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

2026年5月10日 更新者: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.

研究概览

地位

尚未招聘

研究类型

观察性的

注册 (估计的)

5200

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Emilia-Romagna
      • Bologna、Emilia-Romagna、意大利

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Survival at 30 Days After Out-of-Hospital Cardiac Arrest
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Survival at 6 Months After Out-of-Hospital Cardiac Arrest
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月1日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年5月10日

首先提交符合 QC 标准的

2026年5月10日

首次发布 (实际的)

2026年5月15日

研究记录更新

最后更新发布 (实际的)

2026年5月15日

上次提交的符合 QC 标准的更新

2026年5月10日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • 116-2026-OSS-AUSLBO

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

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 共享时间框架

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

IPD 共享访问标准

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 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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