The Scandinavian AED and Mobile Bystander Activation Trial (SAMBA)

The Scandinavian AED and Mobile Bystander Activation Trial - a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Out-Of-Hospital Cardiac Arrest; Cardiac Arrest, Sudden
• Intervention / Treatment: Device: Layperson allocated to start CPR and fetch nearest AED; Device: Layperson allocated to start CPR

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.

• Study Type: Interventional
• Enrollment (Actual): 815
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Vastra Gotaland
  • Stockholm, Sweden
    • Stockholm, Sweden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 120 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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; Other Names: Dispatch to start CPR and fetch nearest AED
Active Comparator: Layperson allocated to start CPR; In the control group all mobile lifesavers will be directed to the patient to start CPR.	Device: Layperson allocated to start CPR; Dispatching laypersons to start CPR out-of-hospital cardiac arrest; Other Names: Dispatch to start CPR

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events prehospital	All adverse events reported at a prehospital stage will be collected and presented as minor or major events related to lay persons participating as mobile phone dispatched rescuers events related to patients. Minor events are negative safety events with the potential to harm the lay rescuer or patient such as technical malfunction or dispatcher related communication failure. Major events are negative events that actually harms the lay rescuer or OHCA patient due to system malfunction, such as unsafe scene or violation of integrity.	12 months
Proportion of CRP by mobile phone dispatched lay volunteers. Both study groups combined.	Additional (total) effect of mobile phone dispatched lay volunteers in both study groups (observational)	up to 12 months
Adverse advents in relation to SMS -alerts, AED use and lay responders	Adverse events concerning the dispatch of lay volunteers	12 months
Proportion of AED attachment prior to the EMS by mobile phone dispatched lay volunteers. Both study groups combined.	Additional (total) effect of mobile phone dispatched lay volunteers in both study groups (observational)	12 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Jacob Hollenberg, MD, PhD, Karolinska Institutet; Principal Investigator: Mattias Ringh, MD, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): October 20, 2020
• Study Completion (Actual): October 20, 2020

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (Estimate): December 14, 2016

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Heart Arrest; Out-of-Hospital Cardiac Arrest; Death, Sudden, Cardiac
• Other Study ID Numbers: NCT2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No