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

Cardiac Arrest Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04013633
• Other study ID #: 2019-5422
• Status: Completed
• Phase: N/A
• Start date: August 16, 2019
• Est. completion date: August 18, 2020

Study information

• Verified date: October 2020
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: August 18, 2020
• Est. primary completion date: August 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cardiac Arrest
• Cardiopulmonary Arrest
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Other:
• Lifesaver virtual reality training
CPR training using the Lifesaver virtual reality application
• Face-to-face training
Short face-to-face CPR training

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Center	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Flow fraction	Percentage of time where compressions are given, measured using CPR manikin	During post-training CPR test, performed on the same day as the training
Secondary	CPR performance score	CPR performance score from BLS-training checklist	During post-training CPR test, performed on the same day as the training