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NCT Number: NCT02992873

The Scandinavian AED and Mobile Bystander Activation 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.

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Key information

Conditions

Out-Of-Hospital Cardiac Arrest Cardiac Arrest, Sudden Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

8 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Västra Götaland, Gothenburg, Sweden

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Layperson allocated to start CPR and fetch nearest AED

Device

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

Layperson allocated to start CPR

Device

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

Other names: Dispatch to start CPR

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

Other outcomes

  1. Adverse events prehospital

    Time frame: 12 months

    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.

  2. Proportion of CRP by mobile phone dispatched lay volunteers. Both study groups combined.

    Time frame: up to 12 months

    Additional (total) effect of mobile phone dispatched lay volunteers in both study groups (observational)

  3. Adverse advents in relation to SMS -alerts, AED use and lay responders

    Time frame: 12 months

    Adverse events concerning the dispatch of lay volunteers

  4. Proportion of AED attachment prior to the EMS by mobile phone dispatched lay volunteers. Both study groups combined.

    Time frame: 12 months

    Additional (total) effect of mobile phone dispatched lay volunteers in both study groups (observational)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: SAMBA

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 14, 2016
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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