Condition category
Not Applicable
Date applied
21/10/2018
Date assigned
26/10/2018
Last edited
09/12/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
The early detection of time-dependent diseases is a priority of health systems. The National Early Warning Score 2 (NEWS2) is a tool capable of identifying subtle signs of deterioration, hours before a serious adverse event. By using this scale, it is possible to detect sensitive patients at high risk.
Another tool that can help reduce diagnostic uncertainty are portable analytical devices, which reduce the time window from the beginning of the symptoms to a diagnosis. One such tool measures lactic acid levels.
Scales and tools cannot substitute a correct objective and structured clinical evaluation, but we believe that the proposed new scale, called prehospital NEWS2-Lactate (preNEWS2-L), composed of the NEWS2 scale and lactic acid levels, which can help to guide professionals in their practice.

Who can participate?
Patients who are assisted by ALSU in the different cities involved in the study and transferred to the Emergency Department of their referral hospital.

What does the study involve?
Once assistance is complete, a researcher in each ALSU is in charge of collecting from the emergency medical record demographic variables (sex and age), reason for calling (medical pathology, traffic accident, labor or casual, social demand or other), times of arrival, assistance and transfer, and clinical variables necessary to be able to carry out the NEWS2. Aanalytical variables were also collected, including the level of blood glucose and lactic acid in venous blood.
Subsequently, a researcher in each hospital monitored the electronic history of the patient 30 days after emergency care to collect their final diagnosis, complementary tests (ultrasound, endoscopy and/or scan), surgical interventions, destination in the hospital (discharge or admission), need for Intensive Care Unit (ICU) and days of admission.

What are the possible benefits and risks of participating?
Through the implementation of this application 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?
1. Gerencia de Emergencias Sanitarias de Castilla y León (Spain)
2. Hospital Clínico Universitario de Valladolid (Spain)
3. Hospital Universitario Rio Hortega (Spain)

When is the study starting and how long is it expected to run for?
January 2018 to May 2020

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

Scientific

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GRS-1678/A/18

Study information

Scientific title

Longitudinal observational study to evaluate the use of the prehospital scale National Early Warning Score Lactate (preNEWS-L)

Acronym

preNEWS-L

Study hypothesis

The working hypothesis consists of evaluating the use of the pre-NEWS-L scale as a diagnostic tool in the prehospital setting. We want to verify if this scale is able to predict with a high degree of efficiency the early mortality at 2 and 7 days

Ethics approval

The study was approved on 9 March 2018,
Clinical Research Ethics Committee at the Río Hortega University Hospital and the University Clinic Valladolid (Spain), 09/03/2018, registration codes #PI 18-010 & #PI 18-895 (respectively)

Study design

Observational prospective longitudinal study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Other

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 assessed at first attention at the scene of the incident:
1. Respiratory frequency, assessed using clinical observation
2. Oxygen saturation, assessed using a Physio LifePAK® 15 monitor
3. Heart rate, assessed using a Physio LifePAK® 15 monitor
4. Blood pressure, assessed using a Physio LifePAK® 15 monitor
5. Tympanic temperature assessed using a Braun model ThermoScan® PRO 6000
6. Patient consciousness, assessed using the Glasgow Coma Scale
7. Use of oxygen (or not), assessed using clinical observation
8. Lactic acid levels, assessed using an Accutrend® Plus meter
9. Blood glucose, assessed using an Accu-Chek® Aviva

Secondary outcome measures

The following are assessed using a review of electronic medical records within 30 days of the index event:
1. Main diagnosis
2. Mortality
3. Days of admission
4. Need for ICU
5. Complementary tests requested

Overall trial start date

30/10/2019

Overall trial end date

02/05/2020

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

937

Total final enrolment

3081

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

01/04/2018

Recruitment end date

30/10/2019

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

Trial participating centre

Hospital Clínico Universitario de Valladolid
Avda. Ramón y Cajal nº3
Valladolid
47003
Spain

Trial participating centre

Hospital Universitario Rio Hortega
Calle Dulzaina, 2
Valladolid
47012
Spain

Sponsor information

Organisation

Gerencia de Emergencias Sanitarias de Castilla y León

Sponsor details

Calle Antiguo Hospital Militar 2ª planta
Valladolid
47006
Spain

Sponsor type

Hospital/treatment centre

Website

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

Funders

Funder type

Not defined

Funder name

Gerencia Regional de Salud

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

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

01/06/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

1. 2019 results in ncbi.nlm.nih.gov/pubmed/31648657 (added 09/12/2019)
2. 2019 results in ncbi.nlm.nih.gov/pubmed/30998648 (added 09/12/2019)
3. 2019 results in ncbi.nlm.nih.gov/pubmed/30627928 (added 09/12/2019)
4. 2019 results in ncbi.nlm.nih.gov/pubmed/30471934 (added 09/12/2019)

Publication citations

Additional files

Editorial Notes

09/12/2019: The following changes were made to the trial record: 1. The overall end date was changed from 12/01/2018 to 30/10/2019. 2. The recruitment end date was changed from 30/12/2019 to 30/10/2019. 3. The total final enrolment was added. 4. Publication references added.