Out-Of-Hospital Cardiac ArrestCARAMBANCT04446585
Cardiac Arrest in Residential Areas With Mobile First-responder Activation
A study testing Automated External Defibrillator (AED), Training in cardiopulmonary resuscitation and AED use and Activation of citizen responders in people with Out-Of-Hospital Cardiac Arrest, run by Emergency Medical Services, Capital Region, Denmark at 1 site in Denmark.
Trial summary
The study aims to increase proportions of bystander defibrillation during out-of-hospital cardiac arrest (hereof referred to as cardiac arrest) in residential areas with a high density of cardiac arrests. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Automated External Defibrillator (AED), Training in cardiopulmonary resuscitation and AED use and Activation of citizen responders
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2021to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All witnessed cardiac arrests recognized registered in the Danish Cardiac Arrest Registry occurring within the study sites. This excludes non witnessed cardiac arrests.
- Witnessed cardiac arrest
- Non-traumatic etiology, this excludes intoxication, drowning or suicide.
Who cannot join
- Cardiac arrest occurring in a nursing home
- Cardiac arrest not treated by the EMS due to ethical reasons or obvious signs of death
- Not true cardiac arrest (suspected, but not verified)
- Cardiac arrests witnessed by the emergency medical personnel
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Emergency Medical Services Copenhagen
Ballerup Municipality, The Capital Region, 2750
Anne J Jørgensen, MD, +45 60 62 91 14, anne.juul.joergensen.02@regionh.dk
Fredrik Folke, MD, PhD
About this study
Official title: A Cluster Randomized Clinical Trial of Strategic AED Deployment in High-risk Residential Areas Combined With Activation of Local Residents
The study aims to increase proportions of bystander defibrillation during out-of-hospital cardiac arrest (hereof referred to as cardiac arrest) in residential areas with a high density of cardiac arrests. The intervention consists of Automated External Defibrillators (AEDs) and residents' involvement in resuscitation through training and enrollment as citizen responders.
Read the detailed description
Survival decreases by 10% for every minute that passes after a cardiac arrest until defibrillation. Despite an increasing number of available AEDs, survival and defibrillation rates in residential areas remain poor. Efforts to increase bystander defibrillation has the potential to improve survival. Through the strategic deployment of AEDs, training, and recruitment of residents as citizen responders, we aim to improve proportions of bystander defibrillation and 30-day survival in densely populated residential areas with a high density of cardiac arrests.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Automated External Defibrillator (AED), Training in cardiopulmonary resuscitation and AED use, Activation of citizen responders
- Keywords
- Suddan cardiac arrest, Heart Arrest, Heart Diseases, Cardiovascular Diseases
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated External Defibrillator (AED)Device
Deployment of AEDs
Training in cardiopulmonary resuscitation and AED useOther
Residents will undergo 30-minute courses at study start and if needed during the trial period. During the course they will also be recruited as citizen responders
Activation of citizen respondersOther
Citizen responders will be activated in case of suspected cardiac arrest through the heart runner app.
| Study group | Role | What they receive |
|---|---|---|
| Control sites | No intervention | * For all 1-1-2 calls with suspected cardiac arrest to the emergency dispatch center will activate a two-tiered response consisting of dispatch of an ambulance with an emergency medical technician, a physician-staffed mobile emergency care unit, and citizen first responders through the Heart Runner app. * The medical dispatcher offers telephone assisted cardiopulmonary resuscitation (CPR) to bystanders. Furthermore, if more than two bystanders are present and an AED is accessible within 1½ minute travel distance (depending on the type of terrain), then one bystander is guided to localize and retrieve the AED. |
| Intervention sites | Experimental | As a supplement to the standard care as described in the control arm, the following will be supplied:
* Strategical deployment of AEDs with 24:7 availability and 1½ minute walking distance to every residence within the area. The AEDs will be registered with the AED network and thus linked to the emergency dispatch center.
* The emergency dispatch center will retrieve data from used AEDs.
* For each interventional area, approximately 120 residents will receive a course in CPR and AED use and subsequently be recruited as citizen responders so that they can be activated through the HeartRunner app in case of a nearby cardiac arrest. Receives: Device: Automated External Defibrillator (AED); Other: Training in cardiopulmonary resuscitation and AED use; Other: Activation of citizen responders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bystander defibrillation
Proportion of bystander defibrillation of witnessed cardiac arrests
Measured: Up to five years after implementation of the intervention
Secondary outcomes (1)
30-day survival
Proportion of patients alive 30 days after date of cardiac arrest
Measured: 30 days after date of cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Dec 2021
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emergency Medical Services, Capital Region, Denmark
- Sponsor type
- Other government
- Collaborators
- TrygFonden, Denmark, Zoll Medical Corporation, Danish Heart Foundation
- Responsible party
- Principal investigator, Fredrik Folke, Emergency Medical Services, Capital Region, Denmark
- Investigators
- Fredrik Folke, MD, PhD, Principal investigator, EMS CopenhagenCarolina M Hansen, MD, PhD, Principal investigator, EMS Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446585
- Sponsor's protocol ID
- 111
- Acronym
- CARAMBA
- Status last verified
- Sep 2023
- First submitted
- 16 Jun 2020
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Juul Grabmayr A, Malta Hansen C, Bo N, Sheikh AP, Hassager C, Ersboll A, Kjaergaard J, Lippert F, Tjornhoj-Thomsen T, Gislason G, Torp-Pedersen C, Folke F. Community intervention to improve defibrillation before ambulance arrival in residential neighbourhoods with a high risk of out-of-hospital cardiac arrest: study protocol of a cluster-randomised trial (the CARAMBA trial). BMJ Open. 2023 Oct 10;13(10):e073541. doi: 10.1136/bmjopen-2023-073541.
