Technology of Intracranial Pressure Estimation by Single-Channel EEG in Brain Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Difference between estimated intracranial pressure and actual intracranial pressure
研究概览
简要总结
If intracranial pressure can be measured non-invasively using single-channel EEG, clinicians will be able to easily monitor changes in intracranial pressure in patients with brain diseases in the clinical setting. Therefore, a more efficient treatment plan can be established and the prognosis of patients with brain disease can be expected to improve in the long term.
详细描述
Study Objectives:
- Accuracy evaluation of single-channel EEG-based estimated intracranial pressure and actual intracranial pressure in patients with brain disease
- It is intended to improve the accuracy by analyzing and upgrading the correlation and concordance of the single-channel EEG-based estimated intracranial pressure compared with the actual intracranial pressure measurement of the patient.
Study design: Multi-center prospective clinical trial
The study procedure was explained to the caregiver of the patient with brain disease admitted to the emergency room or intensive care unit, who was or will be implanted with an intracranial pressure monitoring device and informed consent was obtained.
While the intracranial pressure monitoring device is being applied, EEG data and intracranial pressure data are simultaneously acquired by applying a single-channel EEG.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 years or older
- •Patients have had or are planning to insert an intracranial pressure monitoring device due to brain diseases
- •Emergency room or intensive care unit of the study hospital
排除标准
- •EEG measurement is restricted due to trauma or head deformity
- •The attachment of electrodes for EEG measurement interferes with the standard treatment
- •Patients who do not agree to enroll to this study by patients or caregivers
结局指标
主要结局
Difference between estimated intracranial pressure and actual intracranial pressure
时间窗: through study completion, an average of 1 year
The difference between the estimated intracranial pressure and the actual intracranial pressure is calculated using the previously developed intracranial pressure prediction formula using quantitative EEG parameters.
次要结局
未报告次要终点