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
Authorizations have been requested from the corresponding committees responsible for each health administration on which the participating emergency services depend. Spanish legislation makes it possible for the approval of a regional committee to be sufficient to authorize the study. Given the current situation, the requested permissions can be delayed.
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.
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
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