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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03141528
Other study ID # Req-2016-00071
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 9, 2017
Est. completion date July 7, 2017

Study information

Verified date January 2020
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigates whether there is a difference in the BLS skills in first year medical students directly after training and three months later, when randomly assigned to self-learning versus instructor-led training courses.


Description:

This is a randomized controlled trial investigating whether self-learning versus instructor-led learning results in the same BLS skills in first year medical students directly after training and three months later.

When participants attend the "Erweiterte Erste Hilfe für Studierende der Humanmedizin" they will receive a short introduction about the study. The investigators will invite all first year students to participate in the study. As the study is voluntarily, participants need to sign a written informed consent. After that, the investigators will randomize the students to either group A or Group B. Group A will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching) and group B will train without supervision. The participants in group B will not be allowed to communicate with each other during the training and they will be prevented from watching each other. The training will take about 30 minutes for each group. Directly after the training each group will be tested and the printed report form from the Laerdal Skill Reporter will be obtained for each participant. In the test the students will perform CPR in a simulated scenario as a first responder. The scenario is: "A male person has collapsed at the railway station." The participant should start CPR as learned in the training. During the CPR a departmental research fellow will observe the study participants and record BLS/AED actions on a scoring sheet.

The investigators will record three cycles of two minutes CPR (with five times 30:2 compression : ventilation intervals, as recommended by the current international resuscitation guidelines). During the three cycles an AED will be delivered and the study participant has to apply the AED and deliver a shock - after three cycles the study terminates.

After the BLS/AED competence testing, both groups will continue the rest of their first aid course together and the first part of the study ends. Three months later, the investigators will repeat the same scenario over the same time interval and record the same parameters. At the end of the second testing, a short feedback will be provided on the BLS/AED competence and further practice will be provided to the students to improve their CPR competence. From this point forward no further data will be collected.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date July 7, 2017
Est. primary completion date March 2, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- First year medical students at the University of Bern participating in the course "Erweiterte Erste Hilfe für Studierende der Humanmedizin" with written informed consent.

Exclusion Criteria:

- Students with professional BLS-experience, unable to perform BLS, or missing informed consent will be excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Self-learning
Training without supervision
Instructor-led learning
Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)

Locations

Country Name City State
Switzerland University Hospital Inselspital Bern

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Correct Compressions The percentage of correct compressions obtained from the printed report from the Laerdal Skill Reporter. after first BLS course and 3 months later
Secondary Assessment of the Participants BLS Competences After Test Assessment of the participant's BLS competence by the study team after test.
Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely incompetent, no idea what to do, and 100mm = totally competent, cannot be done better.
after first BLS course and 3 months later
Secondary Self-assessment of the Participants BLS Competences Before Test The participants assessment of their own BLS competences. Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely incompetent, no idea what to do, and 100mm = totally competent, cannot be done better. before first BLS course and 3 months later
Secondary Assessment of the Teaching Method The participants assessment of the teaching method. Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely inefficient, and 100mm = totally efficient, nothing can be done better." after first BLS course
Secondary Average Ventilation Volume Ventilation volume from the printed report from the Laerdal Skill Reporter (LSR) after first BLS course and 3 months later
Secondary Number of Ventilations Per Minute Number of ventilations per minute from the printed report from the Laerdal Skill Reporter (LSR) after first BLS course and 3 months later
Secondary Percentage of Correct Ventilations Percentage of correct ventilations from the printed report from the Laerdal Skill Reporter (LSR) after first BLS course and 3 months later
Secondary Number of Participants Using Correct Ratio of Compressions:Ventilations the relationship between ventilations and compressions from the printed report from the Laerdal Skill Reporter (LSR). Ventilations - relationship 30 compressions and 2 ventilations. after first BLS course and 3 months later
Secondary Compression Depth Compression depth from the printed report from the Laerdal Skill Reporter (LSR) after first BLS course and 3 months later
Secondary Number of Compressions Per Minute Number of compressions per minute from the Laerdal Skill Reporter (LSR) after first BLS course and 3 months later
Secondary Compression Frequency Compression frequency from the Laerdal Skill Reporter (LSR). Compressions per minute ventilation break included. after first BLS course and 3 months later
Secondary Compressions Too Shallow Total percentage of Compressions too shallow from the Laerdal Skill Reporter (LSR) after first BLS course and 3 months later
Secondary False Hand Placement During Compressions False hand placement during compressions. after first BLS course and 3 months later
Secondary Incomplete Decompression Incomplete decompression from the Laerdal Skill Reporter (LSR) after first BLS course and 3 months later
Secondary Time From Start of Test Till Call for Help Time measured from the beginning of the test until the participant calls for help. after first BLS course and 3 months later
Secondary Time From Start of Test Till First Compression Time measured from the beginning of the test until the participant makes the first compression. after first BLS course and 3 months later
Secondary Time From Start of Test Till First Ventilation Time measured from the beginning of the test until the participant makes the first ventilation. after first BLS course and 3 months later
Secondary Time From Start of Test Till First Shock Time measured from the beginning of the test until the participant gives the first shock. after first BLS course and 3 months later
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