Investigation of a New Window Into Intracranial Pressure: Venous Occlusion Pressure of the Isolated Periorbital Vein
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Venous occlusion pressure measurement (mmHg)
研究概览
简要总结
Elevated intracranial pressure (ICP) occurs when pressure inside the skull rises above normal levels, potentially leading to brain damage or herniation. Monitoring ICP is critical for managing conditions like brain tumors, traumatic brain injury, and stroke. Current ICP monitoring methods are invasive and carry risks, including infection and brain damage. For less severe cases, lumbar puncture is a safer, less invasive alternative. This study explores the potential of a non-invasive method, using venous pressure near the eye, to estimate ICP. The goal is to assess whether the results from this non-invasive approach are similar to the invasive lumbar CSF pressure measurements.
详细描述
Elevated intracranial pressure, also known as intracranial hypertension, is a clinical condition occurring when the pressure within the cranial vault rises above physiological levels, which can eventually lead to reduced cerebral perfusion, ischemia, and potentially fatal brain herniation. Measuring intracranial pressure therefore plays a crucial role in the diagnosis and management of numerous neurological or neurosurgical pathological conditions such as brain tumors, traumatic brain injury, central nervous system infections, ischemic stroke, hydrocephalus and idiopathic intracranial hypertension. The standard of care for intracranial pressure monitoring involves invasive procedures.
This study will attempt to measure intracranial pressure by using venous occlusive pressure measured by non-invasive measurements of the isolated periorbital vein. These non-invasive measurements will be performed in parallel to invasive intracranial pressure (ICP) measurements during the current standard of care diagnostic dynamic CSF testing in patients scheduled to undergo the procedure. In addition to the primary objective, this study will also explore potential relations of the venous occlusion pressure to derivatives of dynamic CSF testing.
During the routine dynamic CSF testing, patients will be lying in the recumbent lateral position throughout the test. During the routine setup and preparation time for the CSF dynamic testing, the patient will be equipped with a pneumatic mask and one cycle of 6 successive compression sonography measurements will be demonstrated once by an investigator (#1). After this, the patient is asked to rate the discomfort of the procedure.
The mask will be deflated for the standard lumbar puncture by the physician (investigator #2). After basic testing of the opening pressure and removal of cerebrospinal fluid if needed, a monitoring and infusion setup will be connected to the lumbar needle to perform the actual dynamic CSF testing monitored by investigator #2 according to clinical routines.
Intermittent non-invasive measurements of the isolated periorbital vein will be performed by investigator #1 at regular pre-defined timepoints during this procedure (20 to 30 timepoints in total per participant), without any modification of the SOP and without impact on its duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical indication to perform routine craniospinal CSF dynamic testing according to standard operative procedures
- •Aged 18-95
- •Willing and able to provide valid signed informed consent
排除标准
- •Patients with any known ongoing, or history of, abnormal CSF communication
- •Patients with any kind of prior intervention for CSF diversion
- •Patients with acute brain damage within the preceding 6 months
- •Patients with transdural surgery within the preceding 6 months
- •Head wounds or hematoma that could hinder access to measurement site
- •Any known pathological condition linked to the orbital socket influencing venous outflow
研究组 & 干预措施
Venous occlusion pressure measurements
干预措施: venous occlusion pressure Measurement (Device)
结局指标
主要结局
Venous occlusion pressure measurement (mmHg)
时间窗: 60 minutes
Mean venous occlusion pressure of one isolated target periorbital frontal vein of 6 consecutive measurements in mmHg (mask inflated) during routine infusion test in recumbent lateral position
intracranial Pressure (ICP) in mmHg
时间窗: 60 minutes
Invasive lumbar intracranial pressure measurements in mmHg (mean over a 1-minute window aligned with start of venous occlusion measurements, in mmHg) during routine infusion test in recumbent lateral position
次要结局
- Measurement of pulse frequency in x/min(60 minutes)
- Measurement of venous occlusive pressure in mmHg(60 minutes)
- Measurement of average systolic ICP in mmHg(60 minutes)
- Measurement of average diastolic ICP in mmHg(60 minutes)
- Relationship of venous occlusion pressure measured in mmHg compared to average ICP-Amplitude in mmHg(60 minutes)
- Measurement of elastance of the craniospinal system measured in ml(60 minutes)
- Measurement of pressure-Volume-Index in ml(60 minutes)
- Measurement of CSF outflow resistance (Rcsf) in mmHg*min/m(60 minutes)
- Measurement of respiration frequency in x/min(60 minutes)
- The diagnostic potential of the non-invasive method for ICP determination(60 minutes)
- Stability of venous occlusion pressure within target vein when isolated.(60 minutes)
- Venous filling pressure with mask inflated compared to mask not inflated.(60 minutes)
- Feasability of finding and compressing the target periorbital vein for the investigators(60 minutes)
- The effect of re-referencing measurements by the baseline venous filling pressure (mask not inflated, horizontal recumbent lateral patient position) correlated to invasive lumbar ICP measurements(60 minutes)
- The tolerability of the mask for the participants(60 minutes)
研究者
Katharina Wolf
Funktionsoberärztin Leiterin der Liquorzirkulations-Ambulanz Fachärztin für Neurologie
University of Freiburg