The Scandinavian AED and Mobile Bystander Activation Trial

Out-Of-Hospital Cardiac Arrest Clinical Trial

— SAMBA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992873
• Other study ID #: NCT2
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: October 20, 2020

Study information

• Verified date: November 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 815
• Est. completion date: October 20, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest, Sudden
• Death, Sudden, Cardiac
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

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
• Layperson allocated to start CPR
Dispatching laypersons to start CPR out-of-hospital cardiac arrest

Locations

Country	Name	City	State
Sweden	Västra Götaland	Gothenburg
Sweden	Stockholm, Sweden	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Adverse advents in relation to SMS -alerts, AED use and lay responders	Adverse events concerning the dispatch of lay volunteers	12 months
Other	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
Primary	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	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
Secondary	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