NCT04013633

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
381

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

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

July 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 16, 2019

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2020

Completed
Last Updated

October 9, 2020

Status Verified

October 1, 2020

Enrollment Period

2 days

First QC Date

July 5, 2019

Last Update Submit

October 8, 2020

Conditions

Cardiac ArrestCardiopulmonary ArrestOut-Of-Hospital Cardiac Arrest

Keywords

Cardiopulmonary resuscitation (CPR)Basic life support (BLS)Virtual reality (VR)EducationLay-person training

Outcome Measures

Primary Outcomes (1)

  • Chest compression quality

    Chest compression quality measured as depth (mm) and rate (compressions/min) measured using CPR manikin

    During post-training CPR test, performed on the same day as the training

Secondary Outcomes (2)

  • Flow fraction

    During post-training CPR test, performed on the same day as the training

  • CPR performance score

    During post-training CPR test, performed on the same day as the training

Study Arms (2)

Lifesaver virtual reality (VR) training

EXPERIMENTAL

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

Other: Lifesaver virtual reality training

Face-to-face training

ACTIVE COMPARATOR

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

Other: Face-to-face training

Interventions

Lifesaver virtual reality trainingOTHER

CPR training using the Lifesaver virtual reality application

Lifesaver virtual reality (VR) training
Face-to-face trainingOTHER

Short face-to-face CPR training

Face-to-face training

Eligibility Criteria

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

You may qualify if:

  • Adult (≥18 years).
  • Provide informed consent.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Related Publications (7)

  • 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.

    PMID: 26477418BACKGROUND

  • 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.

    PMID: 26473002BACKGROUND

  • 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.

    PMID: 36228807DERIVED

  • 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.

    PMID: 35587346DERIVED

  • 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.

    PMID: 33442988DERIVED

  • 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.

    PMID: 31753903DERIVED

  • 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: 31734702DERIVED

MeSH Terms

Conditions

Heart ArrestOut-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Niels van Royen, MD, PhD

    Radboud University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors are blinded for study groups
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2019

First Posted

July 10, 2019

Study Start

August 16, 2019

Primary Completion

August 18, 2019

Study Completion

August 18, 2020

Last Updated

October 9, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)