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| Name | Class |
|---|---|
| TrygFonden, Denmark | INDUSTRY |
| Zoll Medical Corporation | INDUSTRY |
| Danish Heart Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control sites | No Intervention |
| |
| Intervention sites | Experimental | As a supplement to the standard care as described in the control arm, the following will be supplied:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated External Defibrillator (AED) | Device | Deployment of AEDs |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bystander defibrillation | Proportion of bystander defibrillation of witnessed cardiac arrests | Up to five years after implementation of the intervention |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Fredrik Folke, MD, PhD | EMS Copenhagen | Principal Investigator |
| Carolina M Hansen, MD, PhD | EMS Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Medical Services Copenhagen | Recruiting | Ballerup Municipality | The Capital Region | 2750 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37816557 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2022 |
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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.
| 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 |
|
| Activation of citizen responders | Other | Citizen responders will be activated in case of suspected cardiac arrest through the heart runner app. |
|
| Aug 23, 2022 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D016887 | Cardiopulmonary Resuscitation |
| ID | Term |
|---|---|
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
| D013812 | Therapeutics |
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