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Not Yet RecruitingNCT07414186

Study of Pre Hospital Management of Polytrauma Patients by Medical Teams From a Department in the Parisian Region

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
400 (estimated)
Sponsor
Centre Hospitalier Sud Francilien · Academic / Other
Sex
All
Age
15 Years
Healthy volunteers
Not accepted

Summary

To study the impact of prehospital management duration by SMUR teams in the Essonne department (91) on early patient mortality (within 24 hours) and to analyze the procedures performed on scene. The study hypothesis is that all-cause in-hospital mortality may be associated with the duration of prehospital care, with either a beneficial impact related to the performance of life-saving interventions or a negative impact due to prolonged time to access definitive treatment. Identifying potential factors associated with prolonged prehospital management times could help define possible areas for improvement and future interventions.

Detailed description

Trauma is the leading cause of mortality among individuals aged 25-34 years, regardless of the mechanism of injury (road traffic accidents, falls from height, defenestration, ballistic or stab wounds, etc.). More than 50% of trauma-related deaths occur within the first hour following injury, and over 80% occur within the first 24 hours. Since the 1970s, the principle that definitive treatment should be initiated within one hour of the beginning of medical care for any life-threatening condition has been introduced. This concept, known as the "Golden Hour," has been applied in many fields, including trauma care, with the assumption that any delay is associated with decreased patient survival. In the literature, prehospital time intervals do not consistently demonstrate a clear impact on mortality, with study results often being contradictory (1-11). A French study conducted within a SMUR-type system by Tobias Gauss in 2019 reported a significant linear increase in mortality associated with longer prehospital time (1). In contrast, other American and European studies (3,7) did not find a significant association between prehospital care time and short- or long-term mortality, in healthcare systems that are not always comparable to the French SMUR model. Overall, studies on this topic have yielded heterogeneous and sometimes conflicting results. Nevertheless, these time intervals appear to play a more critical role in patients with penetrating trauma or with initial arterial hypotension. The major challenge in the prehospital setting is therefore to rapidly identify patients for whom prolonged on-scene management would have a detrimental impact on survival. The physician must then determine the optimal amount of time to spend at the scene during SMUR intervention, based on the risk-benefit balance for the patient. Some patients will require longer prehospital management in order to perform life-saving procedures, whereas for others, for whom definitive treatment is exclusively hospital-based, any delay will be unacceptable.

Conditions

Timeline

Start date
2026-03-01
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2026-02-17
Last updated
2026-02-17

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT07414186. Inclusion in this directory is not an endorsement.