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NCT Number: NCT06551350

Retrospective Assessment of Referral of a Major Trauma Patient

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

Collection of medical data from MICU intervention file and the medical records of patients at the destination hospital

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.
  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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

  7. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Maryline DELATTRE

CONTACT

[email protected]

+3333130754131

Véronique DA COSTA

CONTACT

[email protected]

+3333130755069

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Official study title

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

Acronym: SAMU-TRAUMAS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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