Cardiopulmonary Arrest With Successful ResuscitationNCT04440111
Basic Life Support by Children
A study testing One year training and Two years training in people with Cardiopulmonary Arrest With Successful Resuscitation and Child, Only, run by Cristina Genzor at 1 site in Spain.
Trial summary
A controlled clinical trial will be performed. School children from the age of 10 to 11 will be selected to learn basic life support (BLS) in a primary school of Zaragoza. One of the groups will learn BLS in two consecutive years and the other group will learn BLS only the first year. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Arrest With Successful Resuscitation, Child, Only
- What is being tested?
- One year training and Two years training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 11 Feb 2020to Apr 2021
- 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 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children from 10 to 12 years old that are attending to the selected school at the moment of the intervention
- Children with signed consent given by parents at the moment of the intervention
Who cannot join
- Children not attending all the theorical and practical interventions
- Children not completing all test.
- Children with learning disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Teaching Children Basic Life Support: Randomized Clinical Trial
A controlled clinical trial will be performed.
School children from the age of 10 to 11 will be selected to learn basic life support (BLS) in a primary school of Zaragoza.
One of the groups will learn BLS in two consecutive years and the other group will learn BLS only the first year.
The investigators think that the knowledge will be better in the group that receives two interventions.
Read the detailed description
A controlled clinical trial will be performed.
72 participants between 10 and 11 years old will be selected and randomized to participate.
Control group and experimental group will enrolled 36 participants each one. Control group will receive BLS training once. Experimental group will receive BLS training in two consecutive years.
Previous and after training a test will be performed.
- Being tested
- One year training, Two years training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One year trainingOther
Also called One year basic life support training
At first, children will make a test to evaluate their pre- intervention basic support life knowledge.
Secondly, they will receive a theoretical class about BLS, based on European Resuscitation Council Guide 2015.
After that, they will make a practical workshop on BLS. Finally they will repeat the initial test. The second year, this group will only make the test, they won't receive any theory or practice.
Two years trainingOther
Also called Two years basic life support training
At first, children will make a test to evaluate their pre- intervention basic support life knowledge.
Secondly, they will receive a theoretical class about BLS, based on European Resuscitation Council Guide 2015. After that they will make a practical workshop on BLS.
Finally they will repeat the initial test. The second year, this group will repeat the same process.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | One year basic life support training Receives: Other: One year training |
| Experimental group | Sham comparator | Two years basic life support training Receives: Other: Two years training |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the knowledge level of BLS after receiving one or two interventions
A questionnaire will be performed. It will consist of a 14 multiple-choice questions. Each question will have 4 choices, one of wich will be correct. Questions will be based on the European Resuscitation Council (ERC) Guidelines 2015.
Measured: 3 hours
To compare test results obtained previous and after intervention.
A questionnaire will be performed. It will consist of a 14 multiple-choice questions. Each question will have 4 choices, one of wich will be correct. Questions will be based on the European Resuscitation Council (ERC) Guidelines 2015. After obteining the marks, the results will be compared using Statistical Analysis Software.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start11 Feb 2020
- Primary completion27 Feb 2020
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristina Genzor
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Miguel Servet
- Responsible party
- Sponsor-investigator, Cristina Genzor, Instituto de Investigación Sanitaria Aragón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440111
- Sponsor's protocol ID
- PI19/490
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Semeraro F, Wingen S, Schroeder DC, Ecker H, Scapigliati A, Ristagno G, Cimpoesu D, Bottiger BW. KIDS SAVE LIVES-Three years of implementation in Europe. Resuscitation. 2018 Oct;131:e9-e11. doi: 10.1016/j.resuscitation.2018.08.008. Epub 2018 Aug 8. No abstract available.
PubMed 30098386Bottiger BW, Van Aken H. Kids save lives--Training school children in cardiopulmonary resuscitation worldwide is now endorsed by the World Health Organization (WHO). Resuscitation. 2015 Sep;94:A5-7. doi: 10.1016/j.resuscitation.2015.07.005. Epub 2015 Jul 21. No abstract available.
PubMed 26209417Bohn A, Van Aken HK, Mollhoff T, Wienzek H, Kimmeyer P, Wild E, Dopker S, Lukas RP, Weber TP. Teaching resuscitation in schools: annual tuition by trained teachers is effective starting at age 10. A four-year prospective cohort study. Resuscitation. 2012 May;83(5):619-25. doi: 10.1016/j.resuscitation.2012.01.020. Epub 2012 Jan 28.
PubMed 22286049Lukas RP, Van Aken H, Molhoff T, Weber T, Rammert M, Wild E, Bohn A. Kids save lives: a six-year longitudinal study of schoolchildren learning cardiopulmonary resuscitation: Who should do the teaching and will the effects last? Resuscitation. 2016 Apr;101:35-40. doi: 10.1016/j.resuscitation.2016.01.028. Epub 2016 Feb 8.
PubMed 26868079Bohn A, Lukas RP, Breckwoldt J, Bottiger BW, Van Aken H. 'Kids save lives': why schoolchildren should train in cardiopulmonary resuscitation. Curr Opin Crit Care. 2015 Jun;21(3):220-5. doi: 10.1097/MCC.0000000000000204.
PubMed 25922895Haseneder R, Skrzypczak M, Haller B, Beckers SK, Holch J, Wank C, Kochs E, Schulz CM. Impact of instructor professional background and interim retesting on knowledge and self-confidence of schoolchildren after basic life support training: a cluster randomised longitudinal study. Emerg Med J. 2019 Apr;36(4):239-244. doi: 10.1136/emermed-2018-207923. Epub 2019 Feb 16.
