Non-invasive Intracranial Pressure Estimation by Measurement of the Occlusion Pressure of the Isolated Periorbital Vein (NICE-ICP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, evaluated by incidence of reported adverse events
研究概览
简要总结
Elevated intracranial pressure is a common complication of brain injury which means that the pressure within the skull rises above normal levels. The negative impact of increased intracranial pressure (ICP) on the prognosis of patients has been strongly shown in numerous studies and ICP-based treatment is associated with an important reduction of risk of death. Invasive ICP measurement methods are nowadays a standard of care in severe brain injury. The two available ways of measuring ICP require neurosurgical procedure to implant a catheter and probes within the brain and present risks and complications for the patient, such as infections and intracranial bleeding. In addition, invasive recording of ICP requires neurosurgical expertise and intensive care unit (ICU) facilities, limiting the application of ICP measurements to patients of the acute neuro-ICU (neuro-Intensive Care Unit) with acute brain damage requiring close surveillance to prevent further deterioration of neural tissue and disability. Non-invasive ICP monitoring benefits include no risk of complications seen in invasive monitoring, helping in deciding which patient needs invasive ICP monitoring, and providing ongoing long-term measurements of ICP without having to insert a new device every time. Although many non-invasive ICP measurement methods have been explored, to date, none of them have shown clinical success or usefulness. One under-explored window to ICP is the orbital vein, a small blood vessel located near your eye, which we think could provide a direct link to the intracranial pressure. The study device, called the CPMX3 system, is a non-invasive method to measure pressure in a superficial periorbital vein.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Male or female
- •Age > 18
- •Equipped with an invasive ICP monitor as part of standard of care
排除标准
- •Presence of facial and/or skull trauma that could hinder placement of the pneumatic mask or contraindicate ultrasound on the forehead
- •History of recent cranial surgery or hemicraniectomy
- •Active bleeding (proven or suspected)
- •History or known pathological condition or injury linked to the orbital socket influencingvenous outflow (e.g. Grave disease, tumor, inflammation, trauma, glaucoma, etc.)
- •History, or known vein stenosis in ophthalmic veins/cavernous sinus
- •Any other condition that would interfere with measurement technique and routine clinical care according to the judgment of the investigator.
结局指标
主要结局
Safety of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, evaluated by incidence of reported adverse events
时间窗: up to 7 days
Safety of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, evaluated by incidence of reported Device Deficiencies (DDs)
时间窗: Up to 7 days
Safety of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, evaluated by incidence of reported Serious Adverse Device Effects (SADEs)
时间窗: Up to 7 Days
Preliminary accuracy of venous pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP, measured in mmHg
时间窗: up to 7 days
Preliminary accuracy will be assessed by recording paired measurements of venous occlusion pressure of the periorbital vein when isolated from its surrounding network and invasive ICP measurements from the standard of care invasive ICP monitor in mmHg
次要结局
- Feasibility of finding and compressing the target periorbital vein as reported by the investigator using a visual analog scale 0 to 3(up to 7 days)
- The tolerability of the non-invasive measurement process, evaluated via a dedicated patient questionnaire on patient comfort(up to 7 days)