Assessment of the Benefit of an Inclusive Health Organization on the Prognosis of Severe Trauma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,193
- 试验地点
- 1
- 主要终点
- 28-day mortality
研究概览
简要总结
Appropriate management reduces the mortality of severe trauma victims. This is based on a pre-hospital medical assessment of severity, the initiation of life-saving treatments at the pre-hospital level, and referral to a hospital with human and material resources adapted to the patient's severity. The objective of this research project is to show that the 28-day mortality after severe trauma is lower in a structured health system, compared to a non-structured system.
详细描述
Appropriate management reduces the mortality of severe trauma victims defined by an Injury Severity Score (ISS) greater than 15 or the need for specialized and/or urgent treatment. This is based on a pre-hospital medical assessment of severity, the initiation of life-saving treatments at the pre-hospital level, and referral to a hospital with human and material resources adapted to the patient's severity.
The trauma hospital organisation in France is of the "exclusive" type. It contrasts trauma centres with other hospitals, only providing care for severe trauma victims in the former, which are most often confused with university hospitals. The choice of referral to this type of centre is made using a triage algorithm known as "de Vittel". In addition to an insufficient network within a region leading to longer hospital access time, this organisation leads to saturation of the referral centres by patients with few lesions. For this reason, this organisation has been rethought in an innovative way within the Auvergne-Rhône-Alpes region, in favour of an "inclusive" system that takes the form of a network of hospitals with capacities to receive severely traumatised patients that vary according to their equipment and personnel. Patients are referred within this network according to their severity category (unstable, stabilized or stable).
The main objective is to show that the 28-day mortality of severely traumatized persons oriented according to their severity in an inclusive system is lower, at identical severity, than in a conventional exclusive system in which the orientation is guided by the Vittel algorithm.
Secondary objectives are to show that the management of severe traumatized persons oriented according to their severity in an inclusive system, compared to the management in an exclusive conventional system in which the orientation is guided by the Vittel/ASCOTT algorithm, is associated, at identical severity, with :
- Less under-triage;
- Less over-triage;
- A lower incidence of secondary transfers to a trauma center;
- A greater number of days living without mechanical ventilation (during the first 28 days);
- More days living without resuscitation (within the first 28 days);
- More frequent and rapid use of whole-body CT scans with contrast injection;
- More frequent and rapid use of specialized emergency therapies (laparotomy or hemostasis thoracotomy, embolization, craniectomy, intracranial pressure measurement, chest drainage).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients cared for in the aftermath of a severe trauma, by a pre-hospital medical team regulated by the territorially competent SAMU, who arrived at the hospital alive.
排除标准
- •Age < 18 years
- •Patients with no signs of life on hospital arrival and reported deceased within 30 minutes of admission
- •Patients with severe burns (>10% skin area burned)
研究组 & 干预措施
hierarchized
Structured regional health organization, composed of trauma centers hierarchized in several levels according to their capacity to receive severe traumatized persons.
干预措施: Triage (Other)
all-or-nothing
Structured regional health organization, composed of non-hierarchical trauma centers at different levels according to their capacity to receive severe trauma victims (all-or-nothing type).
结局指标
主要结局
28-day mortality
时间窗: 28th day
The primary endpoint will be 28-day mortality, defined as the occurrence of death from any cause within the first 28 days following trauma.
次要结局
- Modalities of the post-traumatic injury assessment by CT scan(first 24 hours of hospitalization)
- Need for and timing of hemostasis thoracotomy(28th day)
- Length of stay in resuscitation(28th day)
- Over-triage(28th day)
- Days living without resuscitation(28th day)
- Modalities of the post-traumatic injury assessment by chest X-ray(first 24 hours of hospitalization)
- Modalities of the post-traumatic injury assessment by pelvis X-ray(first 24 hours of hospitalization)
- Undertriage(28th day)
- Transfer to a trauma centre(1 day)
- Days living without mechanical ventilation(28th day)
- Modalities of the post-traumatic injury assessment by abdominal ultrasound(first 24 hours of hospitalization)
- Modalities of the post-traumatic injury assessment by transcranial Doppler scan(first 24 hours of hospitalization)
- Modalities of the post-traumatic injury assessment by bone radiographs(first 24 hours of hospitalization)
- Need for and timing of laparotomy(28th day)
- Secondary inter-hospital transfer(28th day)
- Distance to the nearest available pre-hospital medical facility(1 day)
- Length of mechanical ventilation(28th day)
- Need for and timing of embolization(28th day)
- Need for and timing of intracranial pressure measurement(28th day)
- Need for and timing of craniectomy(28th day)
- Need for and timing of chest drainage(28th day)
- Length of hospital stay(28th day)