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Randomized Controlled Pilot Study of Methods for Identifying Patients at High Risk of Worsening in the Adult Emergency Department (Quick-TRI)

Primary Purpose

Non-traumatic Medical Emergency

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
FRENCH grid (classification for emergency nurses in French hospitals)
QuickSOFA
Capillary lactate assessment
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Non-traumatic Medical Emergency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients admitted to the Dijon-Bourgogne University Hospital emergency room between 1:00 pm and 6:00 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: 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.

Sites / Locations

  • Chu Dijon BourgogneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control - FRENCH grid only

FRENCH grid + QuickSOFA

FRENCH grid + QuickSOFA + Capillary Lactate

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 3, 2023
Last Updated
September 11, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT05813431
Brief Title
Randomized Controlled Pilot Study of Methods for Identifying Patients at High Risk of Worsening in the Adult Emergency Department
Acronym
Quick-TRI
Official Title
Randomized Controlled Pilot Study of Methods for Identifying Patients at High Risk of Worsening in the Adult Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-traumatic Medical Emergency

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
337 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control - FRENCH grid only
Arm Type
Active Comparator
Arm Title
FRENCH grid + QuickSOFA
Arm Type
Active Comparator
Arm Title
FRENCH grid + QuickSOFA + Capillary Lactate
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
FRENCH grid (classification for emergency nurses in French hospitals)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
QuickSOFA
Intervention Description
Rapid score that consists of an evaluation based on 3 clinical criteria (blood pressure, respiratory rate and consciousness) to quickly establish a severity score.
Intervention Type
Other
Intervention Name(s)
Capillary lactate assessment
Intervention Description
Collect a drop of blood from the fingertip (less than 1 ml)
Primary Outcome Measure Information:
Title
Waiting time in minutes between contact with the triage nurse and the first medical contact in the emergency room
Time Frame
At inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients admitted to the Dijon-Bourgogne University Hospital emergency room between 1:00 pm and 6:00 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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geoffrey GALOPIN
Phone
0613955677
Email
geoffrey.galopin@chu-dijon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Clément ROUXEL
Phone
0633714808
Email
clement.rouxel@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffrey GALOPIN
Phone
0613955677
Email
geoffrey.galopin@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Clément ROUXEL
Phone
0633714808
Email
clement.rouxel@chu-dijon.fr

12. IPD Sharing Statement

Learn more about this trial

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

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