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CompletedNCT05813431Quick-TRIUpdated Mar 27, 2025

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

An interventional study of FRENCH grid (classification for emergency nurses in French hospitals) and QuickSOFA in Non-traumatic Medical Emergency, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-27.

Sponsored by Centre Hospitalier Universitaire Dijon · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
337
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Non-traumatic Medical Emergency

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03

In context

Emergencies

1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.

This study's enrollment of 337 is above the median of 145 across 931 interventional studies indexed under Emergencies.

Browse Emergencies studies →

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients admitted to the Dijon-Bourgogne University Hospital emergency room between 12:00 am and 10:00 pm on weekdays for a medical emergency (non-traumatic)
  • Patients classified 3A 3B according to the FRENCH triage grid
  • Patient who gives verbal informed consent to take part in the study
  • Patient affiliated with national healthcare coverage (if not, the patient is redirected to the permanence of access to health care - PASS).

Exclusion criteria

Exclusion Criteria:

  • Patients admitted to the ER by the emergency services or having had a complete check-up in relation to the reason for transfer to the ER, therefore having had medical contact before hospital admission
  • Patients under palliative care for a defined condition
  • Person under legal protection (curatorship, guardianship)
  • Person under court order
  • Pregnant, parturient or breastfeeding woman
  • Adult who is unable to express consent

Secondary exclusion criteria:

  • Patients admitted for a stroke or suspected stroke referred either directly or after a delay to the specific stroke care pathway are excluded.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
337 participants (actual)

Study arms

  • Active comparator
    Control - FRENCH grid only

    Other: FRENCH grid (classification for emergency nurses in French hospitals)

  • Active comparator
    FRENCH grid + QuickSOFA

    Other: FRENCH grid (classification for emergency nurses in French hospitals) · Other: QuickSOFA

  • Active comparator
    FRENCH grid + QuickSOFA + Capillary Lactate

    Other: FRENCH grid (classification for emergency nurses in French hospitals) · Other: QuickSOFA · Other: Capillary lactate assessment

Interventions

  • OtherFRENCH 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.

  • OtherQuickSOFA

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

  • OtherCapillary lactate assessment

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

06

What researchers measure

Primary outcomes

  1. Waiting time in minutes between contact with the triage nurse and the first medical contact in the emergency room

    Time frame: At inclusion

07

Study locations

1 site
  • Chu Dijon Bourgogne
    Dijon, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05813431
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Apr 14, 2023
Start date
Sep 8, 2023
Primary completion
Dec 27, 2024
Completion
Dec 27, 2024
Last update
Mar 27, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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