Cardiopulmonary ResuscitationNCT05023616
Evaluation of Efficacy of Online Real-time Home CPR Training Program
A study testing Real-time home CPR training and Conventional CPR training in people with Cardiopulmonary Resuscitation and Cardiopulmonary Arrest, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effectiveness of a real-time home CPR(cardiopulmonary resuscitation) training program. The study participants will be allocated to two different CPR training programs. 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, Cardiopulmonary Arrest, Education
- What is being tested?
- Real-time home CPR training and Conventional CPR training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Aug 2021to 31 Aug 2022
- 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 without prior CPR training within 6 months
Who cannot join
- Healthcare providers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy of Online Real-time Home CPR Training Program : a Randomized Open-label Clinical Trial
The purpose of this study is to evaluate the effectiveness of a real-time home CPR(cardiopulmonary resuscitation) training program. The study participants will be allocated to two different CPR training programs. The intervention group will participate in the real-time home CPR training program while the control group will participate in the conventional CPR training program. The investigators will compare the quality of chest compression between the two study groups. The investigators hypothesize that the new real-time home CPR training program is non-inferior to the preexisting conventional CPR training program.
Read the detailed description
Bystander CPR(cardiopulmonary resuscitation) is important for the survival of out-of-hospital cardiac arrest patients. CPR training for the general public is important to improve the rate and quality of bystander CPR. Conventional CPR education was conducted under face-to-face contact with instructors and multiple trainees gathered at a training center, but after the coronavirus disease 2019 pandemic, face-to-face training became difficult. To overcome this limitation the investigators have developed a new real-time home CPR training program. The training program delivers Little Anne QCPR mannequins (Laerdal, Stavanger, Norway) to each participants homes and the participants use an application specifically developed for CPR training that automatically connects wirelessly to the Little Anne QCPR mannequin through Bluetooth so that the instructor can give real-time feedback on chest compression quality to participants.
The purpose of this study is to evaluate the effectiveness of a real-time home CPR(cardiopulmonary resuscitation) training program. The study participants will be allocated to two different CPR training programs. The intervention group will participate in the real-time home CPR training program while the control group will participate in the conventional CPR training program. The investigators will compare the quality of chest compression between the two study groups. Chest compression quality at the start of both training programs and after completion of the programs will be measured by Little Anne QCPR mannequins used in the training programs. The investigators hypothesize that the new real-time home CPR training program is non-inferior to the preexisting conventional CPR training program.
- Being tested
- Real-time home CPR training, Conventional CPR training
- Keywords
- Cardiopulmonary Resuscitation, Education
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time home CPR trainingOther
The participants in the intervention group will have Little Anne QCPR mannequins (Laerdal, Stavanger, Norway) delivered to their homes. The participants will use an online platform specifically developed for CPR training (HEROS Remote app). The training program will provide video-based self-instruction training followed by hands-on chest compression training with the instructor. The hands-on chest compression training session provides real-time chest compression quality measurement followed by real-time feedback from the instructor. Chest compression quality will be measured by Little Anne QCPR mannequins.
Conventional CPR trainingOther
Participants in the conventional CPR training program group will be provided CPR education with the "Home Education and Resuscitation Outcome Study (HEROS)" program that is currently provided in Seoul, Korea. The HEROS program is a 1-hour training course, consisting of a 30-minute video-based self-instruction training with a mannequin. The program also includes a bystander CPR simulation with a simulated dispatcher using the participants own cell phone. Little Anne QCPR mannequins will be provided to measure and give feedback on the participants chest compression performance.
| Study group | Role | What they receive |
|---|---|---|
| Real-time home CPR training | Experimental | Online real-time home CPR(cardiopulmonary resuscitation) training will be provided to participants Receives: Other: Real-time home CPR training |
| Conventional CPR training | Active comparator | Conventional CPR training will be provided to participants Receives: Other: Conventional CPR training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average compression depth
Average compression depth of chest compression performed for 2 minutes
Measured: Immediately after the training program has been completed, participants will be asked to perform chest compression for 2 minutes. The outcome measure will be collected from the 2 minutes of chest compression at this point.
