Non-invasive Neuromonitoring Through Point-of-care Determination of ONSD and Assessment of Dynamic Properties of the Optic Nerve Sheath in a Neurointensive Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sonographic monitoring of optic nerve sheath
研究概览
简要总结
Intensive care patients with established invasive intracranial neuromonitoring due to neurotrauma are subjected to a repeated non-invasive sonographic recording of the optic-nerve-sheath-diameter (ONSD). The recorded images are analyzed through a machine-learning-algorithm and an experienced ultrasound operator. Results are correlated to the parallel recorded intracranial pressure (ICP). The study aims to establish ONSD as a supplementary for raised ICP.
详细描述
During the intensive care stay, patients with implemented invasive intracranial pressure monitoring will have sonographic recording of the optic nerve sheath (video clip) with a parallel recording of the underlying ICP. The obtained image material is then i) analyzed by a machine-learning algorithm and ii) manually by 2 blinded differently experienced examiners (expert, novice) with respect to the ONSD. For the manual procedure, three individual measurements are made for each eye and the mean value is determined.
Subsequently, the measured values of the two examiners and the automated procedure are correlated with the ICP recorded during the sonographic examination.
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
- •Traumatic or non-traumatic (e.g. SAH) brain injury
- •Established invasive intracranial pressure monitoring (either intraparenchymal or Intraventricular)
排除标准
- •Soft tissue damage to orbital or periorbital region
- •Fracture of the Orbita
- •Status post decompressive craniectomy
研究组 & 干预措施
Pathologic and non-pathologic intracranial pressure
Sonographic determination of Optic nerve sheath. Parallel recording of ICP
干预措施: Sonographic determination of the optic nerve sheath diameter (Diagnostic Test)
结局指标
主要结局
Sonographic monitoring of optic nerve sheath
时间窗: Single measurement post-trauma up to day 10
Repeated ultrasound-based measurement of optic nerve sheath in millimeter (mm)
次要结局
- Invasively measured intracranial pressure(Continuously from time of admission up to day 10)