Cardiac Arrest in Residential Areas With Mobile First-responder Activation

Out-Of-Hospital Cardiac Arrest Clinical Trial

— CARAMBA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04446585
• Other study ID #: 111
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: January 2027

Study information

• Verified date: September 2023
• Source: Emergency Medical Services, Capital Region, Denmark
• Contact: Anne J Jørgensen, MD
• Phone: +45 60 62 91 14
• Email: anne.juul.joergensen.02[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The intervention consists of Automated External Defibrillators (AEDs) and residents' involvement in resuscitation through training and enrollment as citizen responders.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Device:
• Automated External Defibrillator (AED)
Deployment of AEDs

Other:
• Training 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
• Activation of citizen responders
Citizen responders will be activated in case of suspected cardiac arrest through the heart runner app.

Locations

Country	Name	City	State
Denmark	Emergency Medical Services Copenhagen	Ballerup	The Capital Region

Sponsors (4)

Lead Sponsor	Collaborator
Emergency Medical Services, Capital Region, Denmark	Danish Heart Foundation, TrygFonden, Denmark, Zoll Medical Corporation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bystander defibrillation	Proportion of bystander defibrillation of witnessed cardiac arrests	Up to five years after implementation of the intervention
Secondary	30-day survival	Proportion of patients alive 30 days after date of cardiac arrest	30 days after date of cardiac arrest