Cardiac Arrest in Residential Areas With Mobile First-responder Activation (CARAMBA)

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.

Study Overview

• Status: Recruiting
• Conditions: Out-Of-Hospital Cardiac Arrest
• Intervention / Treatment: Device: Automated External Defibrillator (AED); Other: Training in cardiopulmonary resuscitation and AED use; Other: Activation of 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 Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne J Jørgensen, MD; Phone Number: +45 60 62 91 14; Email: anne.juul.joergensen.02@regionh.dk
• Study Contact Backup: Name: Fredrik Folke, MD, PhD; Phone Number: +45 28 18 29 78; Email: ff@heart.dk

Study Locations

• Denmark
  • The Capital Region
    • Ballerup, The Capital Region, Denmark, 2750
      • Recruiting
      • Emergency Medical Services Copenhagen
      • Principal Investigator: Fredrik Folke, MD, PhD
      • Contact: Anne J Jørgensen, MD; Phone Number: +45 60 62 91 14; Email: anne.juul.joergensen.02@regionh.dk
      • Principal Investigator: Carolina M Hansen, MD, PhD
      • Sub-Investigator: Anne J Jørgensen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control sites; 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.
Experimental: Intervention sites; 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.	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; Other: Activation of citizen responders; Citizen responders will be activated in case of suspected cardiac arrest through the heart runner app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bystander defibrillation	Proportion of bystander defibrillation of witnessed cardiac arrests	Up to five years after implementation of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day survival	Proportion of patients alive 30 days after date of cardiac arrest	30 days after date of cardiac arrest

Collaborators and Investigators

• Sponsor: Emergency Medical Services, Capital Region, Denmark
• Collaborators: TrygFonden, Denmark; Danish Heart Foundation; Zoll Medical Corporation
• Investigators: Principal Investigator: Fredrik Folke, MD, PhD, EMS Copenhagen; Principal Investigator: Carolina M Hansen, MD, PhD, EMS Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Heart Diseases; Heart Arrest; Suddan cardiac arrest
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes