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临床试验/NCT07589504
NCT07589504尚未招募不适用

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

Azienda Usl di Bologna1 个研究点 分布在 1 个国家目标入组 5,200 人开始时间: 2026年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
5,200
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

LORENZO GAMBERINI

Consultant in Anesthesia and Intensive Care, MD

Azienda Usl di Bologna

研究点 (1)

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