Cardiopulmonary ResuscitationBLSGimiHunNCT06016153
The Efficacy of Basic Life Support Education Among Teenagers
A study testing Software based feedback and Instructor feedback in people with Cardiopulmonary Resuscitation and Basic Life Support, run by Semmelweis University at 1 site in Hungary.
Trial summary
Basic life support (BLS) skills are crucial not only for healthcare workers but for all lay people as well. Timely recognition of out-of-hospital cardiac arrest and the initiation of BLS by bystanders before the arrival of healthcare personnel can improve survival. Read more about this study
- Who is it for?
- Ages 16 to 19 years
- Conditions the study is for
- Cardiopulmonary Resuscitation, Basic Life Support, Premedical Education
- What is being tested?
- Software based feedback and Instructor feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteHungary
- Study dates
- 1 Dec 2023to 31 Jul 2024
- 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 16 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- High school teenagers participating in the education of Óbudai High School, Budapest
- Written informed consent received from participants and their parents to participate in the study
Who cannot join
- No written informed consent provided by the student or parent
- Any injury or health issue influencing the efficacy of BLS skill
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Investigation of the Efficacy of Basic Life Support Education Among High School Students
Basic life support (BLS) skills are crucial not only for healthcare workers but for all lay people as well. Timely recognition of out-of-hospital cardiac arrest and the initiation of BLS by bystanders before the arrival of healthcare personnel can improve survival.
There are several methods of spreading BLS skills and improve BLS skill retention among lay people. One of these methods can be educating school children. The introduction of mandatory BLS education in schools was very effective in some European countries to increase the rate of bystander BLS.
The current study aims to investigate the efficacy of a BLS training and BLS curriculum among high school children in Hungary. Moreover, the investigators would like to optimise factors influencing skill retention in this first responder group and aim to compare two types of teaching methods: feedback given by the instructor or software-based feedback on the efficacy of chest compressions during the course.
- Being tested
- Software based feedback, Instructor feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Software based feedbackOther
Feedback is given by the data of a software (InnoMed CardioAid-1 Trainer AED, Innomed Inc., Budapest, Hungary).
Instructor feedbackOther
Feedback is given by the opinion and observation of an experienced instructor.
| Study group | Role | What they receive |
|---|---|---|
| Instructor feedback | Active comparator | BLS training participants will receive feedback from an experienced instructor certified by European Resuscitation Council on the depth and frequency of chest compressions, duty cycle, chest recoil and the quality of ventilation. Receives: Other: Instructor feedback |
| Software feedback | Experimental | BLS training participants will receive feedback based on a software (InnoMed CardioAid-1 Trainer AED, Innomed Inc., Budapest, Hungary) on the quality of chest compression (exact frequency, depth of chest compression, chest recoil and duty cycle) and tidal volume during ventilation. Receives: Other: Software based feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
End of training BLS skill assessment based on a checklist
BLS skills measured right after the training based on a checklist including the most important steps of BLS and quality of chest compression. The assessment will be performed by two instructors and the software of InnoMed CardioAid-1 Trainer AED, Innomed Inc., Budapest, Hungary.
Measured: up to two hours
Secondary outcomes (2)
BLS skill assessment after 2 months based on a checklist
BLS skills measured 2 months after the training based on a checklist including the most important steps of BLS and quality of chest compression. The assessment will be performed by two instructors and the software of InnoMed CardioAid-1 Trainer AED, Innomed Inc., Budapest, Hungary.
Measured: 2 months
BLS skill assessment after 6 months based on a checklist
BLS skills measured 6 months after the training based on a checklist including the most important steps of BLS and quality of chest compression. The assessment will be performed by two instructors and the software of InnoMed CardioAid-1 Trainer AED, Innomed Inc., Budapest, Hungary.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Dec 2023
- Primary completion29 Feb 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ResuscitationStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- 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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Endre Zima, PhD, Principal investigator, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016153
- Sponsor's protocol ID
- SUVM_BLS_1
- Acronym
- BLSGimiHun
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maar C, Zima E, Nagy B, Pal-Jakab A, Szvath P, Kiss B, Frituz G, Gal J, Merkely B, Kovacs E. The investigation of the efficiency of basic life support education among high school students: Protocol, design and implementation of an interventional, prospective longitudinal, individually randomised, parallel 1:1 grouped trial. Resusc Plus. 2024 Feb 28;18:100585. doi: 10.1016/j.resplu.2024.100585. eCollection 2024 Jun.
