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

Sponsor

Emergency Medical Services, Capital Region, Denmark (Other)

Overall Status

Recruiting

CT.gov ID

NCT04446585

Collaborator

TrygFonden, Denmark (Industry), Zoll Medical Corporation (Industry), Danish Heart Foundation (Other)

260

Enrollment

Location

Arms

62.1

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Out-Of-Hospital Cardiac Arrest	Device: Automated External Defibrillator (AED) Other: Training in cardiopulmonary resuscitation and AED use Other: Activation of citizen responders	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 29, 2020

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Bystander defibrillation [Up to five years after implementation of the intervention]
Proportion of bystander defibrillation of witnessed cardiac arrests

Secondary Outcome Measures

30-day survival [30 days after date of cardiac arrest]
Proportion of patients alive 30 days after date of cardiac arrest

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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