Survival of patients suffering an out-of-hospital cardiac arrest treated by emergency services in Spain during the COVID-19 pandemic and 1 year later
| ISRCTN | ISRCTN10437835 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10437835 |
| Secondary identifying numbers | OHSCAR 3 |
- Submission date
- 11/05/2020
- Registration date
- 21/05/2020
- Last edited
- 29/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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 3 months 2 years later, in 2022.
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 July 2023
Who is funding the study?
Spanish Resuscitation Council
Who is the main contact?
Fernando Rosell Ortiz, MD, PhD
frosell@riojasalud.es
fernandorosell@gmail.com
Contact information
Scientific
Duques de Nájera 6, 7 B
Logroño
26002
Spain
 ORCID ID |
0000-0003-0260-9955 |
|---|---|
| Phone | +34 (0)697958689 |
| frosell@riojasalud.es |
Study information
| Study design | Observational retrospective multicentre study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Survival of patients suffering an out-of-hospital cardiac arrest treated by emergency services in Spain |
| Study acronym | OHSCAR |
| Study objectives | A pandemic situation changes the real practice for out-of-hospital cardiac arrest management. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 3 months 1 year later. Updated 30/12/2021: Second phase: Inclusion period, 1 year from 01/01/2022 to 31/12/2022. |
| Intervention type | Other |
| 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 study start date | 23/01/2020 |
| Completion date | 31/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | 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 |
| 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 | 01/02/2020 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- Spain
Study participating centres
C/ Piqueras 92
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
Murcia
30005
Spain
Santander
39011
Spain
Palma de Mallorca
07014
Spain
AVD de la Américas nº 2.
Mérida
Badajoz
06800
Spain
21 - 5 A Planta Escola Enf la Fe
(Servici D'Emergencies Sanitaries - Valencia)
Valencia
46009
Spain
Sponsor information
Other
Rúa da Cultura, s/n
A Estrada (Pontevedra)
36680
Spain
| Phone | +34 (0)881 546 644 |
|---|---|
| 061@sergas.es | |
| Website | https://061.sergas.gal/Paxinas/web.aspx |
Other
C. Pablo Iglesias, 101-115
Hospitalet de Llobregat
08908
Spain
| Phone | +34 (0)9326444 00 |
|---|---|
| sem@gencat.cat | |
| Website | http://sem.gencat.cat/ca/contacte/ |
University/education
Cuesta del Observatorio 4
Campus Universitario de Cartuja
Granada
18080
Spain
| Phone | +34 (0)958027400 |
|---|---|
| comunicacion.easp@juntadeandalucia.es | |
| Website | https://www.easp.es/ |
"ROR" |
https://ror.org/05wrpbp17 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/2020 | 16/10/2020 | Yes | No | |
| Results article | 02/01/2024 | 29/01/2024 | Yes | No |
Editorial Notes
29/01/2024: Publication reference added.
30/12/2021: The plain English summary and interventions were updated to reflect the new trial dates.
14/12/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2022 to 31/12/2022.
2. The overall trial end date was changed from 31/10/2022 to 31/07/2023.
3. The intention to publish date was changed from 31/12/2022 to 31/12/2023.
12/04/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2021 to 30/04/2022.
2. The overall trial end date was changed from 31/12/2021 to 31/10/2022.
3. The intention to publish date was changed from 01/07/2020 to 31/12/2022.
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.
