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

October 8, 2020 updated by: Radboud University Medical Center

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

381

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525GA
        • Radboud University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
CPR training using the Lifesaver virtual reality application
Active Comparator: Face-to-face training
A short face-to-face CPR training based on international guidelines provided by certified instructors
Short face-to-face CPR training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chest compression quality
Time Frame: During post-training CPR test, performed on the same day as the training
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow fraction
Time Frame: During post-training CPR test, performed on the same day as the training
Percentage of time where compressions are given, measured using CPR manikin
During post-training CPR test, performed on the same day as the training
CPR performance score
Time Frame: During post-training CPR test, performed on the same day as the training
CPR performance score from BLS-training checklist
During post-training CPR test, performed on the same day as the training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Niels van Royen, MD, PhD, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2019

Primary Completion (Actual)

August 18, 2019

Study Completion (Actual)

August 18, 2020

Study Registration Dates

First Submitted

July 5, 2019

First Submitted That Met QC Criteria

July 5, 2019

First Posted (Actual)

July 10, 2019

Study Record Updates

Last Update Posted (Actual)

October 9, 2020

Last Update Submitted That Met QC Criteria

October 8, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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