Validation of Non-Invasive Intracranial Pressure Estimation Using CPMX3 in the Periorbital Vein: A Feasibility Study in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Safety of venous occlusion pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP in pediatric patients.
研究概览
简要总结
Intracranial pressure (ICP) monitoring is indicated in a wide range of neurological diseases. The combination of a linear ultrasound array with an integrated pressure sensor into a single handheld probe (ICP Probe) enables the user to precisely and non-invasively estimate blood pressure in a superficial vein overlying a hard structure. The periorbital vein located on the forehead above the eye is an interesting target since it is an emissary vein, directly connected through valveless vessels to the intracranial venous system. Its pressure might thus reflect intracranial pressure if it can be measured before being equalized by redistribution across the whole facial venous network. The usage of a pneumatic mask able to transiently occlude the site of measurement from the superficial venous network might therefore enable to correlate the venous occlusion pressure (VOP) of the periorbital vein to ICP. To confirm the hypothesis, the current clinical trial will compare measurements made with the CPMX3 system with invasively obtained ICP measures.
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
盲法说明
Investigator performing the pressure measurement with CPMX3 will be blinded from the invasive intracranial pressure value for the duration of measurement with CPMX3
入排标准
- 年龄范围
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent/guardian or alert subject (age 18 or over) capable of giving consent; subject less than 18 and of assent age must give assent to participate if appropriate and required by the institution. If the subjects are incapable of giving assent, then only parent/guardian consent is required
- •Male or female
- •Age: 8 to 21 years of age
- •Equipped with an ICP monitor (intraparenchymal probe or EVD) as part of standard of care
排除标准
- •Presence of facial trauma that could hinder placement of the pneumatic mask or contraindicate ultrasound on the forehead
- •Presence of fractures of the skull
- •Any other condition that would interfere with measurement technique and routine clinical care according to the judgment of the investigator.
研究组 & 干预措施
CPMX3 measurement
干预措施: CPMX3 measurement (Device)
结局指标
主要结局
Safety of venous occlusion pressure of the isolated periorbital vein measured with the CPMX3 System to estimate ICP in pediatric patients.
时间窗: Up to 7 days
\- Safety of the device shall be evaluated by systematically reporting Device Deficiencies (DDs), Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) and by monitoring the frequency and incidence of these events. The practitioner will be asked to identify any new risks arising during the measurements using the investigational device.
次要结局
未报告次要终点