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NCT Number: NCT04446585

Cardiac Arrest in Residential Areas With Mobile First-responder Activation

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.

Recruiting

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Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Medical Services Copenhagen

Ballerup Municipality, The Capital Region, 2750, Denmark

Location status: Recruiting

Location contact

Anne J Jørgensen, MD

CONTACT

[email protected]

+45 60 62 91 14

Anne J Jørgensen, MD

SUB_INVESTIGATOR

Carolina M Hansen, MD, PhD

PRINCIPAL_INVESTIGATOR

Fredrik Folke, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated External Defibrillator (AED)

Device

Deployment of AEDs

Training in cardiopulmonary resuscitation and AED use

Other

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 responders

Other

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

Primary outcomes

  1. Bystander defibrillation

    Time frame: Up to five years after implementation of the intervention

    Proportion of bystander defibrillation of witnessed cardiac arrests

Secondary outcomes

  1. 30-day survival

    Time frame: 30 days after date of cardiac arrest

    Proportion of patients alive 30 days after date of cardiac arrest

Study contacts

Contact information is provided by the study sponsor or research team.

Anne J Jørgensen, MD

CONTACT

[email protected]

+45 60 62 91 14

Fredrik Folke, MD, PhD

CONTACT

[email protected]

+45 28 18 29 78

Sponsors and collaborators

Lead sponsor

Emergency Medical Services, Capital Region, Denmark

Other Gov

Collaborators

  • Danish Heart Foundation
  • TrygFonden, Denmark
  • Zoll Medical Corporation

Registry information

Official study title

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

Acronym: CARAMBA

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2020
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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