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临床试验/NCT05049330
NCT05049330已完成不适用

Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool

Julie Leonard25 个研究点 分布在 1 个国家目标入组 22,444 人开始时间: 2018年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22,444
试验地点
25
主要终点
Develop the Pediatric CSI Risk Assessment Tool in children with blunt trauma using prospective observational data obtained from ED providers

研究概览

简要总结

Cervical spine injuries (CSI) are serious, but rare events in children. Spinal precautions (rigid cervical collar and immobilization on a longboard) in the prehospital setting may be beneficial for children with CSI, but are poorly studied. In contrast, spinal precautions for pediatric trauma patients without CSI are common and may be associated with harm. Spinal precautions result in well-documented adverse physical and physiological sequelae. Of substantial concern is that the mere presence of prehospital spinal precautions may lead to a cascade of events that results in the increased use of inappropriate radiographic testing in the emergency department (ED) to evaluate children for CSI and thus an unnecessary, increased exposure to ionizing radiation and lifetime risk of cancer. Most children who receive spinal precautions and/or are imaged for potential CSI, and particularly those imaged with computed tomography (CT), are exposed to potential harm with no demonstrable benefit. Therefore, there is an urgent need to develop a Pediatric CSI Risk Assessment Tool that can be used in the prehospital and ED settings to reduce the number of children who receive prehospital spinal precautions inappropriately and are imaged unnecessarily while identifying all children who are truly at risk for CSI.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 0-17 years
  • Known or suspected exposure to blunt trauma
  • At least one of the following applies to the patient:
  • Undergoing trauma team evaluation
  • Transported from the scene to participating facility by EMS
  • Undergoing cervical spine imaging at participating facility
  • Transferred to participating facility with cervical spine imaging

排除标准

  • Exposed to solely penetrating trauma (e.g. a gunshot or stab wound)

研究组 & 干预措施

Derivation Cohort

The derivation cohort collected data to derive the clinical decision rule.

Validation Cohort

The validation cohort collected data to validate the clinical decision rule

结局指标

主要结局

Develop the Pediatric CSI Risk Assessment Tool in children with blunt trauma using prospective observational data obtained from ED providers

时间窗: 8/1/2018 - 7/31/2022

Validate the Pediatric CSI Risk Assessment Tool in a separate population of children with blunt trauma using prospective observational data obtained from ED providers

时间窗: 8/1/2020-7/31/2023

Cervical Spine Injury

时间窗: CSI diagnosed within 21 days of emergency department presentation

The primary outcome used to derive and validate the prediction rule is the presence of cervical spine injury (CSI) defined as vertebral fracture, ligamentous injury, intraspinal hemorrhage, or spinal cord injury involving the cervical region of the spine (occiput to the 7th cervical vertebra, including ligaments attaching the 7th vertebrae to the 1st thoracic vertebra) on any c-spine imaging modality, including x-ray, skeletal survey, CT scan, and/or MRI.

次要结局

  • Validate the Pediatric CSI Risk Assessment Tool using prospective observational data obtained from EMS providers.(8/1/2018-7/31/2023)

研究者

发起方
Julie Leonard
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Julie Leonard

Principal Investigator

Nationwide Children's Hospital

研究点 (25)

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