Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2026-01-22 @ 10:08 AM
Study NCT ID:
NCT03773861
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2018-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Group Size in Basic Life Support (BLS) Courses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2018-11-28', 'studyFirstSubmitQcDate': '2018-12-11', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The threshold of number of course participants in a BLS educational session', 'timeFrame': 'BLS educational session 10 minutes', 'description': 'How many volunteers can be overseen by one instructor who still is able to correctly identify and correct serious BLS errors of all course participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Educational Problems', 'Resuscitation']}, 'referencesModule': {'references': [{'pmid': '26477420', 'type': 'BACKGROUND', 'citation': 'Perkins GD, Handley AJ, Koster RW, Castren M, Smyth MA, Olasveengen T, Monsieurs KG, Raffay V, Grasner JT, Wenzel V, Ristagno G, Soar J; Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation. Resuscitation. 2015 Oct;95:81-99. doi: 10.1016/j.resuscitation.2015.07.015. Epub 2015 Oct 15. No abstract available.'}, {'pmid': '26184655', 'type': 'BACKGROUND', 'citation': 'Beck S, Issleib M, Daubmann A, Zollner C. Peer education for BLS-training in schools? Results of a randomized-controlled, noninferiority trial. Resuscitation. 2015 Sep;94:85-90. doi: 10.1016/j.resuscitation.2015.06.026. Epub 2015 Jul 14.'}, {'pmid': '21338967', 'type': 'BACKGROUND', 'citation': 'Cendan JC, Silver M, Ben-David K. Changing the student clerkship from traditional lectures to small group case-based sessions benefits the student and the faculty. J Surg Educ. 2011 Mar-Apr;68(2):117-20. doi: 10.1016/j.jsurg.2010.09.011.'}, {'pmid': '14623795', 'type': 'BACKGROUND', 'citation': 'Chamberlain DA, Hazinski MF; European Resuscitation Council; American Heart Association; Heart and Stroke Foundation of Canada; Resuscitation Council of Southern Africa; Australia and New Zealand Resuscitation Council; Consejo Latino-Americano de Resusucitacion. Education in resuscitation: an ILCOR symposium: Utstein Abbey: Stavanger, Norway: June 22-24, 2001. Circulation. 2003 Nov 18;108(20):2575-94. doi: 10.1161/01.CIR.0000099898.11954.3B. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Basic Life Support (BLS) is important for outcome in cardiac arrest.Therefore, it is crucial to improve the quality of education in resuscitation training. Better training will eventually lead to more effective CPR skills in course participants. BLS courses in both international resuscitation associations (European Resuscitation Council and American Heart Association are typically taught in small groups of 6 participants. In reality group sizes of up to 10 participants are used, because these courses are highly demanded and cost intensive. There is no evidence for the effective group size to be clinical and cost effective. Therefore the investigators perform this prospective study to determine the maximum number of participants an instructor can oversee without missing more than 20% of errors made during an instructional BLS session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active BLS- Instructors at the Bern Simulation and CPR-Center (BeSiC), at the Bern University Hospital, Bern, Switzerland\n\nExclusion Criteria:\n\n* Decline to participate'}, 'identificationModule': {'nctId': 'NCT03773861', 'briefTitle': 'Group Size in Basic Life Support (BLS) Courses', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Determining a Threshold for the Clinical and Cost-effectiveness of Group Size During Basic Life Support Courses', 'orgStudyIdInfo': {'id': 'Req- 2017- 00577'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Participants', 'description': 'Active BLS- Instructors at the Bern Simulation and CPR- Center (BeSiC), at the Bern University Hospital, Bern, Switzerland. Participants have to oversee a BLS instructional session, where standardized errors are performed by trained volunteers.', 'interventionNames': ['Other: errors made in one BLS session']}], 'interventions': [{'name': 'errors made in one BLS session', 'type': 'OTHER', 'description': 'BLS instructors have to oversee a standardized BLS training session, where standardized errors are made by trained volunteers.', 'armGroupLabels': ['Participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Sabine Nabecker, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Bern, Bern, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}