The Scandinavian AED and Mobile Bystander Activation Trial

NCT ID: NCT02992873

Last Updated: 2020-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 815 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-10-20

Brief Summary

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Layperson allocated to start CPR and fetch nearest AED

Intervention Type: DEVICE

Dispatching laypersons to fetch an AED and start CPR in out-of-hospital cardiac arrest

Layperson allocated to start CPR

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

Group Type: ACTIVE_COMPARATOR

Layperson allocated to start CPR

Intervention Type: DEVICE

Dispatching laypersons to start CPR out-of-hospital cardiac arrest

Interventions

Layperson allocated to start CPR and fetch nearest AED

Dispatching laypersons to fetch an AED and start CPR in out-of-hospital cardiac arrest

Intervention Type: DEVICE

Layperson allocated to start CPR

Dispatching laypersons to start CPR out-of-hospital cardiac arrest

Intervention Type: DEVICE

Other Intervention Names

Dispatch to start CPR and fetch nearest AED; Dispatch to start CPR

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Jacob Hollenberg

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mattias Ringh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Jacob Hollenberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Västra Götaland

Gothenburg, , Sweden

Stockholm, Sweden

Stockholm, , Sweden

Countries

Sweden

References

Berglund E, Hollenberg J, Jonsson M, Svensson L, Claesson A, Nord A, Nordberg P, Forsberg S, Rosenqvist M, Lundgren P, Hogstedt A, Riva G, Ringh M. Effect of Smartphone Dispatch of Volunteer Responders on Automated External Defibrillators and Out-of-Hospital Cardiac Arrests: The SAMBA Randomized Clinical Trial. JAMA Cardiol. 2023 Jan 1;8(1):81-88. doi: 10.1001/jamacardio.2022.4362.

Reference Type: DERIVED

PMID: 36449309 (View on PubMed)

Other Identifiers

NCT2

Identifier Type: -

Identifier Source: org_study_id