NCT04515212已完成不适用
In-Field Detection of Acute Intracranial Hemorrhage Requiring Urgent, Life-Saving Treatment in Severe Traumatic Brain Injury (TBI) Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Optic nerve sheath diameter
研究概览
简要总结
This is a research study to develop a noninvasive test using ultrasound to determine when urgent, life-saving treatment is needed for those with severe traumatic brain injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 or older
- •Able to provide legally effective consent
- •Healthy Volunteer
排除标准
- •Intracranial disease, neurologic symptoms, or eye pathology
- •Patient Inclusion Criteria:
- •Adults age 18 or older
- •Confirmed or suspected severe traumatic brain injury
- •Able to provide legally effective consent
- •Patient Exclusion Criteria:
- •Significant bilateral ocular trauma
结局指标
主要结局
Optic nerve sheath diameter
时间窗: Approximately 10 minutes at the time of ultrasounds
Develop software that will automatically measure optic nerve sheath diameter by analyzing the radio frequency data from an ultrasound probe intervention from those that do not, we will measure the optic nerve sheath diameter manually in the cross-sectional images.
次要结局
未报告次要终点
研究者
研究点 (2)
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