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

NCT07589504 | Not Yet Recruiting DMC

• 1 other identifier: 116-2026-OSS-AUSLBO
• Study Type: observational
• Target: 5,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Arrest (CA)

Keywords

first responder; out of hospital cardiac arrest; survival

Outcome Measures

Primary Outcomes (1)

• Survival at 30 Days After Out-of-Hospital Cardiac Arrest

  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

Secondary Outcomes (4)

• Survival at 6 Months After Out-of-Hospital Cardiac Arrest

  6 months after the index event

• Survival at 1 Year After Out-of-Hospital Cardiac Arrest

  1 year after the index event

• Favourable Neurological Outcome at Follow-Up

  Up to 1 year after the index event

• Survival at 30 Days According to First Responder Training Level

  30 days after the index event

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) with confirmed out-of-hospital cardiac arrest managed by the regional emergency medical services (118 system) in Emilia-Romagna between 1 January 2018 and 31 December 2025. Patients are identified through EMS dispatch databases and national health information systems and include cases in which a First Responder was activated via the DAE RespondER system. The study population reflects a real-world, unselected cohort of OHCA patients treated within an integrated regional emergency care system.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Usl di Bologna: lead

Study Sites (1)

Carlo Alberto Pizzardi Major Hospital

Bologna, Emilia-Romagna, Italy

Location

Related Publications (6)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 40123987 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Lorenzo Gamberini, Medical Doctor

CONTACT

+390516478215; lorenzo.gamberini@ausl.bologna.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Anesthesia and Intensive Care, MD

Study Record Dates

• First Submitted: May 10, 2026
• First Posted: May 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months after publication of the primary results and ending 5 years after publication.
• Access Criteria: 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.

Locations

IT (1)