Cardiopulmonary Arrest With Successful ResuscitationNCT03729037
Cardiopulmonary Resuscitation Self-training
A study testing CPR self-training in people with Cardiopulmonary Arrest With Successful Resuscitation, run by Pontificia Universidade Católica do Rio Grande do Sul.
Trial summary
Participants were 45 first-year medical students randomly assigned to cardiopulmonary resuscitation (CPR) self-training using either a video-based presentation or a serious game developed in a 3D learning environment for up to 20 min. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Arrest With Successful Resuscitation
- What is being tested?
- CPR self-training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2016to 20 Aug 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a medical student;
- Voluntary participation;
- No previous participation in CPR training.
Who cannot join
- Previous participation in CPR training.
- Refusal to participate.
- Not being enrolled in medical school.
About this study
Official title: Comparative Evaluation of Video-based On-line Course vs. Serious Game for Training Medical Students in Cardiopulmonary Resuscitation: a Randomized Trial
Participants were 45 first-year medical students randomly assigned to cardiopulmonary resuscitation (CPR) self-training using either a video-based presentation or a serious game developed in a 3D learning environment for up to 20 min. Each participant was evaluated on a written, multiple-choice test (theoretical test) and then on a scenario of cardiac arrest (practical test) before and after exposure to the self-learning methods.
Read the detailed description
A prospective, simulation-based, randomised controlled trial was conducted. Participants were randomised to the video group watched a video-recorded lecture on the management of adult cardiac arrest, while participants randomised to the game group played a serious game on the same topic.
The video was developed based on a previously recorded Keynote presentation (version 6.6.2, Apple Inc.) with the addition of voice-over narration of the events. The video was edited to contain the same information as provided in the serious game. The learning environment simulated an urban public space where the player should identify a victim of cardiac arrest and perform CPR manoeuvres. The game was designed to be a CPR self-learning tool for both health professionals and the lay public. The game involved only one rescuer without access to a portable defibrillator. During the game, the player should identify the victim, diagnose cardiac arrest correctly and initiate CPR as early as possible. The actions of the player were guided throughout the game by step-by-step instructions that should be followed to save the victim's life and to score on the game. Whenever the manoeuvres were not performed correctly, the victim died and the game automatically restarted from the beginning.
After exposure to the self-learning methods, participants were reassessed individually for their theoretical knowledge on a written, 10-question, multiple-choice test (theoretical post-test) and for their practical performance by three examiners, blinded to group assignment, who independently rated the participants' actions on a 10-min simulated scenario of cardiac arrest using a CPR training manikin (practical post-test).
Simulated scenario The same simulated scenario was used for pre-exposure and post-exposure practical evaluation. When the student entered the simulation room, a manikin was lying on the floor, simulating a person lying on the street, unconscious, not responding to stimulation and with no respiratory effort or pulse. The student was alone without access to medical equipment such as a defibrillator. Participants were expected to recognise the cardiac arrest, call the emergency services, and initiate chest compressions and ventilations as soon as possible for at least two cycles. A 10-min time limit was set for each simulation session.
- Being tested
- CPR self-training
- Keywords
- Virtual learning, Educational technology, Medical education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPR self-trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Serious game | Experimental | Intervention: CPR self-training with serious game. Receives: Other: CPR self-training |
| Training video | Active comparator | Intervention: CPR self-training with Keynote presentation with the addition of voice-over narration. Receives: Other: CPR self-training |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Heart Association (AHA) Guidelines for CPR
Mean performance score of students on each (theoretical and practical) test for each study arm.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start10 Aug 2016
- Primary completion20 Jun 2017
- Study completion20 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary Arrest With Successful ResuscitationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David P Sena, MD, PhD, Principal investigator, Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729037
- Sponsor's protocol ID
- 1818537
- Status last verified
- Oct 2018
- First submitted
- 31 Oct 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bhanji F, Donoghue AJ, Wolff MS, Flores GE, Halamek LP, Berman JM, Sinz EH, Cheng A. Part 14: Education: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S561-73. doi: 10.1161/CIR.0000000000000268. No abstract available.
PubMed 26473002Thorne CJ, Lockey AS, Bullock I, Hampshire S, Begum-Ali S, Perkins GD; Advanced Life Support Subcommittee of the Resuscitation Council (UK). E-learning in advanced life support--an evaluation by the Resuscitation Council (UK). Resuscitation. 2015 May;90:79-84. doi: 10.1016/j.resuscitation.2015.02.026. Epub 2015 Mar 9.
