Condition category
Not Applicable
Date applied
31/10/2019
Date assigned
04/11/2019
Last edited
04/11/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Time-dependent diseases represent one of the most frequent causes of care by the Emergency Medical Services (EMS), one of the most frequent reasons for hospitalization and one of the main potential causes of early mortality. Health systems are making efforts to implement protocols for the management of this specific type of pathologies (infarction code, ICTUS, sepsis, etc). Being aware of the pathophysiological situation of the patient is essential to manage the situation, where early diagnosis is essential. The EMS perform standard advanced life support manoeuvres, with a wide technical capacity, but with very limited diagnostic means. For this reason, the general objective is to evaluate the prognostic capacity of the National Early Warning Score 2 scale, of prehospital analysis and of the joint level capnometry data (HITS score), to predict early mortality (before 48 hours) from the index event.

Who can participate?
Patients attended by Advanced Life Support (ALS) in the province of Valladolid

What does the study involve?
Patients undergo a structured and objective evaluation according to protocol and proceed to its stabilization. Respiratory rate, saturation, heart rate, blood pressure, temperate, coma scale score, and blood levels of lactic acid and glycemia values are measured. Once the patient is left in the Emergency Department they follow the normal course of treatment. 30 days after the index event (ALSU's attention at the scene) an analysis of the electronic clinical history of the participant is made to collect data on their hospital care and mortality data. At this moment, the observation will end. No interventions are performed on patients depending on the HITScore scale, but if the analytical or physiological data indicate urgent pathology, it will be acted on according to the EMS operating procedures. All participants receive the most appropriate treatment for their situation, regardless of the results of the study.

What are the possible benefits and risks of participating?
Through the use of this early warning scale, the clinical safety of patients is increased since the health system can perform a comprehensive follow-up of their situation. The scale also uses language easily understood by patients and professionals, which helps to facilitate the transmission of information. A delay in the timely identification of the critical pathology of the patient has a direct impact on the health system, with an increase in diagnostic procedures and surgical techniques, hospitalizations, stays in intensive care units or unexpected deaths. With the early identification of patients at high risk, it is intended to reduce morbidity and mortality. There are no known risks to participants taking part in this study.

Where is the study run from?
Health Emergency Management of Castilla y León (Spain), University Clinical Hospital of Valladolid (Spain), Rio Hortega University Hospital (Spain).

When is the study starting and how long is it expected to run for?
November 2019 to December 2021

Who is funding the study?
Regional Health Management of Castilla y León (SACYL) (Spain)

Who is the main contact?
Francisco Martín-Rodríguez
fmartin@saludcastillayleon.es

Trial website

Contact information

Type

Public

Primary contact

Dr Francisco Martín-Rodríguez

ORCID ID

http://orcid.org/0000-0002-1773-2860

Contact details

Medicine Faculty. Valladolid University
Av. Ramón y Cajal
7
Valladolid
47005
Spain
+34 (0)686452313
fmartin@phet.es

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

GRS/1903/A/19

Study information

Scientific title

Predictive value of biological, physiological and analytical biomarkers in the prehospital scope: observational, prospective, analytical, non-intervention and multicenter study

Acronym

HITScore

Study hypothesis

Evaluate the prognostic capacity of different early warning scales (EWS, NEWS2, qSOFA, etc.), analytical biomarkers, and ETCO2 data, separately and at the joint level (HITS score) obtained at the prehospital level, to predict early mortality (before 48 hours) from the index event.

Ethics approval

1. Approved 07/10/2019, Comité de Ética de la Investigación con Medicamentos Área de Salud Valladolid Este (Hospital Clínico Valladolid, Facultad de Medicina, Farmacología, C/ Ramón y Cajal, 7 47005 Valladolid, España; Tel: 983 42 30 77; Email: alvarez@med.uva.es, jalvarezgo@saludcastillayleon.es), ref: PI-GR-19-1258
2. Approved 05/03/2019, CEIC Área de Salud de Valladolid Oeste (Hospital Universitario Río Hortega, 47012 Valladolid (Valladolid); Tel: 983 420 400; Email: rconvi@saludcastillayleon.es), ref: PI041-19

Study design

Observational prospective cross-sectional cohort analytical non-intervention and multicenter study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Community

Trial type

Prevention

Patient information sheet

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

Condition

Early mortality in all types of patients without evident signs of severity

Intervention

Patients and/or participants undergo a structured and objective evaluation according to protocol and proceed to its stabilization. The physiological variables are collected (respiratory rate, saturation, heart rate, blood pressure, temperate, coma scale score), and blood determination (capillary or venous if it is channeled via venous) of lactic acid and glycemia values is completed.

