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Cardiac Arrest in Residential Areas With Mobile First-responder Activation

A Cluster Randomized Clinical Trial of Strategic AED Deployment in High-risk Residential Areas Combined With Activation of Local Residents

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04446585
Acronym
CARAMBA
Enrollment
260
Registered
2020-06-25
Start date
2021-12-01
Completion date
2027-01-31
Last updated
2023-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

Suddan cardiac arrest, Heart Arrest, Heart Diseases, Cardiovascular Diseases

Brief 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. 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.

Interventions

DEVICEAutomated External Defibrillator (AED)

Deployment of AEDs

OTHERTraining in cardiopulmonary resuscitation and AED use

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

OTHERActivation of citizen responders

Citizen responders will be activated in case of suspected cardiac arrest through the heart runner app.

Sponsors

TrygFonden, Denmark
CollaboratorINDUSTRY
Zoll Medical Corporation
CollaboratorINDUSTRY
Danish Heart Foundation
CollaboratorOTHER
Emergency Medical Services, Capital Region, Denmark
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Due to the nature of the study, treatment allocation is not masked to rescuers or patients. The steering committee will, during the study, receive information on total numbers of arrests and overall success of providing defibrillation. The steering committee will not receive information on whether defibrillation took place in areas allocated to intervention or no intervention. Only the safety committee will have access to all information.

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Bystander defibrillationUp to five years after implementation of the interventionProportion of bystander defibrillation of witnessed cardiac arrests

Secondary

MeasureTime frameDescription
30-day survival30 days after date of cardiac arrestProportion of patients alive 30 days after date of cardiac arrest

Countries

Denmark

Contacts

Primary ContactAnne J Jørgensen, MD
anne.juul.joergensen.02@regionh.dk+45 60 62 91 14
Backup ContactFredrik Folke, MD, PhD
ff@heart.dk+45 28 18 29 78

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026