Field Paramedic Application of Sepsis Triage

NCT03870789 | Unknown

• 1 other identifier: 3075-C
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Given the implementation of the Hamilton Early Warning Score (HEWS) and the use of capnography by paramedics, this study will involve a large multi-site retrospective evaluation (before vs after implementation) of the HEWS score and comparison of the HEWS to systemic inflammatory response syndrome (SIRS), quick Sepsis Related Organ failure Assessment (qSOFA) and Modified Early Warning Score (MEWS) when applied retrospectively for the identification of sepsis in the prehospital setting.

Conditions

Sepsis

Keywords

sepsis, septic shock, early warning scores, infecion

Outcome Measures

Primary Outcomes (1)

• Accuracy of HEWS

  To determine the accuracy of the HEWS score, compared to qSOFA, and SIRS for early sepsis recognition when used in the prehospital setting by paramedics for the identification of patients with sepsis or suspected sepsis.

  1 year

Secondary Outcomes (2)

• Evaluate the addtion of end-tidal carbon dioxide (ETCO2) values

  1 year

• Evaluate sepsis alert program

  2 years

Study Arms (2)

Retrospective

The Investigators will examine data from 1-year prior to paramedic implementation of the Hamilton Early Warning Score tool.

Prospective

The Investigators will examine data from 1-year after paramedic implementation of the Hamilton Early Warning Score tool.

Eligibility Criteria

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

Study Population

Adults with suspected infection.

You may qualify if:

• Any patient to which paramedics apply the Hamilton Early Warning Score or patients who arrive to the Emergency Department (ED) by ambulance without a pre-alert and meet the definition of sepsis in the ED will also be included, and patient is ≥ 18 years

You may not qualify if:

• Patient is an inter-facility transfer, or patients with absent vital signs are absent, or death before blood can be drawn in the Emergency Department, or the patient fits the criteria for another prehospital alert (ST-elevation myocardial infarction, cerebrovascular vascular accident, or trauma)

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Hamilton Academic Health Sciences Organization: collaborator

Study Sites (1)

Centre for Paramedic Education and Research, Hamilton Health Sciences

Hamilton, Ontario, L8E 5E3, Canada

RECRUITING

Related Publications (3)

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 BACKGROUND

• Canadian Institute for Health Information. In Focus: A National Look at Sepsis.; 2009. https://secure.cihi.ca/free_products/HSMR_Sepsis2009_e.pdf.

  BACKGROUND

• Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.

  PMID: 11445675 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Officials

• Michelle Wellsford, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Clayton, CRA, RA

CONTACT

905-521-2100; clayton@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 12, 2019
• Study Start: December 11, 2016
• Primary Completion: May 1, 2019
• Study Completion: December 31, 2019
• Last Updated: March 12, 2019

Record last verified: 2019-03

Locations

CA (1)