Validation of Early Warning Score & Lactate in Prehospital Screening

NCT02189096 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 705

Last updated 2015-12-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Abbott Point of Care

    collaborator INDUSTRY
  • University of the West of Scotland

    lead OTHER

Principal Investigators

  • Kevin Rooney · University of the West of Scotland

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-07-31
Completion
2015-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02189096 on ClinicalTrials.gov