- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04736888
Effectiveness of Extended Reality CPR Training Methods
Comparison of Extended Reality and Conventional Methods of Basic Life Support Training: Protocol for a Multinational Pragmatic Clinical Trial (XR BLS Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Conventional CPR training is based on the use of a manikin and a training video. Though several feedback devices have been developed to improve the effectiveness of the training, they were neither realistic nor immersive. In addition, in conventional training programs, trainees are constrained in terms of time and location, as they are usually kept to a schedule.
Virtual reality (VR) technology, which was designed to maximize immersion, could be used to overcome those limitations, which in turn may improve the effectiveness of CPR training. However, even with VR technology, procedures such as chest compressions, ventilation, and defibrillation cannot be implemented as in the real world. Extended reality (XR), which combines the virtual and real worlds, could overcome these limitations by facilitating the use of real-world manikins in the virtual environment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals who are not healthcare providers and are 18 years old or older
Exclusion Criteria:
Participants who
- are not capable of performing either the training or the CPR test due to physical or cognitive limitations
- have upper extremity injuries
- are pregnant
- experience dizziness, headache, or motion sickness during the 2-minute XR device adaptation period that prevents them from participating in the simulation study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Conventional group
Conventional CPR training consists of a BLS video and a manikin equipped with a feedback device.
|
conventional CPR training with video
|
|
Active Comparator: XR group
The XR group participants will be provided training via the XR BLS module and are allotted an additional 2 minutes that is needed to adapt to the XR equipment.
|
extended-reality technologies based CPR training module
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mean compression depth, mm
Time Frame: Test sessions on day 1 (during 5 minutes) after 1 hour training
|
compression depth
|
Test sessions on day 1 (during 5 minutes) after 1 hour training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the total number of chest compressions (n)
Time Frame: Test sessions on day 1 (during 5 minutes) after 1 hour training
|
The total number of chest compressions
|
Test sessions on day 1 (during 5 minutes) after 1 hour training
|
|
the mean chest compression depth(mm)
Time Frame: Test sessions on day 1 (during 5 minutes) after 1 hour training
|
compression depth between 5cm and 6cm
|
Test sessions on day 1 (during 5 minutes) after 1 hour training
|
|
correct hand position (n, percent)
Time Frame: Test sessions on day 1 (during 5 minutes) after 1 hour training
|
The American Heart Association (AHA) guidelines describe the correct hand position for chest compression as the lower half of the victim's sternum in the centre of the chest, between the nipples.
|
Test sessions on day 1 (during 5 minutes) after 1 hour training
|
|
adequate compression depth (n, percent)
Time Frame: Test sessions on day 1 (during 5 minutes) after 1 hour training
|
compression depth between 5cm and 6cm
|
Test sessions on day 1 (during 5 minutes) after 1 hour training
|
|
compression and full release (n, percent)
Time Frame: Test sessions on day 1 (during 5 minutes) after 1 hour training
|
full release after chest compression
|
Test sessions on day 1 (during 5 minutes) after 1 hour training
|
|
mean compression rate (number per minute)
Time Frame: Test sessions on day 1 (during 5 minutes) after 1 hour training
|
mean compression rate
|
Test sessions on day 1 (during 5 minutes) after 1 hour training
|
|
adequate compression rate (percent)
Time Frame: Test sessions on day 1 (during 5 minutes) after 1 hour training
|
compression rate between 100 and 120 per minute
|
Test sessions on day 1 (during 5 minutes) after 1 hour training
|
|
adequate compression depth and rate (percent)
Time Frame: Test sessions on day 1 (during 5 minutes) after 1 hour training
|
adequate compression death and rate, simultaneously
|
Test sessions on day 1 (during 5 minutes) after 1 hour training
|
|
hands-off time (sec)
Time Frame: Test sessions on day 1 (during 5 minutes) after 1 hour training
|
Interruptions of chest compressions during cardiopulmonary resuscitation
|
Test sessions on day 1 (during 5 minutes) after 1 hour training
|
|
The time interval from arrival on the scene to the first chest compression (sec)
Time Frame: Test sessions on day 1 (during 5 minutes) after 1 hour training
|
The time interval from arrival on the scene to the first chest compression.
