Cardiopulmonary ResuscitationTrainCPRNCT05493189
Assessment of CPR Skills Acquisition and Retention: Impact of Technology and Self-training
A study testing Additional autonomous training sessions in people with Cardiopulmonary Resuscitation, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Cardiopulmonary resuscitation (CPR) is an emergency maneuver used on a victim who is in cardiac arrest. Early and efficient CPR, with a focus on chest compressions, is a key element in increasing victim survival. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Resuscitation
- What is being tested?
- Additional autonomous training sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2023to 31 Dec 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (>= 18 years of age);
- Good state of health;
- Lack of formal training in CPR.
Who cannot join
- Pregnant women;
- Individuals with reduced mobility;
- Physical fatigue and/or reported muscle pain;
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Medicine (FMUP)
Porto, 4200-319
Abel Nicolau, MSc, PhDc, (+351) 220426836 ext. 26836, anicolau@med.up.pt
About this study
Cardiopulmonary resuscitation (CPR) is an emergency maneuver used on a victim who is in cardiac arrest. Early and efficient CPR, with a focus on chest compressions, is a key element in increasing victim survival. The success of resuscitation does not only depend on the immediate initiation of the maneuvers, but also on the quality with which they are applied. However, there is an obvious gap in the knowledge of these maneuvers. This study aims to analyze the acquisition and retention/maintenance of cardiopulmonary resuscitation (CPR) skills and the impact of the use of technology and autonomous training in medical students.
Read the detailed description
The objectives of this study include:
- Study the impact of using technology, namely simulators with automatic feedback, in CPR training.
- Study the potential of autonomous training as a complementary and/or alternative methodology in CPR training.
- Assess the acquisition and retention/maintenance of CPR skills, through autonomous and regular training.
The findings of this project are expected to promote awareness and behavioral change in the rescuer, leading to better outcomes for patients.
Experimental case-control study, aligned in two phases. In a first phase, all participants will be exposed to a period of autonomous training, with measurements of performance and quality of CPR, before and after training. This phase will allow investigating the acquisition of skills through autonomous training and leveling the skills of the entire sample. In a second phase, the sample will be randomly distributed between two groups and the retention/maintenance of skills will be evaluated over 1 year, considering that one of the groups will be exposed to 2 additional autonomous training sessions (after 2 and 6 months). The collection of technical skills data will be performed in the pre-training period, post-training (time zero) and after 2, 6 and 12 months - corresponding to 5 data collection moments, in both groups.
Both autonomous training and technical skills data collection will take place using a feedback CPR training simulator (eg Laerdal Little Anne QCPR). Along with the collection of technical skills data, theoretical knowledge will be assessed through a questionnaire. The duration of the autonomous training will be 30 minutes.
The sample will be recruited by convenience (non-probabilistic sample), using students of the 4th year of the Integrated Master in Medicine of the Faculty of Medicine of the University of Porto.
Data collection will take place at the Clinical Simulation Center of the Faculty of Medicine of the University of Porto (Portugal);
An estimate of the sample size was calculated considering the use of an ANOVA test for repeated measures. Using the G-Power software and considering an effect size of 0.20, significance level of 0.05, power of 0.95, for two groups and five measures, 96 participants will be needed. In this calculation, a null correlation coefficient was used, opting for a conservative approach to sample size calculation. Anticipating eventual dropouts, 150 participants will be recruited.
- Conditions
- Cardiopulmonary Resuscitation
- Being tested
- Additional autonomous training sessions
- Keywords
- Cardiopulmonary resuscitation, Chest compressions, Acquisition, Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional autonomous training sessionsOther
The duration of the autonomous training will be 30 minutes, using a feedback CPR training simulator (eg Laerdal Little Anne QCPR).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants with no additional autonomous training sessions. |
| Intervention Group | Experimental | Participants exposed to 2 additional autonomous training sessions (after 2 and 6 months). Receives: Other: Additional autonomous training sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CPR skills (acquisition)
Technical skills data collection will take place using a feedback CPR training simulator (eg Laerdal Little Anne QCPR). Along with the collection of technical skills data, theoretical knowledge will be assessed through a questionnaire. Both technical skills and theoretical knowledge will be aggregated to one general skills score.
Measured: Measurements of performance and quality of CPR (2 minutes of continuous chest compressions), immediately before and immediately after training, during the first phase (before randomization and group allocation).
Difference in CPR skills retention
Technical skills data collection will take place using a feedback CPR training simulator (eg Laerdal Little Anne QCPR). Along with the collection of technical skills data, theoretical knowledge will be assessed through a questionnaire. Both technical skills and theoretical knowledge will be aggregated to one general skills score.
