Clinical Trials Directory

Trials / Completed

CompletedNCT05401487

Multicentre Study: Adherence to the Severe Trauma Patients Pathway in PACA Region

Status
Completed
Phase
Study type
Observational
Enrollment
265 (actual)
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
OTHERPre-hospital and hospital carePre-hospital care not exceeding 60 min and a whole body CT scan within 45 min for patients categorized as unstable or critical by the pre-hospital doctor and 90 minutes for patients deemed potentially serious.

Timeline

Start date
2022-11-23
Primary completion
2024-06-20
Completion
2024-06-20
First posted
2022-06-02
Last updated
2026-04-13

Locations

3 sites across 1 country: France

Source: ClinicalTrials.gov record NCT05401487. Inclusion in this directory is not an endorsement.