Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-02-25 @ 5:49 PM
Study NCT ID:
NCT01835951
Status:
COMPLETED
Last Update Posted:
2013-10-24
First Post:
2013-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individual Versus Grouped Debriefing Approaches in Anaesthesia Crisis Simulation-Based Training. What Impact On The Technical Score ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-23', 'studyFirstSubmitDate': '2013-03-29', 'studyFirstSubmitQcDate': '2013-04-18', 'lastUpdatePostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score of technical competence', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Simulation', 'Debriefing', 'Anaesthesia Crisis Management', 'Cardiac Arrest', 'Pregnancy'], 'conditions': ['Cardiac Arrest', 'Pregnancy']}, 'descriptionModule': {'briefSummary': 'Simulation-based training is essential in learning or maintaining skills in high risk industry such as aviation and railway and in the medical field like anaesthesia. Debriefing following simulation is fundamental in order to reduce the emotional impact of the session and to asses the technical and non-technical skills (behavior). Even if the ideal debriefing method is still to be found, individual debriefing is considered as the gold standard but time consuming. The DEBRIEF-SIM study is a prospective, single blinded, multicentric and randomized study that will compare the individual (defined by learning couple resident and nurse) approach to a grouped (several couples) debriefing. The primary end point is to define the noninferiority of this approach compared to the individual one on the educational impact.\n\nThe learners will be debriefed according to their randomization after the first session, but will all undergo individual debriefing following the second session.', 'detailedDescription': 'Individual debriefing consists in a individual meeting between each subject of the study and the investigator to analyze the management of the anaesthesia crisis simulated.\n\nGrouped debriefing consists in the analysis by the investigator of the management of the anaesthesia crisis simulated in the presence of all the subjects included in the Grouped Debriefing group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Doctor:\n\n * resident in anesthesia and intensive care CHU Besançon and Dijon\n\nStudent nurse anesthetist:\n\n* Student nurse anesthesist 1st or 2nd year of school Besançon and Dijon\n\nExclusion Criteria:\n\n* Subjects incapable of giving consent: incapacitated (subjects under guardianship), minors (\\< 18 years)\n* Refusal to participate in the study\n* Refusal to sign the confidentiality clause'}, 'identificationModule': {'nctId': 'NCT01835951', 'acronym': 'DEBRIEF-SIM', 'briefTitle': 'Individual Versus Grouped Debriefing Approaches in Anaesthesia Crisis Simulation-Based Training. What Impact On The Technical Score ?', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Individual Versus Grouped Debriefing Approaches in Anaesthesia Crisis Simulation-Based Training. What Impact On The Technical Score ?', 'orgStudyIdInfo': {'id': 'EI/2012/028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Individual Debriefing', 'description': 'Individual debriefing consists in a individual meeting between each subject of the study and the investigator to analyze the management of the anaesthesia crisis simulated.', 'interventionNames': ['Other: Individual Debriefing']}, {'type': 'OTHER', 'label': 'Grouped Debriefing', 'description': 'Grouped debriefing consists in the analysis of the management of the anaesthesia crisis simulated in the presence of all the subject included in the Grouped Debriefing group.', 'interventionNames': ['Other: Grouped Debriefing']}], 'interventions': [{'name': 'Grouped Debriefing', 'type': 'OTHER', 'description': 'Debriefing consists in an analysis by the investigator of the management of the anaesthesia crisis simulated in the presence of all the subjects included in the Groupe Debriefing group.', 'armGroupLabels': ['Grouped Debriefing']}, {'name': 'Individual Debriefing', 'type': 'OTHER', 'description': 'Individual debriefing consists in a individual meeting between each subject of the study and the investigator to analyze the management of the anaesthesia crisis simulated.', 'armGroupLabels': ['Individual Debriefing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'Faculté de Franche-Comte des études de medecine et pharmaceutiques', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'overallOfficials': [{'name': 'Sébastien Pili-Floury', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculté de Franche-Comté des Etudes de Médecine et Pharmaceutiques'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesia-reanimation internal', 'investigatorFullName': 'Floriane CICERON', 'investigatorAffiliation': 'Centre Hospitalier Universitaire de Besancon'}}}}