PubMed 30772830
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching Children Basic Life Support: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04440111
- Acronym / sponsor ID
- PI19/490
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cristina GenzorUniversity, hospital or other
- Collaborators
- Hospital Miguel Servet
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- Apr 2021 (estimated)
- First posted
- 19 Jun 2020 (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.
A controlled clinical trial will be performed.
School children from the age of 10 to 11 will be selected to learn basic life support (BLS) in a primary school of Zaragoza.
One of the groups will learn BLS in two consecutive years and the other group will learn BLS only the first year.
The investigators think that the knowledge will be better in the group that receives two interventions.
Detailed description
A controlled clinical trial will be performed.
72 participants between 10 and 11 years old will be selected and randomized to participate.
Control group and experimental group will enrolled 36 participants each one. Control group will receive BLS training once. Experimental group will receive BLS training in two consecutive years.
Previous and after training a test will be performed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: One year trainingOne year basic life support training |
| Experimental group | Sham comparator | Other: Two years trainingTwo years basic life support training |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children from 10 to 12 years old that are attending to the selected school at the moment of the intervention
- Children with signed consent given by parents at the moment of the intervention
Key exclusion criteria (3 listed)
- Children not attending all the theorical and practical interventions
- Children not completing all test.
- Children with learning disabilities
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 |
|---|---|---|
| One year trainingAlso: One year basic life support trainingAt first, children will make a test to evaluate their pre- intervention basic support life knowledge. Secondly, they will receive a theoretical class about BLS, based on European Resuscitation Council Guide 2015. After that, they will make a practical workshop on BLS. Finally they will repeat the initial test. The second year, this group will only make the test, they won't receive any theory or practice. | Other | Control group |
| Two years trainingAlso: Two years basic life support trainingAt first, children will make a test to evaluate their pre- intervention basic support life knowledge. Secondly, they will receive a theoretical class about BLS, based on European Resuscitation Council Guide 2015. After that they will make a practical workshop on BLS. Finally they will repeat the initial test. The second year, this group will repeat the same process. | Other | Experimental group |
Primary outcome
To evaluate the knowledge level of BLS after receiving one or two interventions
Time frame: 3 hours
A questionnaire will be performed. It will consist of a 14 multiple-choice questions. Each question will have 4 choices, one of wich will be correct. Questions will be based on the European Resuscitation Council (ERC) Guidelines 2015.
To compare test results obtained previous and after intervention.
Time frame: 1 month
A questionnaire will be performed. It will consist of a 14 multiple-choice questions. Each question will have 4 choices, one of wich will be correct. Questions will be based on the European Resuscitation Council (ERC) Guidelines 2015. After obteining the marks, the results will be compared using Statistical Analysis Software.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Results publication: PubMed 30098386Semeraro F, Wingen S, Schroeder DC, Ecker H, Scapigliati A, Ristagno G, Cimpoesu D, Bottiger BW. KIDS SAVE LIVES-Three years of implementation in Europe. Resuscitation. 2018 Oct;131:e9-e11. doi: 10.1016/j.resuscitation.2018.08.008. Epub 2018 Aug 8. No abstract available.
- Results publication: PubMed 26209417Bottiger BW, Van Aken H. Kids save lives--Training school children in cardiopulmonary resuscitation worldwide is now endorsed by the World Health Organization (WHO). Resuscitation. 2015 Sep;94:A5-7. doi: 10.1016/j.resuscitation.2015.07.005. Epub 2015 Jul 21. No abstract available.
- Results publication: PubMed 22286049Bohn A, Van Aken HK, Mollhoff T, Wienzek H, Kimmeyer P, Wild E, Dopker S, Lukas RP, Weber TP. Teaching resuscitation in schools: annual tuition by trained teachers is effective starting at age 10. A four-year prospective cohort study. Resuscitation. 2012 May;83(5):619-25. doi: 10.1016/j.resuscitation.2012.01.020. Epub 2012 Jan 28.
- Results publication: PubMed 26868079Lukas RP, Van Aken H, Molhoff T, Weber T, Rammert M, Wild E, Bohn A. Kids save lives: a six-year longitudinal study of schoolchildren learning cardiopulmonary resuscitation: Who should do the teaching and will the effects last? Resuscitation. 2016 Apr;101:35-40. doi: 10.1016/j.resuscitation.2016.01.028. Epub 2016 Feb 8.
- Results publication: PubMed 25922895Bohn A, Lukas RP, Breckwoldt J, Bottiger BW, Van Aken H. 'Kids save lives': why schoolchildren should train in cardiopulmonary resuscitation. Curr Opin Crit Care. 2015 Jun;21(3):220-5. doi: 10.1097/MCC.0000000000000204.
- Results publication: PubMed 30772830Haseneder R, Skrzypczak M, Haller B, Beckers SK, Holch J, Wank C, Kochs E, Schulz CM. Impact of instructor professional background and interim retesting on knowledge and self-confidence of schoolchildren after basic life support training: a cluster randomised longitudinal study. Emerg Med J. 2019 Apr;36(4):239-244. doi: 10.1136/emermed-2018-207923. Epub 2019 Feb 16.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One year training and Two years training in people with Cardiopulmonary Arrest With Successful Resuscitation and Child, Only, run by Cristina Genzor at 1 site in Spain.
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 2 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 Jun 2020. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
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?
To evaluate the knowledge level of BLS after receiving one or two interventions (time frame: 3 hours). 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?
On the ClinicalTrials.gov record for NCT04440111, which also lists 6 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 19 Jun 2020.