- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00932906
Comparison of Different Automated External Defibrillation (AED) Training Methods
Comparison of Four Different AED Training Methods in Three Different Age Groups
This study is a prospective, randomized trial that compares the effectiveness and retention of four different training methods for the use of an AED:
A. Traditional instructor based learning;
B. The use of a personal manikin with a DVD training to practice the necessary AED skills;
C. The use of a personal manikin with a DVD training to practice the necessary AED skills and additional scenario training;
D. Watching a 2.5 minutes DVD which shows the use of an AED.
It is hypnotised that there are no differences between these training methods, in which case method D is most efficient to reach large number of people to learn BLS/AED skills.
There are two interesting target groups to reach:
- Younger people, as they might give the highest interest after training, as they normally live longer.
- Older people as they are member of the most important group in risk and have therefore a higher change of being a witness of cardiac arrest.
As there might be differences in the results between different training methods than can be related to age, each training group is distinguished to three different groups:
- 21 years of younger;
- between 21 and 50 years;
- older than 50 years.
It is hypnotised that there are no differences between younger and older students within each of the four training methods.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- willing to follow a BLS/AED course up to 2h
Exclusion Criteria:
- CPR training within the last five years
- professional health care provider
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Instructor based training; <21 years
The instructor based training is a 1.25 hour training as described by the ERC in their standard training program [ref; navragen bij Koen] and using the ERC PowerPoint presentation.
There is one manikin and one AED trainer per six students.
The group consists out of 12 students maximal, with one instructor per six students.
|
Instructor-based training meeting ERC directions
|
|
Placebo Comparator: Instructor based training; 21-50 years
The instructor based training is a 1.25 hour training as described by the ERC in their standard training program [ref; navragen bij Koen] and using the ERC PowerPoint presentation.
There is one manikin and one AED trainer per six students.
The group consists out of 12 students maximal, with one instructor per six students.
|
Instructor-based training meeting ERC directions
|
|
Placebo Comparator: Instructor based training; >50 years
The instructor based training is a 1.25 hour training as described by the ERC in their standard training program [ref; navragen bij Koen] and using the ERC PowerPoint presentation.
There is one manikin and one AED trainer per six students.
The group consists out of 12 students maximal, with one instructor per six students.
|
Instructor-based training meeting ERC directions
|
|
Experimental: Video Skill Training; <21 years
Participants practise AED skills, watching a 4.5-min video in a single uninterrupted session.
There is no instructor available.
The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock.
|
Self training with MiniAnne Training Kit
|
|
Experimental: Video Skill Training; 21-50 years
Participants practise AED skills, watching a 4.5-min video in a single uninterrupted session.
There is no instructor available.
The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock.
|
Self training with MiniAnne Training Kit
|
|
Experimental: Video Skill Training; >50 years
Participants practise AED skills, watching a 4.5-min video in a single uninterrupted session.
There is no instructor available.
The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock.
|
Self training with MiniAnne Training Kit
|
|
Experimental: Video scenario training; <21 years
Participants practises AED skills, watching a 9-min video in a single uninterrupted session.
There is no instructor available.
The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock, and additional two scenarios, in each of which they practice the BLS/AED procedure.
|
Self training with MiniAnne Training Kit
|
|
Experimental: Video scenario training; 21-50 years
Participants practises AED skills, watching a 9-min video in a single uninterrupted session.
There is no instructor available.
The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock, and additional two scenarios, in each of which they practice the BLS/AED procedure.
|
Self training with MiniAnne Training Kit
|
|
Experimental: Video scenario training; >50 years
Participants practises AED skills, watching a 9-min video in a single uninterrupted session.
There is no instructor available.
The video demonstrates the use of an AED; when to use it, how to turn it on, how to attach the electrodes, keeping distance and delivering a shock, and additional two scenarios, in each of which they practice the BLS/AED procedure.
|
Self training with MiniAnne Training Kit
|
|
Experimental: Video demonstration training; <21 years
Participants watch a 2.5 minutes video demonstration of the use of an AED, in a single uninterrupted session, without hands-on practice.
|
Self training with MiniAnne Training Kit
|
|
Experimental: Video demonstration training; 21-50 years
Participants watch a 2.5 minutes video demonstration of the use of an AED, in a single uninterrupted session, without hands-on practice.
|
Self training with MiniAnne Training Kit
|
|
Experimental: Video demonstration training; >50 years
Participants watch a 2.5 minutes video demonstration of the use of an AED, in a single uninterrupted session, without hands-on practice.
|
Self training with MiniAnne Training Kit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Kruskal-Wallis test
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wiebe de Vries, MSc, Doczero
- Study Director: Koenraad Monsieurs, Professor, University Hospital, Ghent
- Study Chair: Joost Bierens, Professor, VU Medical Centre
- Study Chair: Rudolph Koster, PhD MD, Academical Medical Centre Amsterdam
- Study Chair: Nigel M Turner, PhD MD, Medicine, Wilhelmina Children Hospital - University Medical Centre Utrecht
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Ed-2008-06
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.
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