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临床试验/NCT04973592
NCT04973592Unknown不适用

Evaluation of Professional Practices in the Management of Blunt Abdominal Trauma in Children in the Pediatric Emergency Department of the Nancy's University Hospital Between 2011 and 2020 : Indentify Children at Low Risk of Intra Abdominal Injuries

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年7月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Characteristics of the blunt abdominal trauma studied : Trauma kinetics

研究概览

简要总结

The aim of our study is primarily to evaluate the professional practices over the last years in the pediatric emergencies of the Nancy's Hospital for the BATiC.

This, in order to identify the traumatic mechanisms and the initial clinical elements which would make it possible to detect the patients at low risk of developing visceral lesions. Then, a management could be proposed which would rationalize the use of additional examinations and would favor the monitoring and the clinical reassessment after the initial management of a minor trauma.

The study of the data will then aim to establish a composite score (anamnestic and clinical) of initial evaluation, from which could result a uniform management protocol (clinical, biological and imaging) of the minor BATiC, of the intermediate BATiC and the major BATiC, applicable to pediatric emergencies at the Nancy's Hospital.

详细描述

For children aged 1 to 18, trauma is one of the leading causes of death, ahead of cancer and congenital malformations. The traumatic mechanisms are mainly accidents on public roads (car accidents, two-wheel accidents, accidents involving a pedestrian), sports accidents (especially cycling and horse riding), falls from a high height or onto a blunt object, and intentional or unintentional direct hits. Mortality is mainly correlated with involvement of the skull, thorax and abdomen and there is a clear male predominance (sex ratio 2 to 3 boys / 1 girl).

In France, blunt abdominal trauma in children (BATiC) is a frequent reason for consultation in pediatric emergencies. It accounts for 20 to 30% of childhood trauma, among which 10 to 30% result in potentially life-threatening intra-abdominal injuries (IAI). In order of frequency, the organs most affected are the spleen, the liver, kidneys and the pancreas. Rarely, hollow organs such as the small intestine, the duodenum, the colon, or the stomach can be affected. In rarer occasion, sores of the mesentery may be seen to.

BATiC is opposed to penetrating abdominal trauma, which accounts for only 5 to 15% of abdominal trauma in children. It is frequently part of a multiple trauma defined by "a child who has suffered a trauma whose kinetics are likely to cause at least two lesions, at least one of which can be life-threatening".

While multiple trauma accounts for only 14% of childhood trauma, it is nonetheless the main cause of death after the age of 1. For several years, this has motivated the establishment of emergency treatment protocols under the impetus of the development of "trauma centers". Therefore, polytrauma has well-codified diagnostic criteria and precise and systematic management, applicable to pediatric emergencies. Regarding the isolated BATiC, the management is less unequivocal. Although it is more frequent, BATiC with low or medium kinetics does not benefit from any clear management protocol.

Indeed, the management of a child admitted for BATiC in the pediatric emergency room does not necessarily take into account the traumatic mechanism. The course of action currently adopted involves at least an initial clinical evaluation, sometimes repeated after a period of monitoring. Then it is frequently supplemented by the performance of a blood test and imaging aimed at detecting possible IAI.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient aged 0 to 18 years consulting the Pediatric Emergency Department of the Nancy University Hospital.
  • Primary care
  • Blunt abdominal trauma

排除标准

  • Secondary management
  • Polytrauma
  • Open abdominal trauma / Penetrating wound
  • Polyhandicap
  • Pre-existing major digestive or urinary pathology (single kidney, renal or hepatic transplantation...)
  • Pre-existing hemostasis or hepatic disorders or trauma (inborn or acquired causes)

结局指标

主要结局

Characteristics of the blunt abdominal trauma studied : Trauma kinetics

时间窗: Day 0

low (\< 50km/h) or high (\> 50km/h)

Clinical evaluation : Pain

时间窗: Day 0

visual analog scale : 0 to 10

Clinical evaluation : Type of pain

时间窗: Day 0

pain, defense or contracture

Hemodynamic evaluation : Heart rate

时间窗: Day 0

beat/min

Hemodynamic evaluation : Blood pressure

时间窗: Day 0

mmHg

Hemodynamic evaluation : Respiratory rate

时间窗: Day 0

cycle/min

Characteristics of the blunt abdominal trauma studied : Trauma mechanisms

时间窗: Day 0

fall from a bicycle, a horse, a height, road - belted or unbelted accident, two-wheeler accident, blows inflicted

Clinical evaluation : Location of pain

时间窗: Day 0

9 abdominal quadrants

次要结局

  • Biological examinations : Blood count(Day 0)
  • Surgical advice(Day 0)
  • Demographic criteria of the study population : Age(Day 0)
  • Time to management : Time between trauma and consultation(Day 0)
  • Biological examinations : Liver enzyme(Day 0)
  • Biological examinations : Pancreatic enzyme(Day 0)
  • Biological examinations : Coagulation test(Day 0)
  • Imaging examinations : Imaging findings(Day 0)
  • Orientation(Day 0)
  • Demographic criteria of the study population : Gender(Day 0)
  • Time to management : Management time(Day 0)
  • Biological examinations : Blood group(Day 0)
  • Imaging examinations : Imaging(Day 0)
  • Type of management(Day 0)
  • Second consultation at emergency(30 days)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Julie LIENARD

Doctor Julie Lienard - Pediatrician specialized in visceral surgery

Central Hospital, Nancy, France

研究点 (1)

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