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出境医 / 临床实验 / Lowlands Saves Lives: A Randomized Trial Comparing CPR-quality Between Face-to-face vs. Lifesaver VR Training

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

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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Cardiopulmonary Arrest Out-Of-Hospital Cardiac Arrest Other: Lifesaver virtual reality training Other: Face-to-face training Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 381 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessors are blinded for study groups
Primary Purpose: Other
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.
Actual Study Start Date : August 16, 2019
Actual Primary Completion Date : August 18, 2019
Actual Study Completion Date : August 18, 2020
Arms and Interventions
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
 Other: Lifesaver virtual reality training
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
 Other: Face-to-face training
Short face-to-face CPR training
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
Contacts and Locations

Locations
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Netherlands
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525GA
Sponsors and Collaborators
Radboud University
Investigators
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Study Chair: Niels van Royen, MD, PhD Radboud University
Tracking Information
First Submitted Date  ICMJE July 5, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date October 9, 2020
Actual Study Start Date  ICMJE August 16, 2019
Actual Primary Completion Date August 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019) 		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
Original Primary Outcome Measures  ICMJE
 (submitted: July 5, 2019) 		Chest compression quality [ Time Frame: During post-training CPR test ]
Chest compression quality measured as depth (mm) and rate (compressions/min) measured using CPR manikin
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
  • Flow fraction [ Time Frame: During post-training CPR test ]
    Percentage of time where compressions are given, measured using CPR manikin
  • CPR performance score [ Time Frame: During post-training CPR test ]
    CPR performance score from BLS-training checklist
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lowlands Saves Lives: A Randomized Trial Comparing CPR-quality Between Face-to-face vs. Lifesaver VR Training
Official Title  ICMJE 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description:
Outcome assessors are blinded for study groups
Primary Purpose: Other
Condition  ICMJE
  • Cardiac Arrest
  • Cardiopulmonary Arrest
  • Out-Of-Hospital Cardiac Arrest
Intervention  ICMJE
  • Other: Lifesaver virtual reality training
    CPR training using the Lifesaver virtual reality application
  • Other: Face-to-face training
    Short face-to-face CPR training
Study Arms  ICMJE
  • 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
    Intervention: Other: Lifesaver virtual reality training
  • Active Comparator: Face-to-face training
    A short face-to-face CPR training based on international guidelines provided by certified instructors
    Intervention: Other: Face-to-face training
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.
  • 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. Review.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2020) 		381
Original Estimated Enrollment  ICMJE
 (submitted: July 5, 2019) 		300
Actual Study Completion Date  ICMJE August 18, 2020
Actual Primary Completion Date August 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04013633
Other Study ID Numbers  ICMJE 2019-5422
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Niels van Royen, MD, PhD Radboud University
PRS Account Radboud University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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