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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05023616
Other study ID # H-2107-205-1239
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 26, 2021
Est. completion date August 31, 2022

Study information

Verified date October 2022
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date August 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Adults without prior CPR training within 6 months Exclusion Criteria: - Healthcare providers

Study Design


Intervention

Other:
Real-time home CPR training
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 training
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.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

Nolan JP, Monsieurs KG, Bossaert L, Böttiger 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. — View Citation

Panchal AR, Bartos JA, Cabañas 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Average compression depth Average compression depth of chest compression 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.
Secondary Proportion of adequate compression depth 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.
Secondary Average compression rate Average compression rate of chest compression 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.
Secondary Proportion of adequate compression rate Proportion of adequate compression rate 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.
Secondary No-flow fraction Proportion of no-flow time during 2 minutes of chest compression 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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