PubMed 37816557
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Clinical Trial of Strategic AED Deployment in High-risk Residential Areas Combined With Activation of Local Residents
- ClinicalTrials.gov ID
- NCT04446585
- Acronym / sponsor ID
- CARAMBA / 111
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Suddan cardiac arrest, Heart Arrest, Heart Diseases, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Emergency Medical Services, Capital Region, DenmarkOther government
- Collaborators
- TrygFonden, Denmark, Zoll Medical Corporation, Danish Heart Foundation
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 25 Jun 2020 (actual)
- 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.
The study aims to increase proportions of bystander defibrillation during out-of-hospital cardiac arrest (hereof referred to as cardiac arrest) in residential areas with a high density of cardiac arrests. The intervention consists of Automated External Defibrillators (AEDs) and residents' involvement in resuscitation through training and enrollment as citizen responders.
Detailed description
Survival decreases by 10% for every minute that passes after a cardiac arrest until defibrillation. Despite an increasing number of available AEDs, survival and defibrillation rates in residential areas remain poor. Efforts to increase bystander defibrillation has the potential to improve survival. Through the strategic deployment of AEDs, training, and recruitment of residents as citizen responders, we aim to improve proportions of bystander defibrillation and 30-day survival in densely populated residential areas with a high density of cardiac arrests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control sites | No intervention | –* For all 1-1-2 calls with suspected cardiac arrest to the emergency dispatch center will activate a two-tiered response consisting of dispatch of an ambulance with an emergency medical technician, a physician-staffed mobile emergency care unit, and citizen first responders through the Heart Runner app. * The medical dispatcher offers telephone assisted cardiopulmonary resuscitation (CPR) to bystanders. Furthermore, if more than two bystanders are present and an AED is accessible within 1½ minute travel distance (depending on the type of terrain), then one bystander is guided to localize and retrieve the AED. |
| Intervention sites | Experimental | Device: Automated External Defibrillator (AED), Other: Training in cardiopulmonary resuscitation and AED use, Other: Activation of citizen respondersAs a supplement to the standard care as described in the control arm, the following will be supplied: * Strategical deployment of AEDs with 24:7 availability and 1½ minute walking distance to every residence within the area. The AEDs will be registered with the AED network and thus linked to the emergency dispatch center. * The emergency dispatch center will retrieve data from used AEDs. * For each interventional area, approximately 120 residents will receive a course in CPR and AED use and subsequently be recruited as citizen responders so that they can be activated through the HeartRunner app in case of a nearby cardiac arrest. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All witnessed cardiac arrests recognized registered in the Danish Cardiac Arrest Registry occurring within the study sites. This excludes non witnessed cardiac arrests.
- Witnessed cardiac arrest
- Non-traumatic etiology, this excludes intoxication, drowning or suicide.
Key exclusion criteria (4 listed)
- Cardiac arrest occurring in a nursing home
- Cardiac arrest not treated by the EMS due to ethical reasons or obvious signs of death
- Not true cardiac arrest (suspected, but not verified)
- Cardiac arrests witnessed by the emergency medical personnel
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 |
|---|---|---|
| Automated External Defibrillator (AED)Deployment of AEDs | Device | Intervention sites |
| Training in cardiopulmonary resuscitation and AED useResidents will undergo 30-minute courses at study start and if needed during the trial period. During the course they will also be recruited as citizen responders | Other | Intervention sites |
| Activation of citizen respondersCitizen responders will be activated in case of suspected cardiac arrest through the heart runner app. | Other | Intervention sites |
Primary outcome
Bystander defibrillation
Time frame: Up to five years after implementation of the intervention
Proportion of bystander defibrillation of witnessed cardiac arrests
1 secondary outcome
30-day survival
Time frame: 30 days after date of cardiac arrest
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Derived from this study: PubMed 37816557Juul Grabmayr A, Malta Hansen C, Bo N, Sheikh AP, Hassager C, Ersboll A, Kjaergaard J, Lippert F, Tjornhoj-Thomsen T, Gislason G, Torp-Pedersen C, Folke F. Community intervention to improve defibrillation before ambulance arrival in residential neighbourhoods with a high risk of out-of-hospital cardiac arrest: study protocol of a cluster-randomised trial (the CARAMBA trial). BMJ Open. 2023 Oct 10;13(10):e073541. doi: 10.1136/bmjopen-2023-073541.
- 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.
Fredrik Folke, MD, PhD principal investigator
EMS Copenhagen
Carolina M Hansen, MD, PhD principal investigator
EMS Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated External Defibrillator (AED), Training in cardiopulmonary resuscitation and AED use and Activation of citizen responders in people with Out-Of-Hospital Cardiac Arrest, run by Emergency Medical Services, Capital Region, Denmark at 1 site in Denmark.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne J Jørgensen, MD (+45 60 62 91 14, anne.juul.joergensen.02@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bystander defibrillation (time frame: Up to five years after implementation of the intervention). 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 NCT04446585, 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 15 Sep 2023.