Non-traumatic Medical EmergencyQuick-TRINCT05813431
Randomized Controlled Pilot Study of Methods for Identifying Patients At High Risk of Worsening in the Adult Emergency Department
A study testing FRENCH grid (classification for emergency nurses in French hospitals), QuickSOFA and Capillary lactate assessment in people with Non-traumatic Medical Emergency, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-traumatic Medical Emergency
- What is being tested?
- FRENCH grid (classification for emergency nurses in French hospitals), QuickSOFA and Capillary lactate assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2023to 27 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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
- Being tested
- FRENCH grid (classification for emergency nurses in French hospitals), QuickSOFA, Capillary lactate assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRENCH grid (classification for emergency nurses in French hospitals)Other
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.
QuickSOFAOther
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 assessmentOther
Collect a drop of blood from the fingertip (less than 1 ml)
| Study group | Role | What they receive |
|---|---|---|
| Control - FRENCH grid only | Active comparator | Not described Receives: Other: FRENCH grid (classification for emergency nurses in French hospitals) |
| FRENCH grid + QuickSOFA | Active comparator | Not described Receives: Other: FRENCH grid (classification for emergency nurses in French hospitals); Other: QuickSOFA |
| FRENCH grid + QuickSOFA + Capillary Lactate | Active comparator | Not described Receives: Other: FRENCH grid (classification for emergency nurses in French hospitals); Other: QuickSOFA; Other: Capillary lactate assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waiting time in minutes between contact with the triage nurse and the first medical contact in the emergency room
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start8 Sep 2023
- Primary completion27 Dec 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-traumatic Medical EmergencyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813431
- Sponsor's protocol ID
- GALOPIN AOIparaM 2021
- Acronym
- Quick-TRI
- Status last verified
- Mar 2025
- First submitted
- 3 Apr 2023
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Study of Methods for Identifying Patients At High Risk of Worsening in the Adult Emergency Department
- ClinicalTrials.gov ID
- NCT05813431
- Acronym / sponsor ID
- Quick-TRI / GALOPIN AOIparaM 2021
- Conditions
- Non-traumatic Medical Emergency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control - FRENCH grid only | Active comparator | Other: FRENCH grid (classification for emergency nurses in French hospitals) |
| FRENCH grid + QuickSOFA | Active comparator | Other: FRENCH grid (classification for emergency nurses in French hospitals), Other: QuickSOFA |
| FRENCH grid + QuickSOFA + Capillary Lactate | Active comparator | Other: FRENCH grid (classification for emergency nurses in French hospitals), Other: QuickSOFA, Other: Capillary lactate assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Control - FRENCH grid only, FRENCH grid + QuickSOFA, FRENCH grid + QuickSOFA + Capillary Lactate |
| QuickSOFARapid score that consists of an evaluation based on 3 clinical criteria (blood pressure, respiratory rate and consciousness) to quickly establish a severity score. | Other | FRENCH grid + QuickSOFA, FRENCH grid + QuickSOFA + Capillary Lactate |
| Capillary lactate assessmentCollect a drop of blood from the fingertip (less than 1 ml) | Other | FRENCH grid + QuickSOFA + Capillary Lactate |
Primary outcome
Waiting time in minutes between contact with the triage nurse and the first medical contact in the emergency room
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Non-traumatic Medical Emergency
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Non-invasive Intracranial Pressure Monitoring to Improve Emergency Care in Brazil's Public Health System
Traumatic Brain Injury (TBI) Patients, Stroke Hemorrhagic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRENCH grid (classification for emergency nurses in French hospitals), QuickSOFA and Capillary lactate assessment in people with Non-traumatic Medical Emergency, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waiting time in minutes between contact with the triage nurse and the first medical contact in the emergency room (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.