The Scandinavian AED and Mobile Bystander Activation Trial (SAMBA)
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|ClinicalTrials.gov Identifier: NCT02992873|
Recruitment Status : Recruiting
First Posted : December 14, 2016
Last Update Posted : February 5, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Out-Of-Hospital Cardiac Arrest Cardiac Arrest, Sudden||Device: Layperson allocated to start CPR and fetch nearest AED Device: Layperson allocated to start CPR||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||490 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official Title:||The Scandinavian AED and Mobile Bystander Activation Trial - a Randomized Controlled Trial|
|Actual Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||June 2020|
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 Name: 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 Name: Dispatch to start CPR
- 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).
- 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
- 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.
- 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.
- 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)
- Adverse advents in relation to SMS -alerts, AED use and lay responders [ Time Frame: 12 months ]Adverse events concerning the dispatch of lay volunteers
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02992873
|Contact: Mattias Ringh, MD, PhDemail@example.com|
|Contact: Ellinor Berglund, RNfirstname.lastname@example.org|
|Principal Investigator:||Mattias Ringh, MD, PhD||Karolinska Institutet|
|Principal Investigator:||Jacob Hollenberg, MD, PhD||Karolinska Institutet|