PubMed 38439933
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of the Efficacy of Basic Life Support Education Among High School Students
- ClinicalTrials.gov ID
- NCT06016153
- Acronym / sponsor ID
- BLSGimiHun / SUVM_BLS_1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 29 Aug 2023 (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.
Basic life support (BLS) skills are crucial not only for healthcare workers but for all lay people as well. Timely recognition of out-of-hospital cardiac arrest and the initiation of BLS by bystanders before the arrival of healthcare personnel can improve survival.
There are several methods of spreading BLS skills and improve BLS skill retention among lay people. One of these methods can be educating school children. The introduction of mandatory BLS education in schools was very effective in some European countries to increase the rate of bystander BLS.
The current study aims to investigate the efficacy of a BLS training and BLS curriculum among high school children in Hungary. Moreover, the investigators would like to optimise factors influencing skill retention in this first responder group and aim to compare two types of teaching methods: feedback given by the instructor or software-based feedback on the efficacy of chest compressions during the course.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instructor feedback | Active comparator | Other: Instructor feedbackBLS training participants will receive feedback from an experienced instructor certified by European Resuscitation Council on the depth and frequency of chest compressions, duty cycle, chest recoil and the quality of ventilation. |
| Software feedback | Experimental | Other: Software based feedbackBLS training participants will receive feedback based on a software (InnoMed CardioAid-1 Trainer AED, Innomed Inc., Budapest, Hungary) on the quality of chest compression (exact frequency, depth of chest compression, chest recoil and duty cycle) and tidal volume during ventilation. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- High school teenagers participating in the education of Óbudai High School, Budapest
- Written informed consent received from participants and their parents to participate in the study
Key exclusion criteria (2 listed)
- No written informed consent provided by the student or parent
- Any injury or health issue influencing the efficacy of BLS skill
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 |
|---|---|---|
| Software based feedbackFeedback is given by the data of a software (InnoMed CardioAid-1 Trainer AED, Innomed Inc., Budapest, Hungary). | Other | Software feedback |
| Instructor feedbackFeedback is given by the opinion and observation of an experienced instructor. | Other | Instructor feedback |
Primary outcome
End of training BLS skill assessment based on a checklist
Time frame: up to two hours
BLS skills measured right after the training based on a checklist including the most important steps of BLS and quality of chest compression. The assessment will be performed by two instructors and the software of InnoMed CardioAid-1 Trainer AED, Innomed Inc., Budapest, Hungary.
2 secondary outcomes
BLS skill assessment after 2 months based on a checklist
Time frame: 2 months
BLS skill assessment after 6 months based on a checklist
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Derived from this study: PubMed 38439933Maar C, Zima E, Nagy B, Pal-Jakab A, Szvath P, Kiss B, Frituz G, Gal J, Merkely B, Kovacs E. The investigation of the efficiency of basic life support education among high school students: Protocol, design and implementation of an interventional, prospective longitudinal, individually randomised, parallel 1:1 grouped trial. Resusc Plus. 2024 Feb 28;18:100585. doi: 10.1016/j.resplu.2024.100585. eCollection 2024 Jun.
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Cardiac Arrest, Out-Of-Hospital, Hypotension
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.
Endre Zima, PhD principal investigator
Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Software based feedback and Instructor feedback in people with Cardiopulmonary Resuscitation and Basic Life Support, run by Semmelweis University at 1 site in Hungary.
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 2 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 9 Feb 2024. 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 Hungary. 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 Uzonka Szabolcsi (+361458680, szabolcsiu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End of training BLS skill assessment based on a checklist (time frame: up to two 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 NCT06016153, which also lists 1 linked publication.
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 9 Feb 2024.