The Scandinavian AED and Mobile Bystander Activation Trial

Overview

Sudden cardiac death is a major health problem in the western world. In Europe alone nearly 300 000 patients are affected annually. The majority of victims suffering from an Out-of-Hospital Cardiac Arrest (OHCA have an initial cardiac rhythm that can be treated by means of defibrillation. In most emergency medical systems (EMS) time to defibrillation is too long and survival averages 10 %.However, when laymen operated Automated External Defibrillators (AEDs) are used within the first minutes, 7 out of 10 may survive. The aim of "The Scandinavian AED and Mobile Bystander Activation" (SAMBA) trial is to evaluate if a Mobile Phone Positioning system and a smartphone application will increase the proportions of patients with an attached Automated External Defibrillator (AED) before arrival of the Emergence Medical System (EMS). Mobile phone technology and a smartphone application will be used identify and recruit nearby CPR-trained lay people and automated external defibrillators (AEDs) to patients suffering out-of-hospital cardiac arrest (OHCA). The system is currently running in Stockholm Sweden and in the Gothenburg region.

Full Title of Study: “The Scandinavian AED and Mobile Bystander Activation Trial – a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Care Provider, Investigator)
  • Study Primary Completion Date: October 20, 2020

Detailed Description

Early defibrillation in out-of-hospital cardiac arrest is associated with high survival rates. If the operator at the dispatch center suspects an out-of-hospital cardiac arrest he or she will activate the mobile positioning system (MPS) wich is integrated in the operators computer environment. After activation, the system will locate all CPR-trained volunteers nearby the suspected OHCA. By computer based 1:1 randomization lay volunteers will be alerted and dispatched in 50 % of all suspected OHCAs in where the system is triggered by the dispatchers. In the intervention group, the activation of the system is supposed to result in lay volunteers to be alerted and directed to fetch the nearest AED and commence early defibrillation. Dependent on geographical and logistical circumstances, at a minimum one lay volunteer or more will be alerted to provide bystander CPR only. In the control group the MPS will be activated and lay responders will be dispatched to suspected OHCA to perform CPR only. In both groups the ordinary EMS services are dispatched in a regular fashion.

Interventions

  • Device: Layperson allocated to start CPR and fetch nearest AED
    • Dispatching laypersons to fetch an AED and start CPR in out-of-hospital cardiac arrest
  • Device: Layperson allocated to start CPR
    • Dispatching laypersons to start CPR out-of-hospital cardiac arrest

Arms, Groups and Cohorts

  • Experimental: Layperson allocated to fetch an AED and start CPR
    • In the intervention group mobile lifesavers will be directed to fetch the nearest AED and then attach it to the victim of OHCA. At least 1 volunteer will be directed to start CPR only
  • Active Comparator: Layperson allocated to start CPR
    • In the control group all mobile lifesavers will be directed to the patient to start CPR.

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of patients with AED attached prior to arrival of EMS, fire or police services.
    • Time Frame: 12 months
    • Attached public AED before arrival of EMS or first responders (fire, police).

Secondary Measures

  • Proportion of patients with bystander CPR prior to arrival of EMS, fire or police services.
    • Time Frame: 12 months
    • Any bystander CPR before arrival of EMS, fire or police services
  • Proportion of patients defibrillated before arrival of EMS, fire or police services arrival.
    • Time Frame: 12 months
    • Use of (defibrillation) AED before EMS (ambulance fire and police) arrival.

Participating in This Clinical Trial

Inclusion Criteria

  • All EMS-treated OHCAs within the Stockholm County, Copenhagen and VGR area and in whom the mobile positioning system is activated at the emergency dispatch center Exclusion Criteria:

  • Crew witnessed OHCAs – Patients <8 years of age – OHCAs due to trauma, intoxication, or suicide – OHCAs not treated by the EMS due to ethical reasons or obvious signs of death. – No OHCA cases

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karolinska Institutet
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jacob Hollenberg, Associate Professor – Karolinska Institutet
  • Overall Official(s)
    • Mattias Ringh, MD, PhD, Principal Investigator, Karolinska Institutet
    • Jacob Hollenberg, MD, PhD, Principal Investigator, Karolinska Institutet

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