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

Primary Purpose

Out-Of-Hospital Cardiac Arrest

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Automated External Defibrillator (AED)
Training in cardiopulmonary resuscitation and AED use
Activation of citizen responders
Sponsored by
Emergency Medical Services, Capital Region, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out-Of-Hospital Cardiac Arrest focused on measuring Suddan cardiac arrest, Heart Arrest, Heart Diseases, Cardiovascular Diseases

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Emergency Medical Services CopenhagenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control sites

Intervention sites

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Bystander defibrillation
Proportion of bystander defibrillation of witnessed cardiac arrests

Secondary Outcome Measures

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

Full Information

First Posted
June 16, 2020
Last Updated
September 14, 2023
Sponsor
Emergency Medical Services, Capital Region, Denmark
Collaborators
TrygFonden, Denmark, Zoll Medical Corporation, Danish Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04446585
Brief Title
Cardiac Arrest in Residential Areas With Mobile First-responder Activation
Acronym
CARAMBA
Official Title
A Cluster Randomized Clinical Trial of Strategic AED Deployment in High-risk Residential Areas Combined With Activation of Local Residents
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emergency Medical Services, Capital Region, Denmark
Collaborators
TrygFonden, Denmark, Zoll Medical Corporation, Danish Heart Foundation

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-Of-Hospital Cardiac Arrest
Keywords
Suddan cardiac arrest, Heart Arrest, Heart Diseases, Cardiovascular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control sites
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention sites
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Automated External Defibrillator (AED)
Intervention Description
Deployment of AEDs
Intervention Type
Other
Intervention Name(s)
Training in cardiopulmonary resuscitation and AED use
Intervention Description
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
Intervention Name(s)
Activation of citizen responders
Intervention Description
Citizen responders will be activated in case of suspected cardiac arrest through the heart runner app.
Primary Outcome Measure Information:
Title
Bystander defibrillation
Description
Proportion of bystander defibrillation of witnessed cardiac arrests
Time Frame
Up to five years after implementation of the intervention
Secondary Outcome Measure Information:
Title
30-day survival
Description
Proportion of patients alive 30 days after date of cardiac arrest
Time Frame
30 days after date of cardiac arrest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne J Jørgensen, MD
Phone
+45 60 62 91 14
Email
anne.juul.joergensen.02@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Fredrik Folke, MD, PhD
Phone
+45 28 18 29 78
Email
ff@heart.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrik Folke, MD, PhD
Organizational Affiliation
EMS Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carolina M Hansen, MD, PhD
Organizational Affiliation
EMS Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Medical Services Copenhagen
City
Ballerup
State/Province
The Capital Region
ZIP/Postal Code
2750
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne J Jørgensen, MD
Phone
+45 60 62 91 14
Email
anne.juul.joergensen.02@regionh.dk
First Name & Middle Initial & Last Name & Degree
Fredrik Folke, MD, PhD
First Name & Middle Initial & Last Name & Degree
Carolina M Hansen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Anne J Jørgensen, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cardiac Arrest in Residential Areas With Mobile First-responder Activation

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