Once the patient is left in the Emergency Department they will follow the normal course of treatment. 30 days after the index event (ALSU's attention at the scene) an analysis of the electronic clinical history of the participant is made to collect the data of their hospital care and mortality data. At this moment, the observation will end.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

The following are evaluated at first attention at the scene of the incident:
1. Respiratory frequency, assessed using clinical observation at baseline
2. Oxygen saturation, assessed using a Physio LifePAK® 15 monitor at baseline
3. Non invasive ETCO2, assessed using a Physio LifePAK® 15 monitor at baseline
4. Heart rate, assessed using a Physio LifePAK® 15 monitor at baseline
5. Blood pressure, assessed using a Physio LifePAK® 15 monitor at baseline
6. Tympanic temperature assessed using a Braun model ThermoScan® PRO 6000 at baseline
7. Patient consciousness, assessed using the Glasgow Coma Scale at baseline
8. Use of oxygen (or not), evaluated using clinical observation at baseline
9. Analytical biomarkers: pH, pCO2, pO2, cHCO3-, BE (ecf), cSO2, Na +, K +, Ca ++, Cl-, TCO2, Agap, AGapK, Hct, Hb, BE (b), Glu, Lac, BUN, Urea and Crea, assessed using EPOC Siemens Healthcare at baseline
10. Electrocardiogram assessed using a Physio LifePAK® 15 monitor at baseline
11. Initial and route FiO2 assessed using a Physio LifePAK® 15 monitor at baseline
12. Prehospital diagnosis according to the Medical Priority Dispatch System incident code at baseline

Secondary outcome measures

1. Early mortality at 48 hours
2. Presence of serious adverse events in prehospital scope at baseline
3. Presence of serious adverse events in hospital at 48 hours
4. Need for Intensive Care Unit at 30 days
5. Mortality from any cause at 30 days

Overall trial start date

15/11/2019

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Treated by an ALSU
2. Aged over 18 years
3. Provide informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

900

Participant exclusion criteria

1. Aged under 18 years
2. Cardiorespiratory arrest or exitus prior to arrival at the hospital
3. Pregnant
4. Psychiatric pathology
5. Diagnosis of end-stage disease (in treatment at a palliative care unit)
6. ALSU takes longer than 45 minutes to arrive
7. Evacuated by transport other than ambulance
8. Do not require transfer to the hospital

Recruitment start date

01/12/2019

Recruitment end date

30/10/2021

Locations

Countries of recruitment

Spain

Trial participating centre

Gerencia de Emergencias Sanitarias de Castilla y León
C/ Antiguo Hospital Militar, s/n
Valladolid
47006
Spain

Sponsor information

Organisation

Gerencia de Emergencias Sanitarias de Castilla y León

Sponsor details

Calle Antiguo Hospital Militar 2ª planta
Valladolid
47006
Spain
+34 (0)983141061
fmartin@saludcastillayleon.es

Sponsor type

Government

Website

https://www.saludcastillayleon.es/ciudadanos/es/urgencias-emergencias/emergencias-sanitarias-castilla-leon

Funders

Funder type

Government

Funder name

Gerencia Regional de Salud de Castilla y León

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Universidad de Valladolid

Alternative name(s)

University of Valladolid, UVA

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Spain

Results and Publications

Publication and dissemination plan

There is a study protocol and analysis plan that can be sent upon reasonable request.

The research team will promote the dissemination of the results obtained in various scientific publications:
1. American Journal of Medicine
2. Critical Care Medicine
3. Emergencies
4. Intensive Care Medicine
5. Prehospital & Emergency Care
6. Resuscitation
If external funding is obtained, communications could be sent to the main international emergency and emergencies forums

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from (F. Martín-Rodríguez, fmartin@saludcastillayleon.es). Statistical data will be available from the end of the data collection phase for 4 years. The data may be shared with researchers carrying out similar studies, provided that the exchange of information is mutual, by sending the anonymized data of patients. Patients will have signed informed consent for data sharing.

Intention to publish date

30/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

01/11/2019: Trial's existence confirmed by ethics committee.