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The Scandinavian AED and Mobile Bystander Activation Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02992873
Acronym
SAMBA
Enrollment
815
Registered
2016-12-14
Start date
2018-12-01
Completion date
2020-10-20
Last updated
2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICELayperson allocated to start CPR and fetch nearest AED

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

DEVICELayperson allocated to start CPR

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

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
8 Years to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with AED attached prior to arrival of EMS, fire or police services.12 monthsAttached public AED before arrival of EMS or first responders (fire, police).

Secondary

MeasureTime frameDescription
Proportion of patients with bystander CPR prior to arrival of EMS, fire or police services.12 monthsAny bystander CPR before arrival of EMS, fire or police services
Proportion of patients defibrillated before arrival of EMS, fire or police services arrival.12 monthsUse of (defibrillation) AED before EMS (ambulance fire and police) arrival.

Other

MeasureTime frameDescription
Adverse events prehospital12 monthsAll 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.
Proportion of AED attachment prior to the EMS by mobile phone dispatched lay volunteers. Both study groups combined.12 monthsAdditional (total) effect of mobile phone dispatched lay volunteers in both study groups (observational)
Proportion of CRP by mobile phone dispatched lay volunteers. Both study groups combined.up to 12 monthsAdditional (total) effect of mobile phone dispatched lay volunteers in both study groups (observational)
Adverse advents in relation to SMS -alerts, AED use and lay responders12 monthsAdverse events concerning the dispatch of lay volunteers

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026