A Prospective Study to Determine Confounding Factors in the Detection of Intracranial Hemorrhage With the Infrascanner
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Presence of intracranial hemorrhage as indicated by the Infrascanner compared to the result of the CT-scan (gold standard)
研究概览
简要总结
The investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine to positive and negative predictive value of the Infrascanner in these different settings.
详细描述
Infrascanner is a portable device initially designed to detect intracranial hemorrhage in battlefield traumas. Infrascanner uses near infrared spectroscopy to measure cerebral blood flow non-invasively. This is achieved by putting the device against the scalp in 4 different areas (frontal, temporal, parietal, occipital) on the left and right side and by comparing both sides.This allows for the detection of intracranial hemorrhages with a volume upwards of 3.5ml and to a depth of 2.5cm. However, little is known about the influence of other intracranial conditions that could confound the measurements of the Infrascanner (e.g. ischemic stroke, brain surgery, brain tumors,...).
Therefore, the investigators prospectively want to use the Infrascanner in patients with ischemic stroke, patients with brain surgery, patients with brain tumors, patients with intracranial hemorrhage and patients with a normal CT scan of the brain as part of a diagnostic work-up after head trauma or headache to determine the positive and negative predictive value of the Infrascanner in these different settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ischemic stroke diagnosed by clinical examination and CT-scan
- •Patients with a brain tumor diagnosed by clinical examination and CT-scan or MRI
- •Patients with an intracranial hemorrhage diagnosed by clinical examination and CT-scan
- •Patients that have undergone brain surgery
- •Patients with a normal CT-scan of the brain after head trauma
- •Patients with headache complaints and a normal CT-scan of the brain as part of their diagnostic work-up
排除标准
- 未提供
结局指标
主要结局
Presence of intracranial hemorrhage as indicated by the Infrascanner compared to the result of the CT-scan (gold standard)
时间窗: 5 minutes
次要结局
未报告次要终点
研究者
Pascal Vanelderen
Prof. Dr.
Ziekenhuis Oost-Limburg