The Scandinavian AED and Mobile Bystander Activation Trial (SAMBA)

Karolinska Institute

Status: Completed

Conditions: Cardiac Arrest, Sudden; Out-Of-Hospital Cardiac Arrest

Treatments: Device: Layperson allocated to start CPR; Device: Layperson allocated to start CPR and fetch nearest AED

Study type: Interventional

Funder types: Other

Identifiers

NCT02992873

NCT2

Details and patient eligibility

About

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 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.

Enrollment: 815 patients

Sex: All

Ages: 8 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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815 participants in 2 patient groups

Layperson allocated to fetch an AED and start CPR

Experimental group

Description:

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

Treatment:

Device: Layperson allocated to start CPR and fetch nearest AED

Layperson allocated to start CPR

Active Comparator group

Description:

In the control group all mobile lifesavers will be directed to the patient to start CPR.

Treatment:

Device: Layperson allocated to start CPR