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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
Sponsor:
Information provided by (Responsible Party):
Jacob Hollenberg, Karolinska Institutet

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.


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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 490 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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 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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Mattias Ringh, MD, PhD +46-70-7741878 mattias.ringh@ki.se
Contact: Ellinor Berglund, RN +46723129080 ellinor.berglund@ki.se

Locations
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Sweden
Västra Götaland Recruiting
Gothenburg, Sweden
Stockholm, Sweden Recruiting
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Mattias Ringh, MD, PhD Karolinska Institutet
Principal Investigator: Jacob Hollenberg, MD, PhD Karolinska Institutet
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Responsible Party: Jacob Hollenberg, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02992873    
Other Study ID Numbers: NCT2
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Death
Pathologic Processes