Spanish registry of patients suffering an out-of-hospital cardiac arrest treated by emergency services
| ISRCTN | ISRCTN70329506 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70329506 |
- Submission date
- 19/02/2023
- Registration date
- 22/02/2023
- Last edited
- 21/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Out-of-hospital cardiac arrest (OHCA) is a major public health problem. Patient survival depends on a series of precise and coordinated actions that must be established from the moment of patient collapse. Society, the citizens themselves, are a fundamental part of the chain of survival.
All EMS are committed to improving care and outcomes in OHCA. Participation in a common registry, with homogeneous definitions, methods and quality controls, will allow to know and adapt best clinical practices, reduce variability and promote lines of research.
The Out-of-Hospital Spanish Cardiac arrest Registry (OHSCAR) started in 2013. Since its creation has collected data in defined periods. From 2023 it changes its recruitment periods and becomes a continuous OHCA registry. (Proyecto OHSCAR - CERCP)
Who can participate?
Spanish public EMSs caring for patients with cardiac arrest.
The Research group on Bioengineering and Resuscitation (BioRes). Its main research line is the application of Digital Signal Processing and Machine Learning to biomedical signals. BIORES - Escuela de Ingeniería de Bilbao - UPV/EHU
The EASP is a strategic and instrumental company of the SSPA and SNS for the innovation of health systems, the improvement of population’s health, and the promotion of scientific and technical collaboration and exchange, at national and international level Escuela Andaluza de Salud Pública (easp.es)
What does the study involve?
Incidence of resuscitation attempts, general patient and event characteristics, treatment received and survival to discharge of patients treated by Spanish EMS.
What are the possible benefits and risks of participating?
The registry will allow the implementation of a quality circle in each participating EMS and, as a whole, to know the clinical practice and health outcomes of OHCA care in Spain. It will facilitate comparison and benchmarking between EMSs and integration with different national and international research projects.
Where is the study run from?
Emergency Services in 13 Spanish regions and in two major capitals (Madrid y Zaragoza). Population served over 40 million inhabitants.
When is the study starting and how long is it expected to run for?
January 2023 to December 2043
Who is funding the study?
Spanish Resuscitation Council (Spain)
RiojaSalud Foundation (Spain)
Who is the main contact?
Dr. José I. Ruiz Azpiazu, jirazpiazu@riojasalud.es / jirazpiazu@gmail.com
Fernando Rosell Ortiz, MD, PhD, frosell@riojasalud.es / fernandorosell@gmail.com
Contact information
Scientific
Perez Galdos, 55 - 6
Logroño
26005
Spain
 ORCID ID |
0000-0002-1353-2597 |
|---|---|
| Phone | +34 639300522 |
| jirazpiazu@riojasalud.es |
Scientific
Duques de Najera 6
Logroño
26002
Spain
| ORCID ID |
0000-0003-0260-9955 |
|---|---|
| Phone | +34 697958689 |
| frosell@riojasalud.es |
Study information
| Study design | Observational retrospective multicentre study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Epidemiological study |
| Study setting(s) | Medical and other records |
| Study type | Other |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Survival of patients suffering an out-of-hospital cardiac arrest treated by emergency services in Spain. Out-of-Hospital Spanish Cardiac arrest Registry |
| Study acronym | OHSCAR |
| Study objectives | To know the epidemiology, treatment, survival and changes in the clinical practice for the out-of-hospital cardiac arrest management in Spain will improve the survival of these patients. |
| Ethics approval(s) | Approved 31/01/2023, Ethical Committee of La Rioja (Edificio CIBIR – 3 planta, C/ Piqueras 98, 26006, Logroño – La Rioja, Spain; +34 941 278 855. Ext. 84780; secretaria.ceic@riojasalud.es), ref: CEImLAR PI 647 |
| Health condition(s) or problem(s) studied | Survival in Out-of-hospital cardiac arrest (OHCA) |
| Intervention | Continuous registry of OHCA patients attended by Spanish emergency services EMS. The registry follows the Utstein template guidelines to report OHCA variables. The researchers are SEM professionals participating in the OHSCAR registry. They use the pre-hospital medical records and the in-hospital ones, in cases with successful resuscitation, to assess the treatment, evolution and status at discharge. |
