NCT04736888

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

September 10, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

January 29, 2021

Last Update Submit

November 22, 2024

Conditions

Keywords

Cardiopulmonary resuscitationBasic Cardiac Life SupportVirtual RealityExtended RealityEducation

Outcome Measures

Primary Outcomes (1)

  • mean compression depth, mm

    compression depth

    Test sessions on day 1 (during 5 minutes) after 1 hour training

Secondary Outcomes (14)

  • the total number of chest compressions (n)

    Test sessions on day 1 (during 5 minutes) after 1 hour training

  • the mean chest compression depth(mm)

    Test sessions on day 1 (during 5 minutes) after 1 hour training

  • correct hand position (n, percent)

    Test sessions on day 1 (during 5 minutes) after 1 hour training

  • adequate compression depth (n, percent)

    Test sessions on day 1 (during 5 minutes) after 1 hour training

  • compression and full release (n, percent)

    Test sessions on day 1 (during 5 minutes) after 1 hour training

  • +9 more secondary outcomes

Study Arms (2)

Conventional group

SHAM COMPARATOR

Conventional CPR training consists of a BLS video and a manikin equipped with a feedback device.

Other: conventional CPR training

XR group

ACTIVE COMPARATOR

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.

Other: extended-reality CPR training

Interventions

extended-reality technologies based CPR training module

XR group

conventional CPR training with video

Conventional group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who are not healthcare providers and are 18 years old or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Related Publications (21)

  • 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.

    PMID: 23238423BACKGROUND
  • 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.

    PMID: 21227560BACKGROUND
  • 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.

    PMID: 19203823BACKGROUND
  • 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.

    PMID: 20679565BACKGROUND
  • 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.

    PMID: 27321577BACKGROUND
  • 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.

    PMID: 29471008BACKGROUND
  • 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.

    PMID: 31800989BACKGROUND
  • 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.

    PMID: 27037129BACKGROUND
  • 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.

    PMID: 30929093BACKGROUND
  • 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.

    PMID: 31734702BACKGROUND
  • 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.

    PMID: 30391370BACKGROUND
  • 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.

    PMID: 30926451BACKGROUND
  • 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.

    PMID: 17452070BACKGROUND
  • 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.

    PMID: 24215730BACKGROUND
  • 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.

    PMID: 32294492BACKGROUND
  • 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.

    PMID: 32270695BACKGROUND
  • 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.

    PMID: 32525022BACKGROUND
  • 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.

    PMID: 32453156BACKGROUND
  • 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.

    PMID: 30928504BACKGROUND
  • 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.

    PMID: 25252721BACKGROUND
  • 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.

Study Officials

  • You Hwan Jo, PhD

    Seoul National University Bundang Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 3, 2021

Study Start

September 10, 2021

Primary Completion

September 9, 2024

Study Completion

September 9, 2024

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations