Cardiopulmonary ResuscitationNCT04656405
Efficacy of Online Real-time CPR Training
A study testing Online real-time quality measurement and feedback video-based CPR training, Online real-time feedback video-based CPR training without quality measurement and Conventional CPR training in people with Cardiopulmonary Resuscitation and Education, 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 new online real-time quality measurement and feedback video-based CPR training program. The study participants will be allocated to three different CPR training programs: online real-time quality measurement and feedback video-based CPR training program… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Resuscitation, Education
- What is being tested?
- Online real-time quality measurement and feedback video-based CPR training, Online real-time feedback video-based CPR training without quality measurement and Conventional CPR training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Dec 2020to 31 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers aged 18 years or older
Who cannot join
- Healthcare providers
- Participants with chronic lung diseases
- Participants with cardiovascular diseases
- Participants with visual disabilities
- Participants with hearing disabilities
- Participants with musculoskeletal disabilities
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul Metropolitan Government-Seoul National University Borame Medical Center
Seoul, 07061
STEPHEN GW LEE, MD, 82)-10-5124-8415, LEESTEPHENGYUNGWON@GMAIL.COM
About this study
Official title: Evaluation of Efficacy of Online Real-time Quality Measurement and Feedback Video-based CPR Training Program
The purpose of this study is to evaluate the effectiveness of a new online real-time quality measurement and feedback video-based CPR training program. The study participants will be allocated to three different CPR training programs: online real-time quality measurement and feedback video-based CPR training program, online real-time feedback video-based CPR training without quality measurement program, and conventional CPR training program. After CPR training, each participant will perform a 6 minute CPR simulation test. The investigators will compare the quality of chest compression between the three study groups. The investigators hypothesize that the new online real-time quality measurement and feedback video-based CPR training program is non-inferior to the preexisting conventional CPR training program and is superior to online real-time feedback video-based CPR training without quality measurement.
Read the detailed description
Bystander CPR 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. Preexisting CPR education was conducted under face-to-face contact with instructors and multiple trainees gathering 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 online real-time quality measurement and feedback video-based CPR training program that uses online video conferencing, Little Anne QCPR mannequin (Laerdal, Stavanger, Norway) and SkillGuide (Laerdal, Stavanger, Norway) device.
The purpose of this study is to evaluate the effectiveness of a new online real-time quality measurement and feedback video-based CPR training program. To evaluate the effectiveness of the new CPR training program the investigators propose to conduct a randomized clinical trial with three arms: online real-time quality measurement and feedback video-based CPR training program, online real-time feedback video-based CPR training without quality measurement program, and conventional CPR training program. 60 non healthcare provider, healthy adult volunteers will be randomized to each study arm. After CPR training, each participant will perform a 6 minute CPR simulation test. The investigators will measure the depth and rate of chest compression, hand positioning during chest compression, no-flow time and start to chest compression time.
The primary outcome of the study is mean chest compression depth. Chest compression rate, hand position, total no flow time, and time to chest compression will also be measured. The investigators hypothesize that the new online real-time quality measurement and feedback video-based CPR training program is non-inferior to the preexisting conventional CPR training program and is superior to online real-time feedback video-based CPR training without quality measurement.
- Conditions
- Cardiopulmonary Resuscitation, Education
- Being tested
- Online real-time quality measurement and feedback video-based CPR training, Online real-time feedback video-based CPR training without quality measurement, Conventional CPR training
- Keywords
- Cardiopulmonary Resuscitation, Education, Out-Of-Hospital Cardiac Arrest
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online real-time quality measurement and feedback video-based CPR trainingOther
Participants in the online real-time quality measurement and feedback video-based CPR training program group will access an online training center with laptop computers provided by the researcher. All education and communication is conducted online. The study instructors shows the study participants an edited version of the CPR training video used in the conventional CPR training program. A Little Anne QCPR mannequin (Laerdal, Stavanger, Norway) and SkillGuide (Laerdal, Stavanger, Norway) are provided so that the participants can use while watching the video and during the following hands-on practice session.
