Randomized Controlled Pilot Study of Methods for Identifying Patients At High Risk of Worsening in the Adult Emergency Department
NCT ID: NCT05813431
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
337 participants
INTERVENTIONAL
2023-09-08
2024-12-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Control - FRENCH grid only
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.
FRENCH grid + QuickSOFA
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.
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.
FRENCH grid + QuickSOFA + Capillary Lactate
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.
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.
Capillary lactate assessment
Collect a drop of blood from the fingertip (less than 1 ml)
Interventions
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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.
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.
Capillary lactate assessment
Collect a drop of blood from the fingertip (less than 1 ml)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
\- Patients admitted for a stroke or suspected stroke referred either directly or after a delay to the specific stroke care pathway are excluded.
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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Chu Dijon Bourgogne
Dijon, , France
Countries
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Other Identifiers
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GALOPIN AOIparaM 2021
Identifier Type: -
Identifier Source: org_study_id
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