- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05023616
Evaluation of Efficacy of Online Real-time Home CPR Training Program
Evaluation of Efficacy of Online Real-time Home CPR Training Program : a Randomized Open-label Clinical Trial
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults without prior CPR training within 6 months
Exclusion Criteria:
- Healthcare providers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Real-time home CPR training
Online real-time home CPR(cardiopulmonary resuscitation) training will be provided to participants
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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.
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ACTIVE_COMPARATOR: Conventional CPR training
Conventional CPR training will be provided to participants
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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Average compression depth of chest compression performed for 2 minutes
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Proportion of adequate compression depth performed for 2 minutes
|
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.
|
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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.
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Average compression rate of chest compression performed for 2 minutes
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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.
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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.
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Proportion of adequate compression rate performed for 2 minutes
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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.
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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.
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Proportion of no-flow time during 2 minutes of chest compression
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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.
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Collaborators and Investigators
Investigators
- Study Chair: Ki Jeong Hong, MD, Department of Emergency Medicine, Seoul National University Hospital
- Principal Investigator: STEPHEN GW LEE, MD, Department of Emergency Medicine, SMG-SNU Boramae Medical Center
- Principal Investigator: Seulki Choi, MD, Department of Emergency Medicine, Seoul National University Hospital
Publications and helpful links
General 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.
- Nolan 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.
- Cheng 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.
- Nas 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.
- Park 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2107-205-1239
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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