Secondary outcomes (4)
Proportion of adequate compression depth
Proportion of adequate compression depth performed for 2 minutes
Measured: Immediately after the training program has been completed, participants will be asked to perform chest compression for 2 minutes. The outcome measure will be collected from the 2 minutes of chest compression at this point.
Average compression rate
Average compression rate of chest compression performed for 2 minutes
Measured: Immediately after the training program has been completed, participants will be asked to perform chest compression for 2 minutes. The outcome measure will be collected from the 2 minutes of chest compression at this point.
Proportion of adequate compression rate
Proportion of adequate compression rate performed for 2 minutes
Measured: Immediately after the training program has been completed, participants will be asked to perform chest compression for 2 minutes. The outcome measure will be collected from the 2 minutes of chest compression at this point.
No-flow fraction
Proportion of no-flow time during 2 minutes of chest compression
Measured: Immediately after the training program has been completed, participants will be asked to perform chest compression for 2 minutes. The outcome measure will be collected from the 2 minutes of chest compression at this point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start26 Aug 2021
- Primary completion31 Dec 2021
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 Seoul National University HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Jeong Hong, Seoul National University Hospital
- Investigators
- Ki Jeong Hong, MD, Study chair, Department of Emergency Medicine, Seoul National University HospitalSTEPHEN GW LEE, MD, Principal investigator, Department of Emergency Medicine, SMG-SNU Boramae Medical CenterSeulki Choi, MD, Principal investigator, Department of Emergency Medicine, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023616
- Sponsor's protocol ID
- H-2107-205-1239
- Status last verified
- Oct 2022
- First submitted
- 6 Aug 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Panchal AR, Bartos JA, Cabanas JG, Donnino MW, Drennan IR, Hirsch KG, Kudenchuk PJ, Kurz MC, Lavonas EJ, Morley PT, O'Neil BJ, Peberdy MA, Rittenberger JC, Rodriguez AJ, Sawyer KN, Berg KM; Adult Basic and Advanced Life Support Writing Group. Part 3: Adult Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S366-S468. doi: 10.1161/CIR.0000000000000916. Epub 2020 Oct 21. No abstract available.
PubMed 33081529Nolan JP, Monsieurs KG, Bossaert L, Bottiger BW, Greif R, Lott C, Madar J, Olasveengen TM, Roehr CC, Semeraro F, Soar J, Van de Voorde P, Zideman DA, Perkins GD; European Resuscitation Council COVID-Guideline Writing Groups. European Resuscitation Council COVID-19 guidelines executive summary. Resuscitation. 2020 Aug;153:45-55. doi: 10.1016/j.resuscitation.2020.06.001. Epub 2020 Jun 7.
PubMed 32525022Cheng A, Magid DJ, Auerbach M, Bhanji F, Bigham BL, Blewer AL, Dainty KN, Diederich E, Lin Y, Leary M, Mahgoub M, Mancini ME, Navarro K, Donoghue A. Part 6: Resuscitation Education Science: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S551-S579. doi: 10.1161/CIR.0000000000000903. Epub 2020 Oct 21. No abstract available.
PubMed 33081527Nas J, Thannhauser J, Vart P, van Geuns RJ, Muijsers HEC, Mol JQ, Aarts GWA, Konijnenberg LSF, Gommans DHF, Ahoud-Schoenmakers SGAM, Vos JL, van Royen N, Bonnes JL, Brouwer MA. Effect of Face-to-Face vs Virtual Reality Training on Cardiopulmonary Resuscitation Quality: A Randomized Clinical Trial. JAMA Cardiol. 2020 Mar 1;5(3):328-335. doi: 10.1001/jamacardio.2019.4992.
PubMed 31734702Park GJ, Kong SYJ, Song KJ, Shin SD, Kim TH, Ro YS, Myklebust H, Birkenes TS. The Effectiveness of a New Dispatcher-Assisted Basic Life Support Training Program on Quality in Cardiopulmonary Resuscitation Performance During Training and Willingness to Perform Bystander Cardiopulmonary Resuscitation: A Cluster Randomized Controlled Study. Simul Healthc. 2020 Oct;15(5):318-325. doi: 10.1097/SIH.0000000000000435.
