Educational ProblemsNCT03773861
Group Size in Basic Life Support (BLS) Courses
A study testing errors made in one BLS session in people with Educational Problems and Resuscitation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Educational Problems, Resuscitation
- What is being tested?
- errors made in one BLS session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Dec 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active BLS- Instructors at the Bern Simulation and CPR-Center (BeSiC), at the Bern University Hospital, Bern, Switzerland
Who cannot join
- Decline to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Educational Problems, Resuscitation
- Being tested
- errors made in one BLS session
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
errors made in one BLS sessionOther
BLS instructors have to oversee a standardized BLS training session, where standardized errors are made by trained volunteers.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Other | 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. Receives: Other: errors made in one BLS session |
What is being measured
The primary outcome is the main question the study is designed to answer.
The threshold of number of course participants in a BLS educational session
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.
Measured: BLS educational session 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start10 Dec 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Educational ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Nabecker, M.D., Principal investigator, University Hospital Bern, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773861
- Sponsor's protocol ID
- Req- 2017- 00577
- Status last verified
- Feb 2021
- First submitted
- 28 Nov 2018
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 26477420Beck 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.
PubMed 26184655Cendan 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.
PubMed 21338967Chamberlain 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.
PubMed 14623795
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining a Threshold for the Clinical and Cost-effectiveness of Group Size During Basic Life Support Courses
- ClinicalTrials.gov ID
- NCT03773861
- Acronym / sponsor ID
- Req- 2017- 00577
- Conditions
- Educational Problems, Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Other | Other: errors made in one BLS sessionActive 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active BLS- Instructors at the Bern Simulation and CPR-Center (BeSiC), at the Bern University Hospital, Bern, Switzerland
Key exclusion criteria (1 listed)
- Decline to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| errors made in one BLS sessionBLS instructors have to oversee a standardized BLS training session, where standardized errors are made by trained volunteers. | Other | Participants |
Primary outcome
The threshold of number of course participants in a BLS educational session
Time frame: BLS educational session 10 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Background: PubMed 26477420Perkins 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.
- Background: PubMed 26184655Beck 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.
- Background: PubMed 21338967Cendan 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.
- Background: PubMed 14623795Chamberlain 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Nabecker, M.D. principal investigator
University Hospital Bern, Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing errors made in one BLS session in people with Educational Problems and Resuscitation, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The threshold of number of course participants in a BLS educational session (time frame: BLS educational session 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03773861, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.