Lowlands Saves Lives: A Randomized Trial Comparing CPR-quality Between Face-to-face vs. Lifesaver VR Training
Primary Purpose
Cardiac Arrest, Cardiopulmonary Arrest, Out-Of-Hospital Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Lifesaver virtual reality training
Face-to-face training
Sponsored by
About this trial
This is an interventional other trial for Cardiac Arrest focused on measuring Cardiopulmonary resuscitation (CPR), Basic life support (BLS), Virtual reality (VR), Education, Lay-person training
Eligibility Criteria
Inclusion Criteria:
- Adult (≥18 years).
- Provide informed consent.
Exclusion Criteria:
- Alcohol level >0.5‰ and not able to perform tandem gait test.
- For any reason not being able to partake in the face-to-face or VR-app training (e.g. clear alcohol or drugs intoxication).
- For any reason not being able to perform the CPR test on the CPR-manikin (e.g. clear alcohol or drugs intoxication).
Sites / Locations
- Radboud University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lifesaver virtual reality (VR) training
Face-to-face training
Arm Description
Training using the Lifesaver VR application. Lifesaver VR is an interactive game that can be played on smartphones allowing users to 'resuscitate' a victim of cardiac arrest, while wearing VR-goggles showing a filmed CPR-scenario
A short face-to-face CPR training based on international guidelines provided by certified instructors
Outcomes
Primary Outcome Measures
Chest compression quality
Chest compression quality measured as depth (mm) and rate (compressions/min) measured using CPR manikin
Secondary Outcome Measures
Flow fraction
Percentage of time where compressions are given, measured using CPR manikin
CPR performance score
CPR performance score from BLS-training checklist
Full Information
NCT ID
NCT04013633
First Posted
July 5, 2019
Last Updated
October 8, 2020
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04013633
Brief Title
Lowlands Saves Lives: A Randomized Trial Comparing CPR-quality Between Face-to-face vs. Lifesaver VR Training
Official Title
Lowlands Saves Lives: A Randomized Trial to Assess the Impact of Face-to-face vs. Virtual Reality Training Using the Lifesaver VR-app on the Quality of Cardiopulmonary Resuscitation.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 16, 2019 (Actual)
Primary Completion Date
August 18, 2019 (Actual)
Study Completion Date
August 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the Lowlands Saves Lives trial is to compare the quality of cardiopulmonary resuscitation (CPR) between face-to-face versus Lifesaver Virtual Reality smartphone application trained participants using a randomized controlled trial.
Detailed Description
In order to optimize survival after out-of-hospital cardiac arrest, basic life support (BLS) training of lay-person volunteers is essential. Face-to-face training has long been considered the standard, but new training-methods have emerged, of which the Lifesaver VR (developed by the UK Resuscitation Council) app seems promising. It is unknown which training method results in the highest quality of cardiopulmonary resuscitation (CPR). Therefore, we conduct this randomized controlled trial in which subjects will be randomized to either one of the two training methods. Following the training, all participants will undergo CPR-quality testing using certified manikins and blinded assessors.
The present study will be conducted during Lowlands Science, a section of the Lowlands music festival exclusively dedicated to science. Lowlands will be held on August 16-18 of 2019 and over 50.000 attendees are expected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Cardiopulmonary Arrest, Out-Of-Hospital Cardiac Arrest
Keywords
Cardiopulmonary resuscitation (CPR), Basic life support (BLS), Virtual reality (VR), Education, Lay-person training
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Outcome assessors are blinded for study groups
Allocation
Randomized
Enrollment
381 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifesaver virtual reality (VR) training
Arm Type
Experimental
Arm Description
Training using the Lifesaver VR application. Lifesaver VR is an interactive game that can be played on smartphones allowing users to 'resuscitate' a victim of cardiac arrest, while wearing VR-goggles showing a filmed CPR-scenario
Arm Title
Face-to-face training
Arm Type
Active Comparator
Arm Description
A short face-to-face CPR training based on international guidelines provided by certified instructors
Intervention Type
Other
Intervention Name(s)
Lifesaver virtual reality training
Intervention Description
CPR training using the Lifesaver virtual reality application
Intervention Type
Other
Intervention Name(s)
Face-to-face training
Intervention Description
Short face-to-face CPR training
Primary Outcome Measure Information:
Title
Chest compression quality
Description
Chest compression quality measured as depth (mm) and rate (compressions/min) measured using CPR manikin
Time Frame
During post-training CPR test, performed on the same day as the training
Secondary Outcome Measure Information:
Title
Flow fraction
Description
Percentage of time where compressions are given, measured using CPR manikin
Time Frame
During post-training CPR test, performed on the same day as the training
Title
CPR performance score
Description
CPR performance score from BLS-training checklist
Time Frame
During post-training CPR test, performed on the same day as the training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult (≥18 years).
