Condition category
Circulatory System
Date applied
11/05/2020
Date assigned
21/05/2020
Last edited
16/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Out-of-hospital cardiac arrest (OHCA) (heart attack) 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.
The current COVID-19 pandemic has caused a series of changes in patient care that have a very important influence in the case of OHCA. The possibility of contagion has forced two major changes: emergency teams must take precautions and there are more restrictions for recommending an initial citizen intervention. Delays and reduced witnessed resuscitation may affect survival after OHCA. Researchers do not know their real influence, whether they will be maintained even when the pandemic ends, or if they will affect future CPR recommendations.

Who can participate?
OHCA patients treated with resuscitation by the emergency services or who received post-resuscitation care after cardiopulmonary resuscitation (CPR) attempts by a first responder

What does the study involve?
The incidence of resuscitation attempts, general characteristics, and survival at discharge of patients are all measured from medical records during the COVID-19 pandemic and the same three months 1 year later.

What are the possible benefits and risks of participating?
The study will show the impact of the pandemic on the different links of the chain of survival and if these changes keep over time.

Where is the study run from?
Emergency services in 15 Spanish regions

When is the study starting and how long is it expected to run for?
January 2020 to December 2021

Who is funding the study?
Spanish Resuscitation Council

Who is the main contact?
Fernando Rosell Ortiz, MD, PhD
frosell@riojasalud.es
fernandorosell@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Fernando Rosell Ortiz

ORCID ID

https://orcid.org/0000-0003-0260-9955

Contact details

Duques de Nájera 6
7 B
Logroño
26002
Spain
+34 (0)697958689
frosell@riojasalud.es

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

OHSCAR 3

Study information

Scientific title

Survival of patients suffering an out-of-hospital cardiac arrest treated by emergency services in Spain

Acronym

OHSCAR

Study hypothesis

A pandemic situation changes the real practice for out-of-hospital cardiac arrest management.

Ethics approval

Approved 03/07/2020, Research Ethics Committee, Department of Health of the Government of Navarra (Pabellón de Docencia (Teaching Pavilion). Irunlarrea 3, Pamplona 31 008, Spain; +34 (0)848822495; no email address provided), ref: PI_2020/60
Approved 29/07/2020, Drug Research Ethics Committee of La Rioja (Edificio CIBIR. Piqueras 98, 3ª planta. 26006 Logroño. La Rioja, Spain; +34 (0)941 278855; secretaria.ceic@riojasalud.es), ref: CEImLAR P.I. 427

Study design

Observational retrospective multicentre study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Out-of-hospital cardiac arrest (OHCA)

Intervention

Continous registry of OHCA patients according to Utstein style guidelines to determine the incidence, general characteristics, and survival at discharge of patients attended by Spanish emergency services. The researchers use pre-hospital medical records provided by emergency services and in-hospital medical records, only in cases with successful resuscitation, to assess in-hospital evolution and status at discharge.

First phase: 01/02/2020 to 31/03/2020. Three months during the rise, stabilisation and decline of the COVID-19 pandemic in Spain.

Second phase: 01/02/2021 to 31/03/2021. The same three months 1 year later.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Survival at hospital discharge with good neurological status, expressed as percentage of patients with Cerebral Performance Category scale ≤ 2, during the COVID-19 pandemic and 1 year later

Secondary outcome measures

Measured using medical records during the COVID-19 pandemic and 1 year later:
1. Incidence of resuscitation attempts expressed as the number of resuscitations attempts per 105 inhabitants
2. Bystander reanimation expressed as percentage of cases with bystander reanimation excluding those cases witnessed by emergency teams
3. Airway management expressed as percentage of cases with airway isolation

Overall trial start date

23/01/2020

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Cases of OHCA in which an EMS performed resuscitation or post-resuscitation care after cardiopulmonary resuscitation (CPR) attempts by a first responder

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

In Spain there are 17 emergency public services (17 regions). At the moment there 13 of them are involved (more than 80% of Spanish total population). Based on previous data, the researchers estimate about 2000 – 2500 cases per three months period.

