Lowlands Saves Lives: A Randomized Trial Comparing CPR-quality Between Face-to-face vs. Lifesaver VR Training

NCT ID: NCT04013633

Last Updated: 2020-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

381 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-16

Study Completion Date

2020-08-18

Brief Summary

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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

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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.

Conditions

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Cardiac Arrest Cardiopulmonary Arrest Out-Of-Hospital Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors are blinded for study groups

Study Groups

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Lifesaver virtual reality (VR) training

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

Group Type EXPERIMENTAL

Lifesaver virtual reality training

Intervention Type OTHER

CPR training using the Lifesaver virtual reality application

Face-to-face training

A short face-to-face CPR training based on international guidelines provided by certified instructors

Group Type ACTIVE_COMPARATOR

Face-to-face training

Intervention Type OTHER

Short face-to-face CPR training

Interventions

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Lifesaver virtual reality training

CPR training using the Lifesaver virtual reality application

Intervention Type OTHER

Face-to-face training

Short face-to-face CPR training

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Niels van Royen, MD, PhD

Role: STUDY_CHAIR

Radboud University Medical Center

Locations

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Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 26477418 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26473002 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36228807 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35587346 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33442988 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31753903 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31734702 (View on PubMed)

Other Identifiers

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2019-5422

Identifier Type: -

Identifier Source: org_study_id

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