Randomized Controlled Pilot Study of Methods for Identifying Patients At High Risk of Worsening in the Adult Emergency Department

Summary

This study will be conducted in the Regional Emergency Room (ER) of the Dijon-Bourgogne University Hospital in Dijon, France. It is an interventional study that will have an impact on medical contact time.

Patients will be identified among adult patients presenting to the ER of the Dijon University Hospital. Each patient will be followed-up for 30 days from the time of arrival at the ER (if the inclusion criteria for the study are met).

A total of 337 patients will participate in this study and will be randomly allocated to 3 groups:

* Group 1 "controls - FRENCH grid only": patients will receive the same care and management as any other patient admitted for the same condition. Management is based on the use of the FRENCH grid only.
* Group 2 "FRENCH grid + QuickSOFA": In addition to the standard use of the FRENCH grid, a quick score called QuickSOFA is added. It consists in performing an evaluation based on 3 clinical criteria (blood pressure, respiratory rate and consciousness) to quickly establish a severity score.
* Group 3 "FRENCH grid + QuickSOFA + Capillary lactate": In addition to the use of the FRENCH grid and the QuickSOFA score, capillary lactate concentrations will be measured. This involves taking a drop of blood from the fingertip (less than 1ml). For diabetic patients, there will be no second sampling act, everything will be done from the same sample. All samples will be discarded after the result is displayed on the reader.

This study includes 2 visits:

\- D0 (adult ER visit): The patient's background, clinical and biological data will be collected. The patient will then be randomized into one of three groups. Depending on the group assigned, the triage nurse may perform QuickSOFA and lactate assessments.

\- Follow-up at D30: collection of follow-up information up to 30 days after inclusion in the emergency department: replacement therapy (mechanical ventilation, extracorporeal membrane oxygenation,…), dates of discharge from critical care and hospital, vital status and in case of death the date of its occurrence.

Conditions

• Non-traumatic Medical Emergency

Interventions

OTHER

FRENCH grid (classification for emergency nurses in French hospitals)

Triage tool validated by the French Society of Emergency Medicine (SFMU) which is used to prioritize patients according to standardized criteria and to orient them within the emergency department.

OTHER

QuickSOFA

Rapid score that consists of an evaluation based on 3 clinical criteria (blood pressure, respiratory rate and consciousness) to quickly establish a severity score.

OTHER

Capillary lactate assessment

Collect a drop of blood from the fingertip (less than 1 ml)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-08

Primary Completion

2024-12-27

Completion

2024-12-27

Countries

• France

Study Locations