The Impact of First Responder Intervention on Survival in Out-of-Hospital Cardiac Arrest in Emilia-Romagna Region

Официальное название

FIRSST-RER Study: The Impact of First Responder Intervention on Survival in Out-of-Hospital Cardiac Arrest in Emilia-Romagna

Обзор

Out-of-hospital cardiac arrest (OHCA) is a life-threatening emergency and one of the leading causes of death worldwide. Survival depends critically on how quickly help arrives and whether cardiopulmonary resuscitation (CPR) and defibrillation are started early. In recent years, many regions in Europe and Italy, including Emilia-Romagna, have introduced systems that alert nearby volunteers, called First Responders (FRs), through smartphone applications (such as DAE RespondER). These individuals can reach the patient before emergency medical services (EMS) and begin life-saving actions. The FIRSST-RER study aims to evaluate whether the intervention of First Responders improves survival in patients with out-of-hospital cardiac arrest in Emilia-Romagna. This is a multicentre observational study involving approximately 5,000 adult patients who experienced cardiac arrest between 2018 and 2025 and were treated by the regional emergency system. The study compares two groups of patients: those who received help from at least one First Responder activated via the app those who did not receive First Responder intervention The main objective is to determine whether First Responders increase survival at 30 days after cardiac arrest. Additional objectives include evaluating: survival at 6 months and 1 year neurological outcomes (brain function recovery) Data for this study are collected from existing healthcare and emergency system databases, including EMS dispatch records, national health data systems, and the DAE RespondER platform. For patients who survive, follow-up information may be collected through medical records or telephone contact. Importantly, this study does not involve any experimental treatments or changes in patient care. It is based entirely on data already collected during routine emergency care, and therefore does not pose additional risks to patients. All data are handled securely and in compliance with privacy regulations. Personal identifiers are replaced with coded information (pseudonymisation), and only authorised researchers can access the data. Patients who are alive may be contacted to provide consent and additional follow-up information; participation is voluntary, and consent can be withdrawn at any time. The results of this study will provide important evidence on the effectiveness of citizen responder systems and may help guide future improvements in emergency response organisation, public health strategies, and training programmes. Ultimately, the goal is to increase survival and improve outcomes for people experiencing cardiac arrest in the community.

Первичные конечные точки

• Survival at 30 Days After Out-of-Hospital Cardiac Arrest [Срок оценки: 30 days after the index event]

Вторичные конечные точки (4)

• Survival at 6 Months After Out-of-Hospital Cardiac Arrest [Срок оценки: 6 months after the index event]
• Survival at 1 Year After Out-of-Hospital Cardiac Arrest [Срок оценки: 1 year after the index event]
• Favourable Neurological Outcome at Follow-Up [Срок оценки: Up to 1 year after the index event]
• Survival at 30 Days According to First Responder Training Level [Срок оценки: 30 days after the index event]

Критерии участия

Критерии включения

• Age ≥18 years
• Confirmed out-of-hospital cardiac arrest (OHCA)
• Emergency medical services activation with Advanced Life Support dispatch (Code Red Advanced Blue)
• OHCA confirmed by return code 2-3-4 and/or NSIS codes (C0208 or C0205)
• Event occurring between 1 January 2018 and 31 December 2025
• Activation of the regional emergency medical system (Emilia-Romagna 118 system)

Критерии исключения

• Age <18 years
• Cardiac arrest not confirmed after EMS assessment
• Cases with return code <2 (misclassified as cardiac arrest)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Carlo Alberto Pizzardi Major Hospital — Bologna

Публикации

• Marks T, Metelmann B, Gamberini L, Metelmann C, Schnaubelt S, Semeraro F, Hansen CM; European Resuscitation Guidelines 2025 Systems Saving Lives Writing Group. Smartphone-based alert of community first responders: A multinational survey to characterise contemporary systems. Resusc Plus. 2025 May 21;24:100988. doi: 10.1016/j.resplu.2025.100988. eCollection 2025 Jul. PMID 40524974
• Gamberini L, Del Giudice D, Tartaglione M, Allegri D, Coniglio C, Pastori A, Gordini G, Semeraro F; Collaborators. Logistic and cognitive-emotional barriers experienced by first responders when alarmed to get dispatched to out-of-hospital cardiac arrest events: a region-wide survey. Intern Emerg Med. 2024 Apr;19(3):813-822. doi: 10.1007/s11739-023-03487-2. Epub 2023 Dec 21. PMID 38123905
• Gamberini L, Del Giudice D, Saltalamacchia S, Taylor B, Sala I, Allegri D, Pastori A, Coniglio C, Gordini G, Semeraro F; Collaborators. Factors associated with the arrival of smartphone-activated first responders before the emergency medical services in Out-of-Hospital cardiac arrest dispatch. Resuscitation. 2023 Apr;185:109746. doi: 10.1016/j.resuscitation.2023.109746. Epub 2023 Feb 21. PMID 36822460
• Metelmann C, Metelmann B, Muller MP, Scquizzato T, Baldi E, Barry T, Bottiger BW, Busch HJ, Caputo ML, Cheskes S, Cresta R, Deakin CD, Degraeuwe E, Doshi AA, Ekkel MM, Elschenbroich D, Fredman D, Gamberini L, Ganter J, Henriksen FL, Jagtenberg C, Jonsson M, Khalemsky M, Kooy TA, Lott C, Marks T, Monsieurs KG, Moens E, Ng WM, Pooth JS, Prasse S, Salcido DD, Scapigliati A, Schittko N, Schnaubelt S, PMID 40123987
• Baldi E, Wnent J, Caputo ML, Haywood KL, Lilja G, Masterson S, Nehme Z, Perkins GD, Rosell-Ortiz F, Stromsoe A, Tjelmeland IBM, Graesner JT. European Resuscitation Council Guidelines 2025 Epidemiology in Resuscitation. Resuscitation. 2025 Oct;215 Suppl 1:110733. doi: 10.1016/j.resuscitation.2025.110733. PMID 41117565
• Semeraro F, Greif R, Bottiger BW, Burkart R, Cimpoesu D, Georgiou M, Yeung J, Lippert F, S Lockey A, Olasveengen TM, Ristagno G, Schlieber J, Schnaubelt S, Scapigliati A, G Monsieurs K. European Resuscitation Council Guidelines 2021: Systems saving lives. Resuscitation. 2021 Apr;161:80-97. doi: 10.1016/j.resuscitation.2021.02.008. Epub 2021 Mar 24. PMID 33773834

Идентификаторы

NCT: NCT07589504 · 116-2026-OSS-AUSLBO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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