PubMed 32604135
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Online Real-time Home CPR Training Program : a Randomized Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT05023616
- Acronym / sponsor ID
- H-2107-205-1239
- Keywords
- Cardiopulmonary Resuscitation, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 26 Aug 2021 (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.
The purpose of this study is to evaluate the effectiveness of a real-time home CPR(cardiopulmonary resuscitation) training program. The study participants will be allocated to two different CPR training programs. The intervention group will participate in the real-time home CPR training program while the control group will participate in the conventional CPR training program. The investigators will compare the quality of chest compression between the two study groups. The investigators hypothesize that the new real-time home CPR training program is non-inferior to the preexisting conventional CPR training program.
Detailed description
Bystander CPR(cardiopulmonary resuscitation) is important for the survival of out-of-hospital cardiac arrest patients. CPR training for the general public is important to improve the rate and quality of bystander CPR. Conventional CPR education was conducted under face-to-face contact with instructors and multiple trainees gathered at a training center, but after the coronavirus disease 2019 pandemic, face-to-face training became difficult. To overcome this limitation the investigators have developed a new real-time home CPR training program. The training program delivers Little Anne QCPR mannequins (Laerdal, Stavanger, Norway) to each participants homes and the participants use an application specifically developed for CPR training that automatically connects wirelessly to the Little Anne QCPR mannequin through Bluetooth so that the instructor can give real-time feedback on chest compression quality to participants.
The purpose of this study is to evaluate the effectiveness of a real-time home CPR(cardiopulmonary resuscitation) training program. The study participants will be allocated to two different CPR training programs. The intervention group will participate in the real-time home CPR training program while the control group will participate in the conventional CPR training program. The investigators will compare the quality of chest compression between the two study groups. Chest compression quality at the start of both training programs and after completion of the programs will be measured by Little Anne QCPR mannequins used in the training programs. The investigators hypothesize that the new real-time home CPR training program is non-inferior to the preexisting conventional CPR training program.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-time home CPR training | Experimental | Other: Real-time home CPR trainingOnline real-time home CPR(cardiopulmonary resuscitation) training will be provided to participants |
| Conventional CPR training | Active comparator | Other: Conventional CPR trainingConventional CPR training will be provided to participants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults without prior CPR training within 6 months
Key exclusion criteria (1 listed)
- Healthcare providers
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 |
|---|---|---|
| Real-time home CPR trainingThe participants in the intervention group will have Little Anne QCPR mannequins (Laerdal, Stavanger, Norway) delivered to their homes. The participants will use an online platform specifically developed for CPR training (HEROS Remote app). The training program will provide video-based self-instruction training followed by hands-on chest compression training with the instructor. The hands-on chest compression training session provides real-time chest compression quality measurement followed by real-time feedback from the instructor. Chest compression quality will be measured by Little Anne QCPR mannequins. | Other | Real-time home CPR training |
| Conventional CPR trainingParticipants in the conventional CPR training program group will be provided CPR education with the "Home Education and Resuscitation Outcome Study (HEROS)" program that is currently provided in Seoul, Korea. The HEROS program is a 1-hour training course, consisting of a 30-minute video-based self-instruction training with a mannequin. The program also includes a bystander CPR simulation with a simulated dispatcher using the participants own cell phone. Little Anne QCPR mannequins will be provided to measure and give feedback on the participants chest compression performance. | Other | Conventional CPR training |
Primary outcome
Average compression depth
Time frame: Immediately after the training program has been completed, participants will be asked to perform chest compression for 2 minutes. The outcome measure will be collected from the 2 minutes of chest compression at this point.
Average compression depth of chest compression performed for 2 minutes
4 secondary outcomes
Proportion of adequate compression depth
Time frame: Immediately after the training program has been completed, participants will be asked to perform chest compression for 2 minutes. The outcome measure will be collected from the 2 minutes of chest compression at this point.
