Clinical trial NCT05401487: Multicentre Study: Adherence to the Severe Trauma Patients Pathway in PACA Region
Official title: Multicentre Study: Adherence to the Severe Trauma Patients Pathway in PACA Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Keywords: severe trauma
PACA ORU recommendations
golden hour
emergency rapid response unit
hospital care
prognosis
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient with a severe trauma requiring SMUR activation

Brief summary: Trauma patient management concerns more than 140,000 patients per year in France. PACA Regional Emergency Observatory (ORU) has issued recommendations to optimize the management of these trauma patients from pre-hospital phase to hospitalization first hours. Ideally, pre-hospital care should not exceed 60 minutes, from accident (first call to the SAMU) to trauma center arrival: the "golden hour" concept. Patients presenting at least one of the Vittel criteria are considered as severely traumatized and are classified according to 3 states of seriousness: unstable, critical and potentially serious. They are referred to trauma centers whose classification is based on their technical facilities, ranging from level 1 (maximum technical facilities) to level 3 (minimum technical facilities). Patients are referred according to their severity, distance from accident site, referral center and availability of each site. Initial hospital management recommends a whole body CT scan within 45 minutes for patients categorized as unstable or critical by pre-hospital doctor and 90 minutes for patients deemed potentially serious.

FILTRAUMA PACA study will analyze the impact of the different management sequences of severe trauma patients based on reliable temporal data because it is automatically incremented in databases and will seek to find a correlation with patient outcome (survival at 24 hours and 28 days).

The main hypothesis tested is that PACA ORU recommended delay respect during trauma patient initial management is correlated with vital prognosis in short (24 hours) and medium terms (28 days).

Detailed description: Trauma patient management concerns more than 140,000 patients per year in France. Grenoble region was the first one to organize its trauma network around trauma centers ranked by levels (from level 1, the most complete technical platform, to level 3). PACA Regional Health Agency (ARS) set up its dedicated line for severe trauma patients in 2014 based on a regional multi-professional group recommendations, the PACA Regional Emergency Observatory (ORU), in order to optimize the management of these trauma patients from pre-hospital phase to hospitalization first hours (recommendations available online: https://ies-sud.fr/bonnes-pratiques/).

This network suggests a care pathway setting objectives at each stage with operating requirements. Ideally, pre-hospital care should not exceed 60 minutes, from accident (first call to the SAMU) to trauma center arrival: the "golden hour" concept. Patients presenting at least one of the Vittel criteria are considered as severely traumatized and are classified according to 3 states of seriousness: unstable, critical and potentially serious. They are referred to trauma centers whose classification is based on their technical facilities, ranging from level 1 (maximum technical facilities) to level 3 (minimum technical facilities). In PACA region, level 1 technical platforms are North Hospital and Timone Hospital (AP-HM, Marseille, 13) and Sainte Anne Hospital (Toulon, 83). Levels 2 are Sainte Musse Hospital (Toulon, 83), Saint Joseph Hospital (Marseille, 13) and Avignon Hospital (84) and levels 3 correspond to all other hospitals in the region. Patients are referred according to their severity, distance from accident site, referral center and availability of each site. Initial hospital management recommends a whole body CT scan within 45 minutes for patients categorized as unstable or critical by the pre-hospital doctor and 90 minutes for patients deemed potentially serious.

FILTRAUMA PACA study will analyze the impact of the different management sequences of severe trauma patients based on reliable temporal data because it is automatically incremented in databases and will seek to find a correlation with patient outcome (survival at 24 hours and 28 days). The main hypothesis tested is that PACA ORU recommended delay respect during trauma patient initial management is correlated with vital prognosis in short (24 hours) and medium terms (28 days).

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Any patient with a severe trauma requiring SMUR activation. Trauma defined by the appearance of a lesion following a fall, a road accident, a burn or the penetration of a foreign body and regulated by one of the PACA region SAMU centres (84, 83, 13, 04)

Exclusion Criteria:

* Opposition of the patient, family member or trusted person
* Patient under legal protection (guardianship or curatorship)

Primary outcomes:
measure: To evaluate whether compliance with the "golden hour", pre-hospital delay recommended by PACA ORU, influences severe trauma patient vital status.
timeFrame: 24 hours
Secondary outcomes:
measure: To evaluate whether adherence to ORU PACA recommendations in terms of pre-hospital management delays influences severe trauma patient vital status at day 28
timeFrame: 28 days
measure: To assess whether transport by suitable vehicle to appropriate health facility recommended by the ORU PACA influences the vital status of severe trauma patients.
timeFrame: 28 days
measure: To assess whether accident categorization and assessment transfer to the SAMU recommended by the ORU PACA influences the vital status of severe trauma patients.
timeFrame: 28 days
measure: To assess whether management on accident scene recommended by the ORU PACA influences the vital status of severe trauma patients.
timeFrame: 28 days
measure: To assess whether overall assessment of severity recommended by the ORU PACA influences the vital status of severe trauma patients.
timeFrame: 28 days
measure: To assess whether time required to perform a whole body CT scan recommended by the ORU PACA influences the vital status of severe trauma patients.
timeFrame: 28 days
measure: To analyze risk factors for non-adherence to recommendations
timeFrame: 28 days
measure: To analyze errors in referring severe trauma patients to an appropriate care facility
timeFrame: 28 days
Other outcomes:
Locations:
city: Digne-les-Bains
country: France
facility: Centre Hospitalier de Digne les Bains
state: Alpes-de-Haute-Provence
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
state: Var
city: Avignon
country: France
facility: Centre Hospitalier d'Avignon Henri Duffaut
state: Vaucluse
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Marc FOURNIER, MD, PhD
role: STUDY_DIRECTOR
References:
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