Validation of Early Warning Score & Lactate in Prehospital Screening (VELPS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by University of the West of Scotland
Sponsor:
Collaborator:
Abbott Point-of-Care
Information provided by (Responsible Party):
Kevin Rooney, University of the West of Scotland
ClinicalTrials.gov Identifier:
NCT02189096
First received: July 10, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

Sepsis claims over 37,000 lives in the United Kingdom each year- more than lung cancer, and more than breast cancer, bowel cancer and HIV/AIDS combined. Less than two-thirds of patients who develop sepsis will survive. Sepsis can affect a person of any age, social background, and can strike irrespective of underlying medical conditions.

An important element in improving the care of patient with sepsis is early identification and early intervention, both of which have been shown to improve outcomes. Physiological deterioration often precedes clinical deterioration as patients develop critical illness. Recognition of this has led to the development of Early Warning Score (EWS) systems which allow earlier identification of physiological deterioration. By assigning numerical values to various physiological parameters, a composite score can be assigned to a patient, allowing early identification of patients who are at risk of critical illness.

EWS were initially developed to assist in the management of patients in the general ward setting. A recent study has shown that an increased EWS on arrival at the Emergency Department (ED) is associated with higher odds of adverse outcome amongst patients with sepsis. Consequently, the use of EWS could facilitate patient pathways to ensure triage to a high acuity area of the ED and senior clinician involvement at an early stage. The use of a standard single National EWS (NEWS) across the National Health Service in the United Kingdom has been recommended to improve patient care.

NEWS also lends itself to extension to pre-hospital care and ambulance services. Most ambulance services routinely collect the physiological data required to calculate a NEWS score and indeed some ambulance services have incorporated this into electronic patient record forms (ePRF). An agreed NEWS score of greater than a specific level could be used as a trigger for ambulance service pre-alert of a receiving ED.

Point of care measurement of lactate has also been shown to be feasible in the ED. Serum lactate is recognised as an independent predictor of mortality in sepsis and there may be potential for combining NEWS systems and point of care to further improve diagnostic accuracy for patients at risk of adverse outcomes.

In this study, we aim to apply the use of early warning scores and point of care testing to a cohort of all ambulance patients to assess the feasibility and utility of this approach.


Condition Intervention
Sepsis
Other: NEWS and Sepsis Screening
Other: Point of care lactate measurement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Early Warning Score & Lactate in Prehospital Screening

Resource links provided by NLM:


Further study details as provided by University of the West of Scotland:

Primary Outcome Measures:
  • Intensive Care Unit admission within 48 hours of attendance [ Time Frame: one year ] [ Designated as safety issue: No ]
    Intensive Care Unit admission within 48 hours of attendance 24 hour mortality (all cause) 30 day mortality (all cause, in hospital)


Secondary Outcome Measures:
  • Time from 999 call to ED arrival [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Time from Scottish Ambulance Service arrival to ED arrival [ Time Frame: one year ] [ Designated as safety issue: No ]
  • On-scene time for Scottish Ambulance Service [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Cost analysis [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: July 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No change from current practice

Phase 1 (4 months)

No change from current practice. Each Paramedic crew routinely documents patient observations in an electronic Patient Report Form (ePRF) on every patient encounter. These physiological parameters will be electronically captured. The data will be used to calculate NEWS and screen for Sepsis (2 or more modified SIRS criteria [signs of systemic inflammation] and suspicion of infection) by the study investigators. An estimate will be made of the time of completion of the ePRF in relation to patient transport.

NEWS and Sepsis Screening

Phase 2 (4 months)

The ten crews will undertake implementation of NEWS and Sepsis Screening. Each Paramedic crew will continue to routinely document patient observations in an electronic Patient Report Form (ePRF) on every patient encounter. These physiological parameters will be used to calculate NEWS and screen for Sepsis (2 or more modified SIRS criteria and suspicion of infection). The NEWS will be available to the paramedic crew.

If NEWS is greater than or equal to 4 or the patient screens positive for Sepsis, the patients transfer will be as per normal protocol but receiving ED staff will receive the information about NEWS score and Sepsis screening as part of a structured handover.

Other: NEWS and Sepsis Screening
Each Paramedic crew will continue to routinely document patient observations in an electronic Patient Report Form (ePRF) on every patient encounter. These physiological parameters will be used to calculate NEWS and screen for Sepsis (2 or more modified SIRS criteria and suspicion of infection). The NEWS will be available to the paramedic crew.
Point of care lactate measurement

Phase 3 ( 4 months)

The ten crews will undertake Point of Care Lactate measurement when NEWS ≥ 4 or when the patient screens positive for Sepsis. Each Paramedic crew will continue to routinely document patient observations in an electronic Patient Report Form (ePRF) on every patient encounter. These physiological parameters will be used to calculate NEWS and screen for Sepsis (2 or more modified SIRS criteria and suspicion of infection).

If NEWS is greater than or equal to 4 or the patient screens positive for Sepsis, then a Lactate will be measured on the CG4+ i-STAT cartridge. The lactate level, along with the NEWS score and sepsis screening, will be given to the receiving ED staff as part of a structured handover.

Other: Point of care lactate measurement
Each Paramedic crew will continue to routinely document patient observations in an electronic Patient Report Form (ePRF) on every patient encounter. These physiological parameters will be used to calculate NEWS and screen for Sepsis (2 or more modified SIRS criteria and suspicion of infection). If NEWS is greater than or equal to 4 or the patient screens positive for Sepsis, then a Lactate will be measured on the CG4+ i-STAT cartridge.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients from five Scottish healthboard areas.

Criteria

Inclusion Criteria:

  • All patients attended to by the assigned paramedic teams over a 12 month period

Exclusion Criteria:

  • Patients in cardiac arrest
  • Children less than 16 years of age
  • Patients with incomplete data collection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02189096

Contacts
Contact: Kevin Rooney +44 1698 283100 ext 8645 kevin.rooney@uws.ac.uk

Sponsors and Collaborators
University of the West of Scotland
Abbott Point-of-Care
Investigators
Principal Investigator: Kevin Rooney University of the West of Scotland
  More Information

No publications provided

Responsible Party: Kevin Rooney, Professor, University of the West of Scotland
ClinicalTrials.gov Identifier: NCT02189096     History of Changes
Other Study ID Numbers: VELPS
Study First Received: July 10, 2014
Last Updated: July 10, 2014
Health Authority: United Kingdom: Approval has been given by the National Caldicott Guardian (UK), Research Ethics Approval is not required.

Keywords provided by University of the West of Scotland:
Sepsis
National Early Warning Score
Lactate

ClinicalTrials.gov processed this record on September 16, 2014