Retrospective Assessment of Referral of a Major Trauma Patient (SAMU-TRAUMAS)

December 4, 2024 updated by: Hôpital NOVO

Retrospective Assessment of Referral of a Major Trauma Patient in Val-d'Oise

The aim of this study is to find out whether major trauma patients from the Val d'Oise are referred to the appropriate trauma centre for their care and to assess the quality of triage within the Val d'Oise department.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In France, the number of major trauma is estimated at between 15,000 and 20,000 per year. It is the leading cause of death in patients under the age of 40, and is a significant source of long-term dependency. Mortality from severe trauma varies depending on the region and the circumstances of the accident. Effective initial care and referral to specialist trauma centres are crucial to improving survival. Access to these centres must be guaranteed throughout France. Trauma centres play a central role in the management of serious trauma patients. They are classified by level, from level I to level III.

The triage process aims to direct the patient to the trauma centre with the appropriate level of care. The challenge is to send the "right patient to the right place at the right time". Over-triage and under-triage are two critical concepts in the management of trauma patients. Over-triage (patients considered to be more seriously injured than they really are) leads to excessive consumption of resources and increases waiting times for patients who really need a level I or II trauma centre. Under-triage (patients considered to be less seriously injured than they really are), is characterised by patients being referred to a trauma centre that is insufficiently equipped for their needs, compromises their chances of survival and recovery. In both cases, the loss of chance for the patient is real.

The aim of this study is to find out whether major trauma patients from the Val d'Oise are referred to the appropriate trauma centre for their care, and to assess the quality of triage within the Val d'Oise department.

Study Type

Observational

Enrollment (Estimated)

461

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients regulated by SAMU 95 with suspected major trauma between the 1st January 2023 and the 31th December 2023.

Description

Inclusion Criteria :

  • Between the 1st January 2023 and the 31th December 2023
  • Regulated by SAMU 95 with suspected major trauma
  • Sending an MCIU
  • At least 1 Vittel criterion*

Exclusion Criteria :

  • Death on site
  • Care by an MICU team outside the 95
  • Minor patients and legal protection

  • Transport refusals

    • Vittel criterion :

      • Physiological variables : Glasgow score < 13 Systolic blood pressure < 90 mmHg O2 saturation < 90%

      • Elements of kinetics : Ejection from a vehicle Other passenger killed in the same vehicle Fall > 6 metres Victim thrown or crushed Overall assessment (deformation of the vehicle, estimated speed, absence of helmet, absence of seatbelt) Blast

      • Anatomical lesions : Penetrating trauma to the head, neck, thorax, abdomen, pelvis, arm or thigh Flail chest Severe burn, smoke inhalation Pelvic fracture Suspected spinal cord injury Amputation of wrist, ankle or above Acute limb ischaemia

      • Pre-hospital resuscitation : Assisted ventilation Filling > 1000 ml with colloids Catecholamines Inflated shock-proof trousers

      • Medical context (to be assessed) : Age > 65 Cardiac or coronary insufficiency Respiratory insufficiency Pregnancy (2nd and 3rd trimesters) Blood crase disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Triage assessment of a major trauma patient
Time Frame: At the end of the study, an average of 9 month

The criterion is the evaluation of the referral of the major trauma patient after post-Medics injury assessment into over, normo and under-triage

The over-triage patient is referred to a level I trauma centre with an Injury Severity Score (ISS) <16

The normo-triage patients are either referred to:

  • a level 1 trauma centre with an ISS >15
  • the local scanner and then to an intensive care unit at the scanner site
  • in the emergency department and then to a surgical unit
  • emergency with a return home afterwards

The under-triage patient is either referred to:

  • the local scanner and then to a level 1 trauma centre
  • initially emergency with hospitalisation in an intensive care or continuing care unit afterwards
At the end of the study, an average of 9 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess if the intervention time is correlated with an under-triage
Time Frame: At the end of the study, an average of 9 month

The correlation will be assessed by the proportion of patients under-triaged during the following hours:

  • 7am to 9am
  • From 6pm to 9pm
  • From 9pm to 7am i.e. the ratio between the number of under-triaged patients and the number of major trauma patients treated during the defined time slots.
At the end of the study, an average of 9 month
Assess if presumed alcohol intoxication is correlated with a higher rate of under-triage
Time Frame: At the end of the study, an average of 9 month
The correlation will be assessed by the proportion of patients under-triaged in patients with suspected alcohol intoxication. Presence of suspected alcohol intoxication assessed clinically i.e. the ratio between the number of under-triaged patients with suspected alcohol intoxication and the total number of major trauma patients
At the end of the study, an average of 9 month
Assess if deliberate toxic poisoning is correlated with a higher rate of under-triage
Time Frame: At the end of the study, an average of 9 month
The correlation will be assessed by the proportion of patients under-triaged in patients with suspected deliberate toxic poisoning. Presence of deliberate toxic poisoning assessed clinically i.e. the ratio between the number of under-triaged patients with suspected deliberate toxic poisoning and the total number of major trauma patients
At the end of the study, an average of 9 month
Assess if the TRENAU grade is predictive in pre-hospital of an appropriate referral following an intra-hospital trauma assessment
Time Frame: At the end of the study, an average of 9 month

The criterion will be assessed by the correlation between TRENAU grade and level of trauma centre for final admission :

TRENAU A in a level 1 trauma centre TRENAU B in a level 2 trauma centre TRENAU C in a level 3 trauma centre The TRENAU grade (Trauma System du Réseau Nord Alpin des Urgences) is used to classify major trauma patients into 3 categories (A, B and C) in the pre-hospital phase, so that they can be referred to the appropriate level of hospital
At the end of the study, an average of 9 month
Assess if the positive Shock-Index is predictive of an appropriate pre-hospital referral to a level 1 trauma centre
Time Frame: At the end of the study, an average of 9 month
The criterion will be assessed by the number of patient with positive Shock-Index (≥ 0.9) at the time of MCIU care referred to a level 1 trauma centre (final admission)
At the end of the study, an average of 9 month
Assess if the positive Shock-Index ( ≥ 0.9 ) is predictive of an intra-hospital blood transfusion
Time Frame: At the end of the study, an average of 9 month
The criterion will be assessed by the number of patient with positive Shock-Index (≥ 0.9) at the time of MCIU care and who have had an intra-hospital blood transfusion
At the end of the study, an average of 9 month
Assess if the MGAP is predictive of an appropriate referral following an intra-hospital trauma assessment
Time Frame: At the end of the study, an average of 9 month

The evaluation criterion will be assessed as follow :

Number of patient with a MGAP between 23 and 29 and an final admission in a level 3 trauma centre Number of patient with a MGAP between 18 and 22 and an final admission in a level 2 trauma centre Number of patient with a MGAP < 18 and an final admission in a level 3 trauma centre The MGAP score (Mechansim, Glasgow, Age, Arterial pressure) can predict the risk of in-hospital death in trauma patients. Three risk groups have been defined: low (23-29 points), intermediate (18-22 points) and high (<18 points).
At the end of the study, an average of 9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital NOVO

Investigators

  • Principal Investigator: Fabrice LOUVET, Hôpital NOVO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

August 9, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRD0924

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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