Measured: Measurements of performance and quality of CPR (2 minutes of continuous chest compressions), in second phase at 2, 6 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Jan 2023
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary 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
- Model description
- Experimental case-control study, aligned in two phases.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde
- Responsible party
- Sponsor
- Investigators
- Carla Sa-Couto, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493189
- Sponsor's protocol ID
- TrainCPR
- Acronym
- TrainCPR
- Status last verified
- Oct 2023
- First submitted
- 1 Aug 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of CPR Skills Acquisition and Retention: Impact of Technology and Self-training
- ClinicalTrials.gov ID
- NCT05493189
- Acronym / sponsor ID
- TrainCPR / TrainCPR
- Conditions
- Cardiopulmonary Resuscitation
- Keywords
- Cardiopulmonary resuscitation, Chest compressions, Acquisition, Retention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Aug 2022 (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.
Cardiopulmonary resuscitation (CPR) is an emergency maneuver used on a victim who is in cardiac arrest. Early and efficient CPR, with a focus on chest compressions, is a key element in increasing victim survival. The success of resuscitation does not only depend on the immediate initiation of the maneuvers, but also on the quality with which they are applied. However, there is an obvious gap in the knowledge of these maneuvers. This study aims to analyze the acquisition and retention/maintenance of cardiopulmonary resuscitation (CPR) skills and the impact of the use of technology and autonomous training in medical students.
Detailed description
The objectives of this study include:
- Study the impact of using technology, namely simulators with automatic feedback, in CPR training.
- Study the potential of autonomous training as a complementary and/or alternative methodology in CPR training.
- Assess the acquisition and retention/maintenance of CPR skills, through autonomous and regular training.
The findings of this project are expected to promote awareness and behavioral change in the rescuer, leading to better outcomes for patients.
Experimental case-control study, aligned in two phases. In a first phase, all participants will be exposed to a period of autonomous training, with measurements of performance and quality of CPR, before and after training. This phase will allow investigating the acquisition of skills through autonomous training and leveling the skills of the entire sample. In a second phase, the sample will be randomly distributed between two groups and the retention/maintenance of skills will be evaluated over 1 year, considering that one of the groups will be exposed to 2 additional autonomous training sessions (after 2 and 6 months). The collection of technical skills data will be performed in the pre-training period, post-training (time zero) and after 2, 6 and 12 months - corresponding to 5 data collection moments, in both groups.
Both autonomous training and technical skills data collection will take place using a feedback CPR training simulator (eg Laerdal Little Anne QCPR). Along with the collection of technical skills data, theoretical knowledge will be assessed through a questionnaire. The duration of the autonomous training will be 30 minutes.
The sample will be recruited by convenience (non-probabilistic sample), using students of the 4th year of the Integrated Master in Medicine of the Faculty of Medicine of the University of Porto.
Data collection will take place at the Clinical Simulation Center of the Faculty of Medicine of the University of Porto (Portugal);
An estimate of the sample size was calculated considering the use of an ANOVA test for repeated measures. Using the G-Power software and considering an effect size of 0.20, significance level of 0.05, power of 0.95, for two groups and five measures, 96 participants will be needed. In this calculation, a null correlation coefficient was used, opting for a conservative approach to sample size calculation. Anticipating eventual dropouts, 150 participants will be recruited.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental case-control study, aligned in two phases.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants with no additional autonomous training sessions. |
| Intervention Group | Experimental | Other: Additional autonomous training sessionsParticipants exposed to 2 additional autonomous training sessions (after 2 and 6 months). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (>= 18 years of age);
- Good state of health;
- Lack of formal training in CPR.
Key exclusion criteria (3 listed)
- Pregnant women;
- Individuals with reduced mobility;
- Physical fatigue and/or reported muscle pain;
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 |
|---|---|---|
| Additional autonomous training sessionsThe duration of the autonomous training will be 30 minutes, using a feedback CPR training simulator (eg Laerdal Little Anne QCPR). | Other | Intervention Group |
Primary outcome
Change in CPR skills (acquisition)
Time frame: Measurements of performance and quality of CPR (2 minutes of continuous chest compressions), immediately before and immediately after training, during the first phase (before randomization and group allocation).
Technical skills data collection will take place using a feedback CPR training simulator (eg Laerdal Little Anne QCPR). Along with the collection of technical skills data, theoretical knowledge will be assessed through a questionnaire. Both technical skills and theoretical knowledge will be aggregated to one general skills score.
Difference in CPR skills retention
Time frame: Measurements of performance and quality of CPR (2 minutes of continuous chest compressions), in second phase at 2, 6 and 12 months.
Technical skills data collection will take place using a feedback CPR training simulator (eg Laerdal Little Anne QCPR). Along with the collection of technical skills data, theoretical knowledge will be assessed through a questionnaire. Both technical skills and theoretical knowledge will be aggregated to one general skills score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Carla Sa-Couto, PhD principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional autonomous training sessions in people with Cardiopulmonary Resuscitation, run by Universidade do Porto at 1 site in Portugal.
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: status not confirmed, as of the sponsor's last update on 19 Oct 2023. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abel Nicolau, MSc, PhDc ((+351) 220426836 ext. 26836, anicolau@med.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CPR skills (acquisition) (time frame: Measurements of performance and quality of CPR (2 minutes of continuous chest compressions), immediately before and immediately after training, during the first phase (before randomization and group allocation).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.