Development and Testing of a Pediatric Cervical Spine Injury Risk Assessment Tool
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
- 否
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
Julie Leonard
Principal Investigator
Nationwide Children's Hospital
