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临床试验/NCT05726201
NCT05726201已完成不适用

Point-Of-Care Ultrasound (POCUS) As an Early Screening Tool for Diagnosing Skull Fractures In Children With Mild Closed Head Injuries

Assiut University2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2023年7月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
95
试验地点
2
主要终点
main

研究概览

简要总结

This study aims to evaluate the accuracy of POCUS as a screening tool for early diagnosis of skull fractures in children with mild closed head injuries admitted to the emergency department. The results would aid the emergency physicians to speed up the management and reduce the cost of diagnosing skull fractures and TBI.

详细描述

Trauma is defined as a physical injury from an external source. Despite improvements in trauma systems worldwide, trauma continues to be one of the leading causes of death and disability in all age groups, especially the young and middle age groups.Head trauma can result in skull fractures which are a common cause of morbidity and mortality in children. There is a high flow of presentations in the Pediatric Emergency Department (PED) and primary care. Children are more susceptible to head trauma and skull fractures than adults. The child's head size is approximately 18% of the total body surface area in infancy. Compared to an adult skull, the child's skull is thinner and more pliable, thus providing less protection to the brain. The Centers for Disease Control and Prevention in the USA reported 749,000 ED visits for injury to the head in children under the age of 15 years old in 2016. One Up to 8% of children aged 3-17.

The Causes of head injury and skull fractures can be classified into accidental and non accidental injuries. Commonly, head injuries are caused by a fall. Other causes can include motor vehicle accidents (MVA), sports-related injuries, or other direct blows to the head. Occasionally, depressed "ping-pong" fractures can occur in newborns due to injury at birth. Fortunately, the majority (80% to 90%) of head injuries can be classified as mild. Very few injuries are life-threatening or require neurosurgical intervention. The incidence of skull fractures in children following head injury ranges from 2% to 20%, and further epidemiological studies are needed for more accurate incidence and prevalence rates.

Skull fractures are more common in children under the age of 2 years following head trauma. A fracture of the calvarium (skull cap) is more common than one at the base of the skull. Skull fractures can cause many complications, such as skin damage, soft tissue injuries, bone fractures, and brain tissue injuries, which are known as traumatic brain injuries. Traumatic brain injury (TBI), which is defined as a disruption in the normal brain's function, can involve both adults and children, but its pathophysiology and management are different in children.

When the skull is fractured, the dura mater is prone to damage. The dural laceration is common in Diastatic skull fractures and should be diagnosed because of its complications.

Head CT scan, an X-ray-based modality, is widely used to diagnose skull fractures and TBI. Children are more sensitive to ionizing radiation, and the relative risk of cancer is higher in them. Identification of skull fractures in children is clinically relevant because these fractures may need surgical intervention irrespective of the presence of TBI. Skull fractures could be associated with non-accidental trauma, and physicians should always consider this potential association .In addition, skull fractures may need follow-up because linear fractures may predispose children to uncommon but serious complications such as expanding fractures or leptomeningeal cysts. Clinicians must weigh the risk of missing a clinically important skull fracture and potentially associated TBI and the risks associated with performing a CT (i.e., carcinogenic effect, and changes in the cognitive function afterwards).

研究设计

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

入排标准

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

入选标准

  • Age group 2 - 18 years old
  • Both genders
  • Blunt head trauma within 24hours of admission to the ED.
  • Glasgow Coma Scale scores of 10 to
  • Localizing evidence of scalp trauma (cephalohematoma, focal pain, deformity)

排除标准

  • Patients who are less than 2 years old or more than 18 years old
  • Patients with open head wounds
  • Ventricular shunts
  • Bleeding disorders
  • Known brain tumors
  • Pre-existing neurological disorders complicating assessment

结局指标

主要结局

main

时间窗: 3 years

Evaluate the diagnostic accuracy (sensitivity and specificity) of point of-care ultrasound (POCUS) as a screening tool for identifying and early diagnosis skull fractures in children with mild closed head trauma

次要结局

  • Agreement ratio(3 years)
  • PECARN predictive rule(3 years)
  • Incidence(3 years)
  • Computed Tomography Scanning skull(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hala Saad Abdel-Ghaffar. MD

Professor of Anesthesiology and Intensive Care Faculty of Medicine

Assiut University

研究点 (2)

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