Comparison of Image Quality Between Ultra-low Dose (ULD) and Standard Dose CT Scans in Detecting Traumatic Brain Injury in the Emergency Room
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Image quality of ultra-low dose scan compared to classic dose for visualising the ventricular system
研究概览
简要总结
Head trauma is a frequent reason for consultation in the emergency room. The CT scan is the reference examination allowing rapid management of the patient. However, CT examinations are among the diagnostic examinations with the highest exposure to ionizing radiation. The study investigators have previously implemented "ultra-low dose" (ULD) acquisitions for several pathologies with an effective dose level similar to that of a standard radiographic examination. These ULD acquisitions are now routinely used in our clinical practice for explorations of the thorax, spine, pelvis and proximal femurs, extremities.
This study expands these ULD acquisitions to skull CT for detecting traumatic intracranial lesions.
The study investigators hypothesize that it would be possible to search for intracranial lesions in patients with head trauma using ULD protocols, thereby reducing the doses delivered to the patient while maintaining sufficient image quality for the diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presenting to the emergency room of the CHU of Nîmes for a cranial trauma requiring scanning.
- •Patient with isolated head injury or polytrauma patient with head injury among others.
- •The patient or their legal representative or family member must have given their free and informed consent and signed the consent form, or the patient was included under an emergency situation
- •The patient must be a member or beneficiary of a health insurance plan
排除标准
- •The subject is participating in a study prohibiting participation in other studies, or is in a period of exclusion determined by a previous study
- •Patient is pregnant, parturient or breastfeeding
结局指标
主要结局
Image quality of ultra-low dose scan compared to classic dose for visualising the ventricular system
时间窗: Day 0
5-point scale: unacceptable, sub-optimal, acceptable, better than average
Image quality of ultra-low dose scan compared to classic dose for visualising deconvexed subarachnoid spaces
时间窗: Day 0
5-point scale: unacceptable, sub-optimal, acceptable, better than average
Image quality of ultra-low dose scan compared to classic dose for visualising the differentiation of grey/white matter
时间窗: Day 0
5-point scale: unacceptable, sub-optimal, acceptable, better than average
Image quality of ultra-low dose scan compared to classic dose for visualising basal cisterns
时间窗: Day 0
5-point scale: unacceptable, sub-optimal, acceptable, better than average
Image quality of ultra-low dose scan compared to classic dose for visualising lenticular nuclei
时间窗: Day 0
5-point scale: unacceptable, sub-optimal, acceptable, better than average
次要结局
- Inter-evaluator concordance (senior versus junior) in visualizing all five structures (differentiation of grey/white matter, lenticular nuclei, ventricular system, basal cisterns, deconvexed subarachnoid spaces)(Day 0)
- Presence of at least one intraparenchymal hemorrhage by ultra-low dose versus classical scanner(Day 0)
- Radiologist-reported image quality of ultra-low dose versus classical scanner(Day 0)
- Presence of at least one subdural hematoma by ultra-low dose versus classical scanner(Day 0)
- Radiologist-reported diagnostic quality of ultra-low dose versus classical scanner(Day 0)
- Presence of at least one subarachnoid hemorrhage by ultra-low dose versus classical scanner(Day 0)
- Presence of at least one cranial bone lesion by ultra-low dose versus classical scanner(Day 0)
- Presence of at least one extradural hematoma by ultra-low dose versus classical scanner(Day 0)
- Presence of at least one bone lesion by ultra-low dose versus classical scanner(Day 0)
- Presence of at least one intracranial hemorrhage by ultra-low dose versus classical scanner(Day 0)
- Radiologist-reported confidence level of ultra-low dose versus classical scanner(Day 0)
- Interpretation time of ultra-low dose versus classical scanner for a senior and junior evaluator(Day 0)