- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03773861
Group Size in Basic Life Support (BLS) Courses
February 2, 2021 updated by: University Hospital Inselspital, Berne
Determining a Threshold for the Clinical and Cost-effectiveness of Group Size During Basic Life Support Courses
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bern, Switzerland
- University Hospital Bern
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Active BLS- Instructors at the Bern Simulation and CPR-Center (BeSiC), at the Bern University Hospital, Bern, Switzerland
Exclusion Criteria:
- Decline to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Participants
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.
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BLS instructors have to oversee a standardized BLS training session, where standardized errors are made by trained volunteers.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The threshold of number of course participants in a BLS educational session
Time Frame: BLS educational session 10 minutes
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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.
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BLS educational session 10 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sabine Nabecker, M.D., University Hospital Bern, Bern, Switzerland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 10, 2018
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
November 28, 2018
First Submitted That Met QC Criteria
December 11, 2018
First Posted (Actual)
December 12, 2018
Study Record Updates
Last Update Posted (Actual)
February 3, 2021
Last Update Submitted That Met QC Criteria
February 2, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- Req- 2017- 00577
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.