Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 4:07 PM
Study NCT ID:
NCT00884559
Status:
COMPLETED
Last Update Posted:
2012-08-27
First Post:
2009-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Leadership Instructions Improve Cardiopulmonary Resuscitation in a High Fidelity Simulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 237}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-24', 'studyFirstSubmitDate': '2009-04-17', 'studyFirstSubmitQcDate': '2009-04-17', 'lastUpdatePostDateStruct': {'date': '2012-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hands-on time in the first 180 seconds after the onset of the cardiac arrest and the time elapsed until cardiopulmonary resuscitation is started.', 'timeFrame': '180 sec after start of CPR'}], 'secondaryOutcomes': [{'measure': 'The effectiveness of the technical and leadership instructions', 'timeFrame': '180 sec after starting CPR'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Leadership', 'Team building', 'Resuscitation'], 'conditions': ['Cardiopulmonary Resuscitations']}, 'descriptionModule': {'briefSummary': 'Whether teaching leadership with a short debriefing has a positive influence on the performance of cardiopulmonary resuscitation remains largely unknown. The investigators will assess the sustained efficacy of a short leadership debriefing compared to a technical debriefing in a high fidelity simulated cardiopulmonary resuscitation.', 'detailedDescription': 'Context:\n\nWhether the performance of cardiopulmonary resuscitation can be positively influenced by teaching leadership with a short debriefing remains largely unknown\n\nObjective:\n\nTo test the hypothesis that (1) leadership instruction are effective and (2) improved leadership results in better performance in a high fidelity simulated cardiopulmonary resuscitation.\n\nDesign:\n\nProspective, randomized-controlled superiority trial\n\nSetting:\n\nSimulator Center of the University Hospital Basel in Switzerland\n\nPatients or Other Participants:\n\n237 volunteer medical students in teams of 3\n\nIntervention:\n\nDuring a baseline visit, the medical students participate in a video-taped simulated witnessed cardiac arrest. Participants are randomized to receive thereafter a short video-assisted debriefing focusing either on correct positions of arms and shoulders (technical debriefing) or on leadership and communication to enhance team coordination (leadership debriefing). A follow-up simulation is conducted after 4 months. Leadership utterances, technical skills and the resuscitation performance of the teams are compared based on videotapes coded by two independent researchers.\n\nMain Outcome Measures:\n\nThe primary outcomes for this study are the amount of hands-on time in the first 180 seconds after the onset of the cardiac arrest and the time elapsed until cardiopulmonary resuscitation was started. Secondary endpoints are the effectiveness of the technical and leadership instructions, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* volunteer medical students\n\nExclusion Criteria:\n\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT00884559', 'briefTitle': 'Leadership Instructions Improve Cardiopulmonary Resuscitation in a High Fidelity Simulation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Brief Leadership Instructions Improve Cardiopulmonary Resuscitation in a High Fidelity Simulation: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'ekbb_SH_103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Technical', 'description': 'Technical Instructions', 'interventionNames': ['Other: instruction']}, {'type': 'EXPERIMENTAL', 'label': 'Leadership', 'description': 'Leadership-Instructions', 'interventionNames': ['Other: instruction']}], 'interventions': [{'name': 'instruction', 'type': 'OTHER', 'description': 'Debriefing', 'armGroupLabels': ['Leadership', 'Technical']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Sabina Hunziker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}, {'name': 'Stephan Marsch, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Intensive Care unit, University Hospital Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}