Out-Of-Hospital Cardiac ArrestSAMBANCT02992873
The Scandinavian AED and Mobile Bystander Activation Trial
A study testing Layperson allocated to start CPR and fetch nearest AED and Layperson allocated to start CPR in people with Out-Of-Hospital Cardiac Arrest and Cardiac Arrest, Sudden, run by Karolinska Institutet at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 8 to 120 years
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, Cardiac Arrest, Sudden
- What is being tested?
- Layperson allocated to start CPR and fetch nearest AED and Layperson allocated to start CPR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 815 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Dec 2018to 20 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: The Scandinavian AED and Mobile Bystander Activation Trial - a Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Layperson allocated to start CPR and fetch nearest AED, Layperson allocated to start CPR
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Layperson allocated to start CPR and fetch nearest AEDDevice
Also called Dispatch 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 CPRDevice
Also called Dispatch to start CPR
Dispatching laypersons to start CPR out-of-hospital cardiac arrest
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Layperson allocated to start CPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (2)
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
Measured: 12 months
Proportion of patients defibrillated before arrival of EMS, fire or police services arrival.
Use of (defibrillation) AED before EMS (ambulance fire and police) arrival.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start1 Dec 2018
- Primary completion20 Oct 2020
- Study completion20 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 815 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Hollenberg, Karolinska Institutet
- Investigators
- Mattias Ringh, MD, PhD, Principal investigator, Karolinska InstitutetJacob Hollenberg, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992873
- Sponsor's protocol ID
- NCT2
- Acronym
- SAMBA
- Status last verified
- Nov 2020
- First submitted
- 12 Dec 2016
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36449309
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Scandinavian AED and Mobile Bystander Activation Trial - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02992873
- Acronym / sponsor ID
- SAMBA / NCT2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 815 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Layperson allocated to fetch an AED and start CPR | Experimental | Device: Layperson allocated to start CPR and fetch nearest AEDIn 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 |
| Layperson allocated to start CPR | Active comparator | Device: Layperson allocated to start CPRIn the control group all mobile lifesavers will be directed to the patient to start CPR. |
Who may qualify
- Ages
- 8 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Layperson allocated to start CPR and fetch nearest AEDAlso: Dispatch to start CPR and fetch nearest AEDDispatching laypersons to fetch an AED and start CPR in out-of-hospital cardiac arrest | Device | Layperson allocated to fetch an AED and start CPR |
| Layperson allocated to start CPRAlso: Dispatch to start CPRDispatching laypersons to start CPR out-of-hospital cardiac arrest | Device | Layperson allocated to start CPR |
Primary outcome
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).
2 secondary outcomes
Proportion of patients with bystander CPR prior to arrival of EMS, fire or police services.
Time frame: 12 months
Proportion of patients defibrillated before arrival of EMS, fire or police services arrival.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Derived from this study: PubMed 36449309Berglund 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mattias Ringh, MD, PhD principal investigator
Karolinska Institutet
Jacob Hollenberg, MD, PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Layperson allocated to start CPR and fetch nearest AED and Layperson allocated to start CPR in people with Out-Of-Hospital Cardiac Arrest and Cardiac Arrest, Sudden, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with AED attached prior to arrival of EMS, fire or police services. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02992873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.