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

10. maj 2026 opdateret af: LORENZO GAMBERINI, Azienda Usl di Bologna

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

5200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Italien
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italien

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Survival at 30 Days After Out-of-Hospital Cardiac Arrest
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Survival at 6 Months After Out-of-Hospital Cardiac Arrest
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Azienda Usl di Bologna

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

10. maj 2026

Først indsendt, der opfyldte QC-kriterier

10. maj 2026

Først opslået (Faktiske)

15. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 116-2026-OSS-AUSLBO

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Data will be available beginning 6 months after publication of the primary results and ending 5 years after publication.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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