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临床试验/NCT05588791
NCT05588791招募中不适用

Pertinence de la PREscription du Scanner Corps-Entier Aux Urgences : un Outil d'Identification Des Patients à Bas Risque

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 2,018 人开始时间: 2023年6月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,018
试验地点
1
主要终点
PHASE II: To quantify the effective reduction in SCE requests after the validated score is made available on the SCE prescription vouchers.

研究概览

简要总结

The whole-body scanner (SCE) is a powerful examination that guides the management of patients severely traumatized. However, the systematic use of this examination in emergency departments is responsible for a large proportion of normal examinations. In addition to the non-negligible direct cost, the average irradiation of 20 mSv would give an adult a 1 in 1000 risk of developing a cancer. The Vittel score makes it possible to categorize pre-hospital patients as seriously traumatized to guide the sending of resources and direct them to a center equipped with a suitable technical platform.

The use of this score to condition the prescription of the ECS is at the origin of an over-triage important since one out of two patients who validates at least one criterion has no lesion on imaging. The purpose of this research project is to validate a decision support tool to objectively guide the emergency physician in its use of the ECS. At the same time, the economic impact of such a procedure will be analysed.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Any adult patient undergoing an SCE as part of a post-traumatic lesion assessment during a stay in the emergency room.
  • Mechanism of injury: road accident or fall.
  • Patient having read and understood the information letter and given his oral consent.

排除标准

  • Neurological impairment defined by a Glasgow score of less than
  • Respiratory failure with SpO2 < 90% on oxygen or with the use of ventilatory assistance.
  • Hemodynamic failure with vascular filling greater than 1000 cc or recourse to catecholamines.
  • Acute alcoholism.
  • Taking narcotics.
  • History of cognitive disorders.
  • Current pregnancy.
  • Suicidal patient.
  • Trauma related to a brawl
  • Penetrating trauma.
  • Hemophilia.
  • Known thrombocytopenia at the time of inclusion.
  • Heart, lung, liver or kidney transplant patient.
  • Person deprived of liberty by an administrative or judicial decision or person placed under legal safeguard / sub-tutorship or curatorship.

结局指标

主要结局

PHASE II: To quantify the effective reduction in SCE requests after the validated score is made available on the SCE prescription vouchers.

时间窗: through study Phase 2 completion, an average of 1 year

The main judgment criterion is the prescription of an irrelevant whole-body scanner (a patient whose 15 safety criteria are validated).

PHASE I: Assess the negative predictive value of a 15-criteria score to exclude the traumatized patient from a whole-body CT (SCE) imaging strategy to emergencies.

时间窗: through study Phase 1 completion, an average of 1 year

The main judgment criterion is defined by the uselessness of the whole body scanner, evaluated from the SCE voucher which will contain the 15 criteria from phase I.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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