Effectiveness of Extended Reality CPR Training Methods

Virtual Reality Clinical Trial

Official title:

Comparison of Extended Reality and Conventional Methods of Basic Life Support Training: Protocol for a Multinational Pragmatic Clinical Trial (XR BLS Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04736888
• Other study ID #: CBS2.0
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: July 10, 2024

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: Dong Keon Lee, MD
• Phone: +82-31-787-7579
• Email: goldenegg[@]snubh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to explore the efficacy and safety of the extended reality (XR)-based basic life support (BLS) training.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: July 10, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Basic Cardiac Life Support
• Virtual Reality

Intervention

Other:
• extended-reality CPR training
extended-reality technologies based CPR training module
• conventional CPR training
conventional CPR training with video

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (4)

Lead Sponsor	Collaborator
Seoul National University Hospital	Children's Hospital Los Angeles, Royal Manchester Children's Hospital, Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (20)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — 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, 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean compression depth, mm	compression depth	Test sessions on day 1 (during 5 minutes) after 1 hour training
Secondary	the total number of chest compressions (n)	The total number of chest compressions	Test sessions on day 1 (during 5 minutes) after 1 hour training
Secondary	the mean chest compression depth(mm)	compression depth between 5cm and 6cm	Test sessions on day 1 (during 5 minutes) after 1 hour training
Secondary	correct hand position (n, percent)	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
Secondary	adequate compression depth (n, percent)	compression depth between 5cm and 6cm	Test sessions on day 1 (during 5 minutes) after 1 hour training
Secondary	compression and full release (n, percent)	full release after chest compression	Test sessions on day 1 (during 5 minutes) after 1 hour training
Secondary	mean compression rate (number per minute)	mean compression rate	Test sessions on day 1 (during 5 minutes) after 1 hour training
Secondary	adequate compression rate (percent)	compression rate between 100 and 120 per minute	Test sessions on day 1 (during 5 minutes) after 1 hour training
Secondary	adequate compression depth and rate (percent)	adequate compression death and rate, simultaneously	Test sessions on day 1 (during 5 minutes) after 1 hour training
Secondary	hands-off time (sec)	Interruptions of chest compressions during cardiopulmonary resuscitation	Test sessions on day 1 (during 5 minutes) after 1 hour training
Secondary	The time interval from arrival on the scene to the first chest compression (sec)	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
Secondary	AED use	Done/Not done	Test sessions on day 1 (during 5 minutes) after 1 hour training
Secondary	Correct AED use	Yes/No	Test sessions on day 1 (during 5 minutes) after 1 hour training
Secondary	Time from powering on the AED to defibrillation (sec)	Time from powering on the AED to defibrillation (sec)	Test sessions on day 1 (during 5 minutes) after 1 hour training
Secondary	Time from checking for a response to defibrillation (sec)	Time from checking for a response to defibrillation (sec)	Test sessions on day 1 (during 5 minutes) after 1 hour training