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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04656405
Other study ID # 30-2020-232
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 11, 2020
Est. completion date March 31, 2022

Study information

Verified date May 2021
Source Seoul National University Hospital
Contact STEPHEN GW LEE, MD
Phone 82)-10-5124-8415
Email LEESTEPHENGYUNGWON@GMAIL.COM
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date March 31, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Volunteers aged 18 years or older Exclusion Criteria: - Healthcare providers - Participants with chronic lung diseases - Participants with cardiovascular diseases - Participants with visual disabilities - Participants with hearing disabilities - Participants with musculoskeletal disabilities

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Online real-time quality measurement and feedback video-based CPR training
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 measurement
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 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 mannequin (Laerdal, Stavanger, Norway) and SkillGuide (Laerdal, Stavanger, Norway) device are provided to measure and give feedback on the participants CPR performance.

Locations

Country Name City State
Korea, Republic of Seoul Metropolitan Government-Seoul National University Borame Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

Baldi 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. — View Citation

Cheng 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. Review. — View Citation

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. — 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 Chest compression depth Depth of chest compressions measured in millimeters Assessed during 6 minute CPR simulation test
Secondary Chest compression rate Rate of chest compression per minute Assessed during 6 minute CPR simulation test
Secondary Hand position Correct hand position measured by QCPR mannequin Assessed during 6 minute CPR simulation test
Secondary No flow time Time with no chest compression after start of chest compression Assessed during 6 minute CPR simulation test
Secondary Time to chest compression Time from start of simulation to start of chest compression Assessed during 6 minute CPR simulation test
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