Cardiac Arrest in Residential Areas With Mobile First-responder Activation

NCT04446585 | Recruiting DMC FDA Device

• 1 other identifier: 111
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

Suddan cardiac arrest; Heart Arrest; Heart Diseases; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Bystander defibrillation

  Proportion of bystander defibrillation of witnessed cardiac arrests

  Up to five years after implementation of the intervention

Secondary Outcomes (1)

• 30-day survival

  30 days after date of cardiac arrest

Study Arms (2)

Control sites

NO INTERVENTION

* 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.

Intervention sites

EXPERIMENTAL

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); Other: Training in cardiopulmonary resuscitation and AED use; Other: Activation of citizen responders

Interventions

Automated External Defibrillator (AED) DEVICE

Deployment of AEDs

Intervention sites

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

Intervention sites

Activation of citizen responders OTHER

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

Intervention sites

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Emergency Medical Services, Capital Region, Denmark: lead
• TrygFonden, Denmark: collaborator
• Zoll Medical Corporation: collaborator
• Danish Heart Foundation: collaborator

Study Sites (1)

Emergency Medical Services Copenhagen

Ballerup Municipality, The Capital Region, 2750, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 37816557 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Heart Arrest; Heart Diseases; Cardiovascular Diseases

Interventions

Defibrillators; Cardiopulmonary Resuscitation

Intervention Hierarchy (Ancestors)

Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Resuscitation; Emergency Treatment; Therapeutics

Study Officials

• Fredrik Folke, MD, PhD

  EMS Copenhagen

  PRINCIPAL INVESTIGATOR

• Carolina M Hansen, MD, PhD

  EMS Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne J Jørgensen, MD

CONTACT

+45 60 62 91 14; anne.juul.joergensen.02@regionh.dk

Fredrik Folke, MD, PhD

CONTACT

+45 28 18 29 78; ff@heart.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD, Professor

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 25, 2020
• Study Start: December 1, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)