|
Test sessions on day 1 (during 5 minutes) after 1 hour training
|
|
AED use
Time Frame: Test sessions on day 1 (during 5 minutes) after 1 hour training
|
Done/Not done
|
Test sessions on day 1 (during 5 minutes) after 1 hour training
|
|
Correct AED use
Time Frame: Test sessions on day 1 (during 5 minutes) after 1 hour training
|
Yes/No
|
Test sessions on day 1 (during 5 minutes) after 1 hour training
|
|
Time from powering on the AED to defibrillation (sec)
Time Frame: Test sessions on day 1 (during 5 minutes) after 1 hour training
|
Time from powering on the AED to defibrillation (sec)
|
Test sessions on day 1 (during 5 minutes) after 1 hour training
|
|
Time from checking for a response to defibrillation (sec)
Time Frame: Test sessions on day 1 (during 5 minutes) after 1 hour training
|
Time from checking for a response to defibrillation (sec)
|
Test sessions on day 1 (during 5 minutes) after 1 hour training
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: You Hwan Jo, PhD, Seoul National University Bundang Hospital
Publications and helpful links
General Publications
- Iwashyna TJ. Survivorship will be the defining challenge of critical care in the 21st century. Ann Intern Med. 2010 Aug 3;153(3):204-5. doi: 10.7326/0003-4819-153-3-201008030-00013. No abstract available.
- Semeraro F, Frisoli A, Loconsole C, Banno F, Tammaro G, Imbriaco G, Marchetti L, Cerchiari EL. Motion detection technology as a tool for cardiopulmonary resuscitation (CPR) quality training: a randomised crossover mannequin pilot study. Resuscitation. 2013 Apr;84(4):501-7. doi: 10.1016/j.resuscitation.2012.12.006. Epub 2012 Dec 10.
- Semeraro F, Taggi F, Tammaro G, Imbriaco G, Marchetti L, Cerchiari EL. iCPR: a new application of high-quality cardiopulmonary resuscitation training. Resuscitation. 2011 Apr;82(4):436-41. doi: 10.1016/j.resuscitation.2010.11.023. Epub 2011 Jan 11.
- Semeraro F, Frisoli A, Bergamasco M, Cerchiari EL. Virtual reality enhanced mannequin (VREM) that is well received by resuscitation experts. Resuscitation. 2009 Apr;80(4):489-92. doi: 10.1016/j.resuscitation.2008.12.016. Epub 2009 Feb 8.
- Deakin CD. The chain of survival: Not all links are equal. Resuscitation. 2018 May;126:80-82. doi: 10.1016/j.resuscitation.2018.02.012. Epub 2018 Feb 19.
- Brady WJ, Mattu A, Slovis CM. Lay Responder Care for an Adult with Out-of-Hospital Cardiac Arrest. N Engl J Med. 2019 Dec 5;381(23):2242-2251. doi: 10.1056/NEJMra1802529. No abstract available.
- Ro YS, Shin SD, Song KJ, Hong SO, Kim YT, Cho SI. Bystander cardiopulmonary resuscitation training experience and self-efficacy of age and gender group: a nationwide community survey. Am J Emerg Med. 2016 Aug;34(8):1331-7. doi: 10.1016/j.ajem.2015.12.001. Epub 2015 Dec 7.
- Andrews C, Southworth MK, Silva JNA, Silva JR. Extended Reality in Medical Practice. Curr Treat Options Cardiovasc Med. 2019 Mar 30;21(4):18. doi: 10.1007/s11936-019-0722-7.
- 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.
- Anderson R, Sebaldt A, Lin Y, Cheng A. Optimal training frequency for acquisition and retention of high-quality CPR skills: A randomized trial. Resuscitation. 2019 Feb;135:153-161. doi: 10.1016/j.resuscitation.2018.10.033. Epub 2018 Nov 2.
- Bylow H, Karlsson T, Claesson A, Lepp M, Lindqvist J, Herlitz J. Self-learning training versus instructor-led training for basic life support: A cluster randomised trial. Resuscitation. 2019 Jun;139:122-132. doi: 10.1016/j.resuscitation.2019.03.026. Epub 2019 Mar 26.
- Roppolo LP, Pepe PE, Campbell L, Ohman K, Kulkarni H, Miller R, Idris A, Bean L, Bettes TN, Idris AH. Prospective, randomized trial of the effectiveness and retention of 30-min layperson training for cardiopulmonary resuscitation and automated external defibrillators: The American Airlines Study. Resuscitation. 2007 Aug;74(2):276-85. doi: 10.1016/j.resuscitation.2006.12.017. Epub 2007 Apr 23.
