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Cardiac ArrestNCT04013633

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

A study testing Lifesaver virtual reality training and Face-to-face training in people with Cardiac Arrest and Cardiopulmonary Arrest, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Lifesaver virtual reality training and Face-to-face training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
381 participants
Where
1 siteNetherlands
Study dates
16 Aug 2019to 18 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboud University Medical Center

    Nijmegen, Gelderland, 6525GA

Other trials in Netherlands

About this study

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.

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.

Read the 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.

Being tested
Lifesaver virtual reality training, Face-to-face training
Keywords
Cardiopulmonary resuscitation (CPR), Basic life support (BLS), Virtual reality (VR), Education, Lay-person training
Medical subject headings
Heart Arrest, Out-of-Hospital Cardiac Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifesaver virtual reality trainingOther

    CPR training using the Lifesaver virtual reality application

  • Face-to-face trainingOther

    Short face-to-face CPR training

Study groups in NCT04013633
Study groupRoleWhat they receive
Lifesaver virtual reality (VR) trainingExperimentalTraining 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
Receives: Other: Lifesaver virtual reality training
Face-to-face trainingActive comparatorA short face-to-face CPR training based on international guidelines provided by certified instructors
Receives: Other: Face-to-face training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Chest compression quality

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

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

Secondary outcomes (2)

  1. Flow fraction

    Percentage of time where compressions are given, measured using CPR manikin

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

  2. CPR performance score

    CPR performance score from BLS-training checklist

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2019
  2. Study start16 Aug 2019
  3. Primary completion18 Aug 2019
  4. Study completion18 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
381 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04013633
Sponsor's protocol ID
2019-5422
Status last verified
Oct 2020
First submitted
5 Jul 2019
Last updated
9 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26477418

  • 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.

    PubMed 26473002

  • 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.

    PubMed 36228807

  • 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.

    PubMed 35587346

  • 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.

    PubMed 33442988

  • 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.

    PubMed 31753903

  • 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.

    PubMed 31734702

Questions about this trial

What is this clinical trial studying?

A study testing Lifesaver virtual reality training and Face-to-face training in people with Cardiac Arrest and Cardiopulmonary Arrest, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chest compression quality (time frame: During post-training CPR test, performed on the same day as the training). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04013633, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.

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