Validation of Early Warning Score & Lactate in Prehospital Screening

NCT02189096 | Completed

• 1 other identifier: VELPS
• Study Type: observational
• Target: 705
• Locations: 0 countries
• Sites: N/A

Brief 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

Sepsis

Keywords

Sepsis; National Early Warning Score; Lactate

Outcome Measures

Primary Outcomes (1)

• Intensive Care Unit admission within 48 hours of attendance

  Intensive Care Unit admission within 48 hours of attendance 24 hour mortality (all cause) 30 day mortality (all cause, in hospital)

  one year

Secondary Outcomes (4)

• Time from 999 call to ED arrival

  one year

• Time from Scottish Ambulance Service arrival to ED arrival

  one year

• On-scene time for Scottish Ambulance Service

  one year

• Cost analysis

  one year

Study Arms (3)

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

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

Interventions

NEWS and Sepsis Screening OTHER

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.

NEWS and Sepsis Screening

Point of care lactate measurement OTHER

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.

Point of care lactate measurement

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from five Scottish healthboard areas.

You may qualify if:

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

You may not qualify if:

• Patients in cardiac arrest
• Children less than 16 years of age
• Patients with incomplete data collection

Sponsors & Collaborators

• University of the West of Scotland: lead
• Abbott Point of Care: collaborator

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Rooney

  University of the West of Scotland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 14, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 7, 2015

Record last verified: 2015-12