Cardiac Arrest in Residential Areas With Mobile First-responder Activation

NCT ID: NCT04446585

Last Updated: 2023-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2027-01-31

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.

Conditions

Out-Of-Hospital Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Automated External Defibrillator (AED)

Intervention Type: DEVICE

Deployment of AEDs

Training in cardiopulmonary resuscitation and AED use

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

Automated External Defibrillator (AED)

Deployment of AEDs

Intervention Type: DEVICE

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

Intervention Type: OTHER

Activation of citizen responders

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TrygFonden, Denmark

INDUSTRY

Sponsor Role: collaborator

Zoll Medical Corporation

INDUSTRY

Sponsor Role: collaborator

Danish Heart Foundation

OTHER

Sponsor Role: collaborator

Emergency Medical Services, Capital Region, Denmark

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fredrik Folke

M.D., PhD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fredrik Folke, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

EMS Copenhagen

Carolina M Hansen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

EMS Copenhagen

Locations

Emergency Medical Services Copenhagen

Ballerup Municipality, The Capital Region, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Anne J Jørgensen, MD

Role: CONTACT

anne.juul.joergensen.02@regionh.dk

+45 60 62 91 14

Fredrik Folke, MD, PhD

Role: CONTACT

ff@heart.dk

+45 28 18 29 78

Facility Contacts

Anne J Jørgensen, MD

Role: primary

anne.juul.joergensen.02@regionh.dk

+45 60 62 91 14

References

Juul Grabmayr A, Malta Hansen C, Bo N, Sheikh AP, Hassager C, Ersboll A, Kjaergaard J, Lippert F, Tjornhoj-Thomsen T, Gislason G, Torp-Pedersen C, Folke F. Community intervention to improve defibrillation before ambulance arrival in residential neighbourhoods with a high risk of out-of-hospital cardiac arrest: study protocol of a cluster-randomised trial (the CARAMBA trial). BMJ Open. 2023 Oct 10;13(10):e073541. doi: 10.1136/bmjopen-2023-073541.

Reference Type: DERIVED

PMID: 37816557 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

111

Identifier Type: -

Identifier Source: org_study_id