Total final enrolment

8629

Participant 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)

Recruitment start date

01/02/2020

Recruitment end date

31/03/2021

Locations

Countries of recruitment

Spain

Trial participating centre

Servicio de Urgencias y emergencias Médicas 061 de La Rioja
Hospital San Pedro C/ Piqueras 92
Logroño
26006
Spain

Trial participating centre

Servicio de Urgencia Médica de la Comunidad de Madrid, SUMMA 112
Antracita 2, bis
Madrid
28045
Spain

Trial participating centre

Subdirección de urgencias y atención a la urgencia vital de Navarra
Plaza de la Paz s/n
Pamplona
31002
Spain

Trial participating centre

Emergentziak Osakidetza
María Díaz de Haro 53
Bilbao
48010
Spain

Trial participating centre

061 Aragón
Avenida Navarra 78, 2ª planta
Zaragoza
50011
Spain

Trial participating centre

Gerencia de Emergencias Sanitarias de Castilla y León
Paseo Hospital Militar 24-2
Valladolid
47007
Spain

Trial participating centre

Emergencies Mediques. Departament de Salut.
Pablo Iglesias, 101-115
L'Hospitalet de Llobregat
08908
Spain

Trial participating centre

SAMUR - Protección Civil
Ronda de las Provincias, 7
Madrid
28011
Spain

Trial participating centre

Urxencias sanitarias 061
Rúa da Cultura, s / n
A Estrada (Pontevedra)
36680
Spain

Trial participating centre

Gerencia de urgencias y emergencias 061 del Servicio Murciano de Salud
Calle escultor José Sánchez Lozano 7 segunda planta
Murcia
30005
Spain

Trial participating centre

Servicio de Emergencias 061 Cantabria
Rosalía de Castro s/n
Santander
39011
Spain

Trial participating centre

Servicio de Atención Médica Urgent 061 de las Islas Baleares
Carrer Illes Balears, 1B
Palma de Mallorca
07014
Spain

Trial participating centre

Emergencias Sanitarias de Extremadura 112
Subdireccion de Atención Primaria. AVD de la Américas nº 2. Mérida
Badajoz
06800
Spain

Trial participating centre

Servicio de Emergencias Sanitarias, Comunidad Valenciana
Avenida Campanar 21 - 5 A Planta Escola Enf la Fe (Servici D'Emergencies Sanitaries - Valencia)
Valencia
46009
Spain

Sponsor information

Organisation

Fundación Pública Urxencias Sanitarias de Galicia-061

Sponsor details

Rúa da Cultura
s/n
A Estrada (Pontevedra)
36680
Spain
+34 (0)881 546 644
061@sergas.es

Sponsor type

Other

Website

https://061.sergas.gal/Paxinas/web.aspx

Organisation

SEM - Sistema d'Emergències Mèdiques

Sponsor details

C. Pablo Iglesias
101-115
Hospitalet de Llobregat
08908
Spain
+34 (0)9326444 00
sem@gencat.cat

Sponsor type

Other

Website

http://sem.gencat.cat/ca/contacte/

Organisation

Andalusian School of Public Health

Sponsor details

Cuesta del Observatorio 4
Campus Universitario de Cartuja
Granada
18080
Spain
+34 (0)958027400
comunicacion.easp@juntadeandalucia.es

Sponsor type

University/education

Website

https://www.easp.es/

Funders

Funder type

Other

Funder name

Spanish Resuscitation Council

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The first publication: Incidence, characteristics and survival of OHCA during a pandemic in Spain: summer 2020 (results of three months of 2020).

Two later publications at the end of 2021:
1. Incidence, characteristics, and survival of OHCA 1 year after the COVID-19 pandemic in Spain
2. Changes in first links of the chain of survival due to a COVID-19 pandemic. Results of the Spanish registry of OHCA

IPD sharing statement
The data provided by the participating emergency services are anonymous. In Spain, every health service has the duty to safeguards its medical records, as well as to control their quality. The variables of each case are transcribed into a standardized database, homogeneous for the study, and which follows the definitions of the Utstein 2014 style.
The project uses exclusively coded tables, exported by the EMS involved in Excel or SPSS for subsequent statistical analysis. It is not possible to identify and correlate the data in the database with specific patients. Each service requests the appropriate consents from the reference ethics committees. In general, Spanish legislation allows the use of anonymized data from patients' medical records to evaluate health outcomes.

Intention to publish date

01/07/2020

Participant level data

Other

Basic results (scientific)

Publication list

2020 results in https://pubmed.ncbi.nlm.nih.gov/33049385/ (added 16/10/2020)

Publication citations

Additional files

Editorial Notes

16/10/2020: The following changes were made to the trial record: 1. Publication reference added. 2. The total final enrolment was added. 03/08/2020: Ethics approval details added. 23/07/2020: Ethics approval details added. 28/05/2020: Trial participating centres added: Emergencias Sanitarias de Extremadura 112 and Servicio de Emergencias Sanitarias, Comunidad Valenciana. 21/05/2020: Trial's existence confirmed by the Spanish Resuscitation Council.