Average compression rate
Time frame: Immediately after the training program has been completed, participants will be asked to perform chest compression for 2 minutes. The outcome measure will be collected from the 2 minutes of chest compression at this point.
Proportion of adequate compression rate
Time frame: Immediately after the training program has been completed, participants will be asked to perform chest compression for 2 minutes. The outcome measure will be collected from the 2 minutes of chest compression at this point.
No-flow fraction
Time frame: Immediately after the training program has been completed, participants will be asked to perform chest compression for 2 minutes. The outcome measure will be collected from the 2 minutes of chest compression at this point.
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 27 Oct 2022.
- Background: PubMed 33081529Panchal AR, Bartos JA, Cabanas JG, Donnino MW, Drennan IR, Hirsch KG, Kudenchuk PJ, Kurz MC, Lavonas EJ, Morley PT, O'Neil BJ, Peberdy MA, Rittenberger JC, Rodriguez AJ, Sawyer KN, Berg KM; Adult Basic and Advanced Life Support Writing Group. Part 3: Adult Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S366-S468. doi: 10.1161/CIR.0000000000000916. Epub 2020 Oct 21. No abstract available.
- Background: PubMed 32525022Nolan JP, Monsieurs KG, Bossaert L, Bottiger BW, Greif R, Lott C, Madar J, Olasveengen TM, Roehr CC, Semeraro F, Soar J, Van de Voorde P, Zideman DA, Perkins GD; European Resuscitation Council COVID-Guideline Writing Groups. European Resuscitation Council COVID-19 guidelines executive summary. Resuscitation. 2020 Aug;153:45-55. doi: 10.1016/j.resuscitation.2020.06.001. Epub 2020 Jun 7.
- Background: PubMed 33081527Cheng A, Magid DJ, Auerbach M, Bhanji F, Bigham BL, Blewer AL, Dainty KN, Diederich E, Lin Y, Leary M, Mahgoub M, Mancini ME, Navarro K, Donoghue A. Part 6: Resuscitation Education Science: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S551-S579. doi: 10.1161/CIR.0000000000000903. Epub 2020 Oct 21. No abstract available.
- Background: PubMed 31734702Nas J, Thannhauser J, Vart P, van Geuns RJ, Muijsers HEC, Mol JQ, Aarts GWA, Konijnenberg LSF, Gommans DHF, Ahoud-Schoenmakers SGAM, Vos JL, van Royen N, Bonnes JL, Brouwer MA. Effect of Face-to-Face vs Virtual Reality Training on Cardiopulmonary Resuscitation Quality: A Randomized Clinical Trial. JAMA Cardiol. 2020 Mar 1;5(3):328-335. doi: 10.1001/jamacardio.2019.4992.
- Background: PubMed 32604135Park GJ, Kong SYJ, Song KJ, Shin SD, Kim TH, Ro YS, Myklebust H, Birkenes TS. The Effectiveness of a New Dispatcher-Assisted Basic Life Support Training Program on Quality in Cardiopulmonary Resuscitation Performance During Training and Willingness to Perform Bystander Cardiopulmonary Resuscitation: A Cluster Randomized Controlled Study. Simul Healthc. 2020 Oct;15(5):318-325. doi: 10.1097/SIH.0000000000000435.
- 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.
Ki Jeong Hong, MD study chair
Department of Emergency Medicine, Seoul National University Hospital
STEPHEN GW LEE, MD principal investigator
Department of Emergency Medicine, SMG-SNU Boramae Medical Center
Seulki Choi, MD principal investigator
Department of Emergency Medicine, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time home CPR training and Conventional CPR training in people with Cardiopulmonary Resuscitation and Cardiopulmonary Arrest, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 1 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 27 Oct 2022. 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 South Korea. 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?
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?
Average compression depth (time frame: Immediately after the training program has been completed, participants will be asked to perform chest compression for 2 minutes. The outcome measure will be collected from the 2 minutes of chest compression at this point.). 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 NCT05023616, which also lists 5 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 27 Oct 2022.