| Intervention type | Other |
| Primary outcome measure | Survival at hospital discharge with good neurological status (Cerebral Performance Category scale ≤ 2) measured using patient records |
| Secondary outcome measures | The registry incorporates variables of the event (place, witnessed, time), the patient (sex, age), the treatment received (basic life support, advanced life support, times intervals), the outcome after resuscitation (dead, recovery of spontaneous pulse, transfer to hospital), hospital treatment (coronary intervention, active temperature control), neurological status at discharge (cerebral performance categories scale). Follow-up at one month. The sources of data are; the medical records of the emergency services, the call data and schedules from the dispatching centers and the follow-up from the patients' digital health records (hospital data and revisions after discharge) |
| Overall study start date | 01/01/2023 |
| Completion date | 31/12/2048 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | It is a project based on a continuous registry. There are 17 regions in Spain. Each of them has a public out-of-hospital emergency service. Two large cities, Madrid and Zaragoza, also have their own EMS. At the moment 15 of these EMS are involved (more than 80% of Spanish total population). Based on previous data, the researchers estimate about 10000 cases / year. |
| Key inclusion criteria | Cases of OHCA in which an EMS performed resuscitation or post-resuscitation care after cardiopulmonary resuscitation (CPR) attempts by a first responder |
| Key exclusion criteria | Cases in which the EMS suspended resuscitation on the grounds that it was not indicated due to futility criteria confirmed during resuscitation. An attempt at CPR was considered futile when new data during resuscitation showed that it was not indicated (terminal disease, prolonged arrest time prior to EMS arrival, “Do not resuscitate” orders) |
| Date of first enrolment | 01/01/2024 |
| Date of final enrolment | 31/12/2048 |
Locations
Countries of recruitment
- Spain
Study participating centres
Logroño
26006
Spain
Madrid
28045
Spain
Pamplona
31002
Spain
Bilbao
48010
Spain
Zaragoza
50011
Spain
Valladolid
47007
Spain
L´Hospitalet de Llobregat
08908
Spain
Madrid
28011
Spain
A Estrada (Pontevedra)
36680
Spain
Muercia
30005
Spain
Santander
39011
Spain
Palma de mallorca
07014
Spain
Merida
06800
Spain
21 - 5 A Planta Escola Enf la Fe
Valencia
46009
Spain
Sponsor information
Research council
Fuencarral, 18
Madrid
28004
Spain
| Phone | +34 626745227 |
|---|---|
| coordinacion@cercp.org | |
| Website | https://www.cercp.org/ |
Research organisation
Piqueras 98
Logroño
26006
Spain
| Phone | +34 941298000 |
|---|---|
| gestion_frs@riojasalud.es | |
| Website | https://www.fundacionriojasalud.org/ |
Research organisation
Juan Ignacio Luca de Tena, 12
Madrid
28027
Spain
| Phone | +34 639087778 |
|---|---|
| administracion@fundacionasisa.org | |
| Website | http://www.fundacionasisa.org/ |
Funders
Funder type
Research council
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Available on request |
| Publication and dissemination plan | A report every two years |
| IPD sharing plan | Spanish EMS are public services. Each of them depends on the corresponding health administration. The custody of the data corresponds to these administrations. The monitoring and traceability of the data is the responsibility of each EMS. The database centralized in the RiojaSalud Foundation includes anonymized alphanumeric data. Each EMS can access its own data and reports and its IP can access the general reports of the country. Access is allowed to the Spanish Ministry of Health and, upon request, with the consent of the EMS, raw case data could be accessed. Under these assumptions, access to anonymized data to verify an analysis, a report, or a publication would be feasible after the approval of the EMS that has provided the data for its realization. In this sense, the registry has a steering committee composed of the PI of each participating institution. |
Editorial Notes
21/03/2025: Asisa Foundation was added as a secondary sponsor.
22/09/2023: The recruitment start date was changed from 01/09/2023 to 01/01/2024.
22/02/2023: Trial's existence confirmed by Ethical Committee of La Rioja.
