The Impact of First Responder Intervention on Survival in Out-of-Hospital Cardiac Arrest in Emilia-Romagna Region (FIRSST-RER)
FIRSST-RER Study: The Impact of First Responder Intervention on Survival in Out-of-Hospital Cardiac Arrest in Emilia-Romagna
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be contacted to provide consent and additional follow-up information; participation is voluntary, and consent can be withdrawn at any time.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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Lorenzo Gamberini, Medical Doctor
- Número de telefone: +390516478215
- E-mail: lorenzo.gamberini@ausl.bologna.it
Locais de estudo
-
-
Emilia-Romagna
-
Bologna, Emilia-Romagna, Itália
- Carlo Alberto Pizzardi Major Hospital
-
Contato:
- Lorenzo Gamberini, Medical Doctor
- Número de telefone: +390516378215
- E-mail: lorenzo.gamberini@ausl.bologna.it
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Age <18 years
- Cardiac arrest not confirmed after EMS assessment
- Cases with return code <2 (misclassified as cardiac arrest)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
First Responder Intervention
Patients with OHCA in whom at least one First Responder accepted the mission via DAE RespondER
|
|
No First Responder Intervention
Patients with OHCA in whom no First Responder accepted the mission
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Survival at 30 Days After Out-of-Hospital Cardiac Arrest
Prazo: 30 days after the index event
|
All-cause survival at 30 days after the index out-of-hospital cardiac arrest event, assessed using regional health administrative databases and follow-up data.
|
30 days after the index event
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Survival at 6 Months After Out-of-Hospital Cardiac Arrest
Prazo: 6 months after the index event
|
All-cause survival at 6 months after the index out-of-hospital cardiac arrest event, assessed using regional health administrative databases and follow-up data.
|
6 months after the index event
|
|
Survival at 1 Year After Out-of-Hospital Cardiac Arrest
Prazo: 1 year after the index event
|
All-cause survival at 1 year after the index out-of-hospital cardiac arrest event, assessed using regional health administrative databases and follow-up data.
|
1 year after the index event
|
|
Favourable Neurological Outcome at Follow-Up
Prazo: Up to 1 year after the index event
|
Neurological outcome assessed at the longest available follow-up using the Cerebral Performance Category (CPC) scale.
Favourable outcome is defined as CPC 1-2, and unfavourable outcome as CPC 3-5.
|
Up to 1 year after the index event
|
|
Survival at 30 Days According to First Responder Training Level
Prazo: 30 days after the index event
|
Comparison of 30-day survival between patients receiving intervention from trained First Responders (BLS/ALS certified) and those receiving intervention from untrained First Responders.
|
30 days after the index event
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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, Scholz SS, Shahriari P, Snobelen P, Stieglis R, Strickmann B, Tan HL, Thies KC, Vercammen S, Wetsch WA, Greif R. Defining the terminology of first responders alerted for out-of-hospital cardiac arrest by medical dispatch centres: An international consensus study on nomenclature. Resusc Plus. 2025 Feb 20;22:100912. doi: 10.1016/j.resplu.2025.100912. eCollection 2025 Mar.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 116-2026-OSS-AUSLBO
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Individual participant data (IPD) that underlie the results reported in this study, after de-identification, will be made available to researchers upon reasonable request.
Data will be available beginning 6 months and ending 5 years following publication of the study results.
Researchers who provide a methodologically sound proposal will be eligible to access the data for purposes of achieving the aims of the approved proposal.
Proposals should be directed to the corresponding investigator. Data will be shared following approval by the study steering committee and in compliance with applicable data protection regulations (GDPR).
Data will be provided in a de-identified format, and a data sharing agreement will be required.
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Access to de-identified individual participant data and supporting documents will be granted to researchers who provide a methodologically sound research proposal.
Requests will be reviewed by the study steering committee. Data will be shared following approval and in compliance with applicable data protection regulations (GDPR).
A data sharing agreement will be required. Data will be provided in a secure format, and access may be restricted to ensure confidentiality and appropriate use.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Parada Cardíaca (PC)
-
Assiut UniversityAinda não está recrutandoCardiac CT TOF
-
Liu ChengAtivo, não recrutando
-
Steward St. Elizabeth's Medical Center of Boston...ConcluídoPróstata CAEstados Unidos
-
University College, LondonLucida Medical LtdAinda não está recrutando
-
Stanford UniversityRecrutamentoDoença de Deposição de Gadolínio | Ca-DTPAEstados Unidos
-
Yang LiuConcluídoInstabilidade crônica do tornozelo, CAChina
-
Yang LiuConcluídoInstabilidade crônica do tornozelo, CA | Aptidão Física BásicaChina
-
British Columbia Cancer AgencyRecrutamento
-
Akiva MintzRecrutamento
-
Rubedo Life Sciences, Inc.Recrutamento