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The Scandinavian AED and Mobile Bystander Activation Trial (SAMBA)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Layperson allocated to start CPR and fetch nearest AED
Layperson allocated to start CPR
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out-Of-Hospital Cardiac Arrest

Eligibility Criteria

8 Years - 120 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Västra Götaland
  • Stockholm, Sweden

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Layperson allocated to fetch an AED and start CPR

Layperson allocated to start CPR

Arm Description

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

In the control group all mobile lifesavers will be directed to the patient to start CPR.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
Proportion of patients defibrillated before arrival of EMS, fire or police services arrival.
Use of (defibrillation) AED before EMS (ambulance fire and police) arrival.

Full Information

First Posted
December 12, 2016
Last Updated
November 23, 2020
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02992873
Brief Title
The Scandinavian AED and Mobile Bystander Activation Trial
Acronym
SAMBA
Official Title
The Scandinavian AED and Mobile Bystander Activation Trial - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
October 20, 2020 (Actual)
Study Completion Date
October 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-Of-Hospital Cardiac Arrest, Cardiac Arrest, Sudden

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
815 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Layperson allocated to fetch an AED and start CPR
Arm Type
Experimental
Arm Description
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
Arm Title
Layperson allocated to start CPR
Arm Type
Active Comparator
Arm Description
In the control group all mobile lifesavers will be directed to the patient to start CPR.
Intervention Type
Device
Intervention Name(s)
Layperson allocated to start CPR and fetch nearest AED
Other Intervention Name(s)
Dispatch to start CPR and fetch nearest AED
Intervention Description
Dispatching laypersons to fetch an AED and start CPR in out-of-hospital cardiac arrest
Intervention Type
Device
Intervention Name(s)
Layperson allocated to start CPR
Other Intervention Name(s)
Dispatch to start CPR
Intervention Description
Dispatching laypersons to start CPR out-of-hospital cardiac arrest
Primary Outcome Measure Information:
Title
Proportion of patients with AED attached prior to arrival of EMS, fire or police services.
Description
Attached public AED before arrival of EMS or first responders (fire, police).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Proportion of patients with bystander CPR prior to arrival of EMS, fire or police services.
Description
Any bystander CPR before arrival of EMS, fire or police services
Time Frame
12 months
Title
Proportion of patients defibrillated before arrival of EMS, fire or police services arrival.
Description
Use of (defibrillation) AED before EMS (ambulance fire and police) arrival.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Adverse events prehospital
Description
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.
Time Frame
12 months
Title
Proportion of CRP by mobile phone dispatched lay volunteers. Both study groups combined.
Description
Additional (total) effect of mobile phone dispatched lay volunteers in both study groups (observational)
Time Frame
up to 12 months
Title
Adverse advents in relation to SMS -alerts, AED use and lay responders
Description
Adverse events concerning the dispatch of lay volunteers
Time Frame
12 months
Title
Proportion of AED attachment prior to the EMS by mobile phone dispatched lay volunteers. Both study groups combined.
Description
Additional (total) effect of mobile phone dispatched lay volunteers in both study groups (observational)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mattias Ringh, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacob Hollenberg, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Västra Götaland
City
Gothenburg
Country
Sweden
Facility Name
Stockholm, Sweden
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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The Scandinavian AED and Mobile Bystander Activation Trial

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