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临床试验/NCT07414186
NCT07414186尚未招募不适用

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

Centre Hospitalier Sud Francilien1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
400
试验地点
1
主要终点
Mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 15 years (upper age limit for the pediatric population)
  • Severe trauma, defined as any road traffic accident, defenestration, fall from a height greater than 3 meters, stab wound, or ballistic injury requiring medically supervised transport to one of the Level 1 trauma centers in the Île-de-France region
  • Prehospital management provided by one of the SMUR teams in the Essonne department (91)

排除标准

  • Patients declared dead at initial medical contact, without resuscitation initiated, or with resuscitation attempted and subsequently discontinued (non-return of spontaneous circulation)
  • Secondary inter-hospital transfer from another hospital to a Level 1 trauma center
  • Transport to a hospital for local computed tomography imaging only (without direct admission to a Level 1 trauma center)
  • Cases regulated (dispatched) by emergency coordination centers other than the Essonne (91) medical dispatch center

研究组 & 干预措施

Patients managed prehospital by a SMUR team from the Essonne department (91) and transported to a Le

Patients managed prehospital by a SMUR team from the Essonne department (91) and transported to a Level 1 trauma center according to the predefined inclusion criteria.

结局指标

主要结局

Mortality

时间窗: at day 0

All-cause in-hospital mortality within 24 hours

次要结局

  • Length of hospital stay and neurological outcome(Up to one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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