The Scandinavian AED and Mobile Bystander Activation Trial

NCT02992873 | Completed DMC

• 1 other identifier: NCT2
• Study Type: interventional
• Target: 815
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Proportion of patients with bystander CPR prior to arrival of EMS, fire or police services.

  12 months

• Proportion of patients defibrillated before arrival of EMS, fire or police services arrival.

  12 months

Other Outcomes (4)

• Adverse events prehospital

  12 months

• Proportion of CRP by mobile phone dispatched lay volunteers. Both study groups combined.

  up to 12 months

• Adverse advents in relation to SMS -alerts, AED use and lay responders

  12 months

Study Arms (2)

Layperson allocated to fetch an AED and start CPR

EXPERIMENTAL

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

Layperson allocated to start CPR

ACTIVE COMPARATOR

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

Device: Layperson allocated to start CPR

Interventions

Layperson allocated to start CPR and fetch nearest AED DEVICE

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

Also known as: Dispatch to start CPR and fetch nearest AED

Layperson allocated to fetch an AED and start CPR

Layperson allocated to start CPR DEVICE

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

Also known as: Dispatch to start CPR

Layperson allocated to start CPR

Eligibility Criteria

• Age: 8 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (2)

Västra Götaland

Gothenburg, Sweden

Location

Stockholm, Sweden

Stockholm, Sweden

Location

Related Publications (1)

• Berglund E, Hollenberg J, Jonsson M, Svensson L, Claesson A, Nord A, Nordberg P, Forsberg S, Rosenqvist M, Lundgren P, Hogstedt A, Riva G, Ringh M. Effect of Smartphone Dispatch of Volunteer Responders on Automated External Defibrillators and Out-of-Hospital Cardiac Arrests: The SAMBA Randomized Clinical Trial. JAMA Cardiol. 2023 Jan 1;8(1):81-88. doi: 10.1001/jamacardio.2022.4362.

  PMID: 36449309 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mattias Ringh, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Jacob Hollenberg, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 14, 2016
• Study Start: December 1, 2018
• Primary Completion: October 20, 2020
• Study Completion: October 20, 2020
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)