Provide informed consent.
Exclusion Criteria:
Alcohol level >0.5‰ and not able to perform tandem gait test.
For any reason not being able to partake in the face-to-face or VR-app training (e.g. clear alcohol or drugs intoxication).
For any reason not being able to perform the CPR test on the CPR-manikin (e.g. clear alcohol or drugs intoxication).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels van Royen, MD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Radboud University Medical Center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525GA
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26477418
Citation
Greif R, Lockey AS, Conaghan P, Lippert A, De Vries W, Monsieurs KG; Education and implementation of resuscitation section Collaborators; Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 10. Education and implementation of resuscitation. Resuscitation. 2015 Oct;95:288-301. doi: 10.1016/j.resuscitation.2015.07.032. Epub 2015 Oct 15. No abstract available.
Results Reference
background
PubMed Identifier
26473002
Citation
Bhanji F, Donoghue AJ, Wolff MS, Flores GE, Halamek LP, Berman JM, Sinz EH, Cheng A. Part 14: Education: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S561-73. doi: 10.1161/CIR.0000000000000268. No abstract available.
Results Reference
background
PubMed Identifier
36228807
Citation
Nas J, Thannhauser J, Vart P, van Geuns R, Muijsers H, Mol J, Aarts G, Konijnenberg L, Gommans D, Ahoud-Schoenmakers S, Vos JL, van Royen N, Bonnes JL, Brouwer MA. The impact of alcohol use on the quality of cardiopulmonary resuscitation among festival attendees: A prespecified analysis of a randomised trial. Resuscitation. 2022 Dec;181:12-19. doi: 10.1016/j.resuscitation.2022.10.002. Epub 2022 Oct 11.
Results Reference
derived
PubMed Identifier
35587346
Citation
Nas J, Thannhauser J, Konijnenberg LSF, van Geuns RM, van Royen N, Bonnes JL, Brouwer MA. Long-term Effect of Face-to-Face vs Virtual Reality Cardiopulmonary Resuscitation (CPR) Training on Willingness to Perform CPR, Retention of Knowledge, and Dissemination of CPR Awareness: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2212964. doi: 10.1001/jamanetworkopen.2022.12964.
Results Reference
derived
PubMed Identifier
33442988
Citation
Nas J, Thannhauser J, van Geuns RM, van Royen N, Bonnes JL, Brouwer MA. Optimal Combination of Chest Compression Depth and Rate in Virtual Reality Resuscitation Training: A Post Hoc Analysis of the Randomized Lowlands Saves Lives Trial. J Am Heart Assoc. 2021 Jan 19;10(2):e017367. doi: 10.1161/JAHA.120.017367. Epub 2021 Jan 14.
Results Reference
derived
PubMed Identifier
31753903
Citation
Nas J, Thannhauser J, Vart P, van Geuns RJ, van Royen N, Bonnes JL, Brouwer MA. Rationale and design of the Lowlands Saves Lives trial: a randomised trial to compare CPR quality and long-term attitude towards CPR performance between face-to-face and virtual reality training with the Lifesaver VR app. BMJ Open. 2019 Nov 21;9(11):e033648. doi: 10.1136/bmjopen-2019-033648.
Results Reference
derived
PubMed Identifier
31734702
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.
Results Reference
derived
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Lowlands Saves Lives: A Randomized Trial Comparing CPR-quality Between Face-to-face vs. Lifesaver VR Training
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