After watching the video, hands-on practice will be conducted by the instructor on-line. The instructor will watch each individual participants CPR performance via video conferencing and collect real-time performance data using the QCPR mannequin device. Using this information, the instructor will provide real-time online feedback to participants.
Online real-time feedback video-based CPR training without quality measurementOther
Participants in the online real-time feedback video-based CPR training without quality measurement program group will access an online training center with laptop computers provided by the researcher. All education and communication is conducted online. When study participants access the online training center, study instructors shows the study participants an edited version of the CPR training video used in the conventional CPR training program. A Little Anne QCPR mannequin (Laerdal, Stavanger, Norway) is provided so that the participants can use while watching the video and during the following hands-on practice session.
After watching the video, hands-on practice will be conducted by the instructor on-line. The instructor will watch each individual participants CPR performance via video conferencing. The instructor will provide real-time online feedback to participants.
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 mannequin (Laerdal, Stavanger, Norway) and SkillGuide (Laerdal, Stavanger, Norway) device are provided to measure and give feedback on the participants CPR performance.
| Study group | Role | What they receive |
|---|---|---|
| Online real-time CPR training program | Experimental | Online real-time quality measurement and feedback video-based CPR training will be provided to participants Receives: Other: Online real-time quality measurement and feedback video-based CPR training |
| Online real-time CPR training without quality measurement program | Active comparator | Online real-time feedback video-based CPR training without quality measurement will be provided to participants Receives: Other: Online real-time feedback video-based CPR training without quality measurement |
| Conventional CPR training program | Placebo 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.
Chest compression depth
Depth of chest compressions measured in millimeters
Measured: Assessed during 6 minute CPR simulation test
Secondary outcomes (4)
Chest compression rate
Rate of chest compression per minute
Measured: Assessed during 6 minute CPR simulation test
Hand position
Correct hand position measured by QCPR mannequin
Measured: Assessed during 6 minute CPR simulation test
No flow time
Time with no chest compression after start of chest compression
Measured: Assessed during 6 minute CPR simulation test
Time to chest compression
Time from start of simulation to start of chest compression
Measured: Assessed during 6 minute CPR simulation test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start11 Dec 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Han Kim, Seoul National University Hospital
- Investigators
- TAE HAN KIM, MD, Study chair, SMG-SNU Boramae Medical CenterSTEPHEN GW LEE, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656405
- Sponsor's protocol ID
- 30-2020-232
- Status last verified
- May 2021
- First submitted
- 30 Nov 2020
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim TH, Lee YJ, Lee EJ, Ro YS, Lee K, Lee H, Jang DB, Song KJ, Shin SD, Myklebust H, Birkenes TS. Comparison of Cardiopulmonary Resuscitation Quality Between Standard Versus Telephone-Basic Life Support Training Program in Middle-Aged and Elderly Housewives: A Randomized Simulation Study. Simul Healthc. 2018 Feb;13(1):27-32. doi: 10.1097/SIH.0000000000000286.
PubMed 29369963Park 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 32604135Cheng A, Nadkarni VM, Mancini MB, Hunt EA, Sinz EH, Merchant RM, Donoghue A, Duff JP, Eppich W, Auerbach M, Bigham BL, Blewer AL, Chan PS, Bhanji F; American Heart Association Education Science Investigators; and on behalf of the American Heart Association Education Science and Programs Committee, Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; Council on Cardiovascular and Stroke Nursing; and Council on Quality of Care and Outcomes Research. Resuscitation Education Science: Educational Strategies to Improve Outcomes From Cardiac Arrest: A Scientific Statement From the American Heart Association. Circulation. 2018 Aug 7;138(6):e82-e122. doi: 10.1161/CIR.0000000000000583.
PubMed 29930020Baldi E, Cornara S, Contri E, Epis F, Fina D, Zelaschi B, Dossena C, Fichtner F, Tonani M, Di Maggio M, Zambaiti E, Somaschini A. Real-time visual feedback during training improves laypersons' CPR quality: a randomized controlled manikin study. CJEM. 2017 Nov;19(6):480-487. doi: 10.1017/cem.2016.410. Epub 2017 Jan 24.
PubMed 28115027
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Online Real-time Quality Measurement and Feedback Video-based CPR Training Program
- ClinicalTrials.gov ID
- NCT04656405
- Acronym / sponsor ID
- 30-2020-232
- Conditions
- Cardiopulmonary Resuscitation, Education
- Keywords
- Cardiopulmonary Resuscitation, Education, Out-Of-Hospital Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 7 Dec 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.
The purpose of this study is to evaluate the effectiveness of a new online real-time quality measurement and feedback video-based CPR training program. The study participants will be allocated to three different CPR training programs: online real-time quality measurement and feedback video-based CPR training program, online real-time feedback video-based CPR training without quality measurement program, and conventional CPR training program. After CPR training, each participant will perform a 6 minute CPR simulation test. The investigators will compare the quality of chest compression between the three study groups. The investigators hypothesize that the new online real-time quality measurement and feedback video-based CPR training program is non-inferior to the preexisting conventional CPR training program and is superior to online real-time feedback video-based CPR training without quality measurement.
Detailed description
Bystander CPR 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. Preexisting CPR education was conducted under face-to-face contact with instructors and multiple trainees gathering 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 online real-time quality measurement and feedback video-based CPR training program that uses online video conferencing, Little Anne QCPR mannequin (Laerdal, Stavanger, Norway) and SkillGuide (Laerdal, Stavanger, Norway) device.
The purpose of this study is to evaluate the effectiveness of a new online real-time quality measurement and feedback video-based CPR training program. To evaluate the effectiveness of the new CPR training program the investigators propose to conduct a randomized clinical trial with three arms: online real-time quality measurement and feedback video-based CPR training program, online real-time feedback video-based CPR training without quality measurement program, and conventional CPR training program. 60 non healthcare provider, healthy adult volunteers will be randomized to each study arm. After CPR training, each participant will perform a 6 minute CPR simulation test. The investigators will measure the depth and rate of chest compression, hand positioning during chest compression, no-flow time and start to chest compression time.
The primary outcome of the study is mean chest compression depth. Chest compression rate, hand position, total no flow time, and time to chest compression will also be measured. The investigators hypothesize that the new online real-time quality measurement and feedback video-based CPR training program is non-inferior to the preexisting conventional CPR training program and is superior to online real-time feedback video-based CPR training without quality measurement.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Online real-time CPR training program | Experimental | Other: Online real-time quality measurement and feedback video-based CPR trainingOnline real-time quality measurement and feedback video-based CPR training will be provided to participants |
| Online real-time CPR training without quality measurement program | Active comparator | Other: Online real-time feedback video-based CPR training without quality measurementOnline real-time feedback video-based CPR training without quality measurement will be provided to participants |
| Conventional CPR training program | Placebo comparator | Other: Conventional CPR trainingConventional CPR training will be provided to participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteers aged 18 years or older
Key exclusion criteria (6 listed)
- Healthcare providers
- Participants with chronic lung diseases
- Participants with cardiovascular diseases
- Participants with visual disabilities
- Participants with hearing 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 |
|---|---|---|