PubMed 25766092
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Video-based On-line Course vs. Serious Game for Training Medical Students in Cardiopulmonary Resuscitation: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03729037
- Acronym / sponsor ID
- 1818537
- Keywords
- Virtual learning, Educational technology, Medical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do SulUniversity, hospital or other
- Study start
- 10 Aug 2016 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 20 Aug 2017 (actual)
- First posted
- 2 Nov 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.
Participants were 45 first-year medical students randomly assigned to cardiopulmonary resuscitation (CPR) self-training using either a video-based presentation or a serious game developed in a 3D learning environment for up to 20 min. Each participant was evaluated on a written, multiple-choice test (theoretical test) and then on a scenario of cardiac arrest (practical test) before and after exposure to the self-learning methods.
Detailed description
A prospective, simulation-based, randomised controlled trial was conducted. Participants were randomised to the video group watched a video-recorded lecture on the management of adult cardiac arrest, while participants randomised to the game group played a serious game on the same topic.
The video was developed based on a previously recorded Keynote presentation (version 6.6.2, Apple Inc.) with the addition of voice-over narration of the events. The video was edited to contain the same information as provided in the serious game. The learning environment simulated an urban public space where the player should identify a victim of cardiac arrest and perform CPR manoeuvres. The game was designed to be a CPR self-learning tool for both health professionals and the lay public. The game involved only one rescuer without access to a portable defibrillator. During the game, the player should identify the victim, diagnose cardiac arrest correctly and initiate CPR as early as possible. The actions of the player were guided throughout the game by step-by-step instructions that should be followed to save the victim's life and to score on the game. Whenever the manoeuvres were not performed correctly, the victim died and the game automatically restarted from the beginning.
After exposure to the self-learning methods, participants were reassessed individually for their theoretical knowledge on a written, 10-question, multiple-choice test (theoretical post-test) and for their practical performance by three examiners, blinded to group assignment, who independently rated the participants' actions on a 10-min simulated scenario of cardiac arrest using a CPR training manikin (practical post-test).
Simulated scenario The same simulated scenario was used for pre-exposure and post-exposure practical evaluation. When the student entered the simulation room, a manikin was lying on the floor, simulating a person lying on the street, unconscious, not responding to stimulation and with no respiratory effort or pulse. The student was alone without access to medical equipment such as a defibrillator. Participants were expected to recognise the cardiac arrest, call the emergency services, and initiate chest compressions and ventilations as soon as possible for at least two cycles. A 10-min time limit was set for each simulation session.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serious game | Experimental | Other: CPR self-trainingIntervention: CPR self-training with serious game. |
| Training video | Active comparator | Other: CPR self-trainingIntervention: CPR self-training with Keynote presentation with the addition of voice-over narration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being a medical student;
- Voluntary participation;
- No previous participation in CPR training.
Key exclusion criteria (3 listed)
- Previous participation in CPR training.
- Refusal to participate.
- Not being enrolled in medical school.
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 |
|---|---|---|
| CPR self-training | Other | Serious game, Training video |
Primary outcome
American Heart Association (AHA) Guidelines for CPR
Time frame: 2 hours
Mean performance score of students on each (theoretical and practical) test for each study arm.
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 2 Nov 2018.
- Background: PubMed 26473002Bhanji F, Donoghue AJ, Wolff MS, Flores GE, Halamek LP, Berman JM, Sinz EH, Cheng A. Part 14: Education: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S561-73. doi: 10.1161/CIR.0000000000000268. No abstract available.
- Background: PubMed 25766092Thorne CJ, Lockey AS, Bullock I, Hampshire S, Begum-Ali S, Perkins GD; Advanced Life Support Subcommittee of the Resuscitation Council (UK). E-learning in advanced life support--an evaluation by the Resuscitation Council (UK). Resuscitation. 2015 May;90:79-84. doi: 10.1016/j.resuscitation.2015.02.026. Epub 2015 Mar 9.
- 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.
David P Sena, MD, PhD principal investigator
Pontificia Universidade Catolica do Rio Grande do Sul (PUCRS)
Questions about this trial
What is this clinical trial studying?
A study testing CPR self-training in people with Cardiopulmonary Arrest With Successful Resuscitation, run by Pontificia Universidade Católica do Rio Grande do Sul.
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 3 inclusion and 3 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 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
American Heart Association (AHA) Guidelines for CPR (time frame: 2 hours). 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 NCT03729037, which also lists 2 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 2 Nov 2018.