-20 @ 9:05 PM
Study NCT ID:
NCT02470195
Status:
COMPLETED
Last Update Posted:
2016-07-07
First Post:
2015-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Procedural Simulation for Difficult Airway Training in Anesthesiology Resident Education Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-05', 'studyFirstSubmitDate': '2015-05-28', 'studyFirstSubmitQcDate': '2015-06-09', 'lastUpdatePostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of use of airway devices between groups', 'timeFrame': '6 month', 'description': 'modification in the incidence of use of airway devices between workshop and control groups'}], 'secondaryOutcomes': [{'measure': 'confidence with airway device', 'timeFrame': '6 month', 'description': 'questionnaire of confidence with the usability of the devices. Scale from 0 to 10.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Behaviour']}, 'referencesModule': {'references': [{'pmid': '31371173', 'type': 'DERIVED', 'citation': 'Lilot M, Evain JN, Vincent A, Gaillard G, Chassard D, Mattatia L, Ripart J, Denoyel L, Bauer C, Robinson P, Duclos A, Lehot JJ, Rimmele T. [Simulation of difficult airway management for residents: prospective comparative study]. Braz J Anesthesiol. 2019 Jul-Aug;69(4):358-368. doi: 10.1016/j.bjan.2019.02.002. Epub 2019 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'Difficult airway management is a crucial point that may influence outcomes of patient in this critical situation. Education for this topic is of main importance for resident of anesthesiology. Procedural simulation workshop allows participant to use device dedicated to difficult airway management. Investigators included this workshop to a state education program of anesthesiology resident in second year and compared to their homonym in another state where no specific organized workshop is integrated to the education program.', 'detailedDescription': 'Difficult airway management is a crucial point that may influence outcome of patient in this critical situation. Education for this topic is of main importance for resident of anesthesiology. Procedural simulation workshop allows participant to use device dedicated to difficult airway management. The investigators included this workshop for smal groups of 6-10 anesthesiology resident from Rhône Alpes Auvergne french state. Participants were ask to fill out a questionnaire about their specific knowledge and experience of several devices usable in difficult airway management situation. The workshop was a small briefing as an introduction to the workshop and then small workshop of 20-45 min for specific procedural use of different devices for difficult airway management : Eischmann guide, LMA, supraglottic devices, fiberoptic with spontaneous breathing, cricothyroidotomy, jet ventilation, percutaneous tracheotomy... Investigator will compare at 6 month the incidence of use of the difficult airway devices between resident from rhone alpes auvergne following the workshop and resident from Montpellier that did not follow specific organized workshop.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Residents in 2nd year of anesthesiology residency in Rhones alpes auvergne and in Nîmes\n\nExclusion Criteria:\n\n* Exclusion demand from the participant'}, 'identificationModule': {'nctId': 'NCT02470195', 'acronym': 'PROSIDIAIR', 'briefTitle': 'Procedural Simulation for Difficult Airway Training in Anesthesiology Resident Education Program', 'organization': {'class': 'OTHER', 'fullName': 'Claude Bernard University'}, 'officialTitle': 'Anesthesiology Education Implementation by Procedural Simulation Workshop for Difficult Airway Management: a Controlled Interregional French Study', 'orgStudyIdInfo': {'id': 'CLESS PROSIDIAIR 2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'workshop', 'description': 'workshop of procedural simulation', 'interventionNames': ['Behavioral: workshop']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'no specific workshop of procedural simulation'}], 'interventions': [{'name': 'workshop', 'type': 'BEHAVIORAL', 'description': 'workshop for procedural simulation for education in difficult airway situation', 'armGroupLabels': ['workshop']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69007', 'city': 'Lyon', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'CLESS', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'marc Lilot, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CLESS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'data will be analysed by group, no plan to share data has been programmed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Claude Bernard University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Lilot Marc', 'investigatorAffiliation': 'Claude Bernard University'}}}}