| Online real-time quality measurement and feedback video-based CPR trainingParticipants in the online real-time quality measurement and feedback video-based CPR training program group will access an online training center with laptop computers provided by the researcher. All education and communication is conducted online. The study instructors shows the study participants an edited version of the CPR training video used in the conventional CPR training program. A Little Anne QCPR mannequin (Laerdal, Stavanger, Norway) and SkillGuide (Laerdal, Stavanger, Norway) are provided so that the participants can use while watching the video and during the following hands-on practice session. After watching the video, hands-on practice will be conducted by the instructor on-line. The instructor will watch each individual participants CPR performance via video conferencing and collect real-time performance data using the QCPR mannequin device. Using this information, the instructor will provide real-time online feedback to participants. | Other | Online real-time CPR training program |
| Online real-time feedback video-based CPR training without quality measurementParticipants in the online real-time feedback video-based CPR training without quality measurement program group will access an online training center with laptop computers provided by the researcher. All education and communication is conducted online. When study participants access the online training center, study instructors shows the study participants an edited version of the CPR training video used in the conventional CPR training program. A Little Anne QCPR mannequin (Laerdal, Stavanger, Norway) is provided so that the participants can use while watching the video and during the following hands-on practice session. After watching the video, hands-on practice will be conducted by the instructor on-line. The instructor will watch each individual participants CPR performance via video conferencing. The instructor will provide real-time online feedback to participants. | Other | Online real-time CPR training without quality measurement program |
| 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 mannequin (Laerdal, Stavanger, Norway) and SkillGuide (Laerdal, Stavanger, Norway) device are provided to measure and give feedback on the participants CPR performance. | Other | Conventional CPR training program |
Primary outcome
Chest compression depth
Time frame: Assessed during 6 minute CPR simulation test
Depth of chest compressions measured in millimeters
4 secondary outcomes
Chest compression rate
Time frame: Assessed during 6 minute CPR simulation test
Hand position
Time frame: Assessed during 6 minute CPR simulation test
No flow time
Time frame: Assessed during 6 minute CPR simulation test
Time to chest compression
Time frame: Assessed during 6 minute CPR simulation test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Background: PubMed 29369963Kim TH, Lee YJ, Lee EJ, Ro YS, Lee K, Lee H, Jang DB, Song KJ, Shin SD, Myklebust H, Birkenes TS. Comparison of Cardiopulmonary Resuscitation Quality Between Standard Versus Telephone-Basic Life Support Training Program in Middle-Aged and Elderly Housewives: A Randomized Simulation Study. Simul Healthc. 2018 Feb;13(1):27-32. doi: 10.1097/SIH.0000000000000286.
- 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.
- Background: PubMed 29930020Cheng A, Nadkarni VM, Mancini MB, Hunt EA, Sinz EH, Merchant RM, Donoghue A, Duff JP, Eppich W, Auerbach M, Bigham BL, Blewer AL, Chan PS, Bhanji F; American Heart Association Education Science Investigators; and on behalf of the American Heart Association Education Science and Programs Committee, Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; Council on Cardiovascular and Stroke Nursing; and Council on Quality of Care and Outcomes Research. Resuscitation Education Science: Educational Strategies to Improve Outcomes From Cardiac Arrest: A Scientific Statement From the American Heart Association. Circulation. 2018 Aug 7;138(6):e82-e122. doi: 10.1161/CIR.0000000000000583.
- Background: PubMed 28115027Baldi E, Cornara S, Contri E, Epis F, Fina D, Zelaschi B, Dossena C, Fichtner F, Tonani M, Di Maggio M, Zambaiti E, Somaschini A. Real-time visual feedback during training improves laypersons' CPR quality: a randomized controlled manikin study. CJEM. 2017 Nov;19(6):480-487. doi: 10.1017/cem.2016.410. Epub 2017 Jan 24.
- 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.
TAE HAN KIM, MD study chair
SMG-SNU Boramae Medical Center
STEPHEN GW LEE, MD principal investigator
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 Online real-time quality measurement and feedback video-based CPR training, Online real-time feedback video-based CPR training without quality measurement and Conventional CPR training in people with Cardiopulmonary Resuscitation and Education, 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 6 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 18 May 2021. 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. 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?
Contact STEPHEN GW LEE, MD (82)-10-5124-8415, LEESTEPHENGYUNGWON@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest compression depth (time frame: Assessed during 6 minute CPR simulation test). 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 NCT04656405, which also lists 4 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 18 May 2021; AzTrials last refreshed its copy on 3 Nov 2026.