- Zapletal B, Greif R, Stumpf D, Nierscher FJ, Frantal S, Haugk M, Ruetzler K, Schlimp C, Fischer H. Comparing three CPR feedback devices and standard BLS in a single rescuer scenario: a randomised simulation study. Resuscitation. 2014 Apr;85(4):560-6. doi: 10.1016/j.resuscitation.2013.10.028. Epub 2013 Nov 8.
- Park S, Lee G. Full-immersion virtual reality: Adverse effects related to static balance. Neurosci Lett. 2020 Aug 10;733:134974. doi: 10.1016/j.neulet.2020.134974. Epub 2020 Apr 12.
- Edelson DP, Sasson C, Chan PS, Atkins DL, Aziz K, Becker LB, Berg RA, Bradley SM, Brooks SC, Cheng A, Escobedo M, Flores GE, Girotra S, Hsu A, Kamath-Rayne BD, Lee HC, Lehotsky RE, Mancini ME, Merchant RM, Nadkarni VM, Panchal AR, Peberdy MAR, Raymond TT, Walsh B, Wang DS, Zelop CM, Topjian AA; American Heart Association ECC Interim COVID Guidance Authors. Interim Guidance for Basic and Advanced Life Support in Adults, Children, and Neonates With Suspected or Confirmed COVID-19: From the Emergency Cardiovascular Care Committee and Get With The Guidelines-Resuscitation Adult and Pediatric Task Forces of the American Heart Association. Circulation. 2020 Jun 23;141(25):e933-e943. doi: 10.1161/CIRCULATIONAHA.120.047463. Epub 2020 Apr 9. 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.
- Craig-Brangan KJ, Day MP. Update: AHA guidelines for CPR and emergency cardiovascular care. Nursing. 2020 Jun;50(6):58-61. doi: 10.1097/01.NURSE.0000659320.66070.a9.
- Riggs M, Franklin R, Saylany L. Associations between cardiopulmonary resuscitation (CPR) knowledge, self-efficacy, training history and willingness to perform CPR and CPR psychomotor skills: A systematic review. Resuscitation. 2019 May;138:259-272. doi: 10.1016/j.resuscitation.2019.03.019. Epub 2019 Mar 27.
- Stiell IG, Brown SP, Nichol G, Cheskes S, Vaillancourt C, Callaway CW, Morrison LJ, Christenson J, Aufderheide TP, Davis DP, Free C, Hostler D, Stouffer JA, Idris AH; Resuscitation Outcomes Consortium Investigators. What is the optimal chest compression depth during out-of-hospital cardiac arrest resuscitation of adult patients? Circulation. 2014 Nov 25;130(22):1962-70. doi: 10.1161/CIRCULATIONAHA.114.008671. Epub 2014 Sep 24.
- Lee DK, Im CW, Jo YH, Chang T, Song JL, Luu C, Mackinnon R, Pillai S, Lee CN, Jheon S, Ahn S, Won SH. Comparison of extended reality and conventional methods of basic life support training: protocol for a multinational, pragmatic, noninferiority, randomised clinical trial (XR BLS trial). Trials. 2021 Dec 20;22(1):946. doi: 10.1186/s13063-021-05908-z.
- Grasner JT, Lefering R, Koster RW, Masterson S, Bottiger BW, Herlitz J, Wnent J, Tjelmeland IB, Ortiz FR, Maurer H, Baubin M, Mols P, Hadzibegovic I, Ioannides M, Skulec R, Wissenberg M, Salo A, Hubert H, Nikolaou NI, Loczi G, Svavarsdottir H, Semeraro F, Wright PJ, Clarens C, Pijls R, Cebula G, Correia VG, Cimpoesu D, Raffay V, Trenkler S, Markota A, Stromsoe A, Burkart R, Perkins GD, Bossaert LL; EuReCa ONE Collaborators. EuReCa ONE-27 Nations, ONE Europe, ONE Registry: A prospective one month analysis of out-of-hospital cardiac arrest outcomes in 27 countries in Europe. Resuscitation. 2016 Aug;105:188-95. doi: 10.1016/j.resuscitation.2016.06.004. Epub 2016 Jun 16. Erratum In: Resuscitation. 2016 Dec;109:145-146. doi: 10.1016/j.resuscitation.2016.10.001.
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CBS2.0
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
product manufactured in and exported from the U.S.
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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