Comparison of the Application in Traumatic Brain Edema Between Electrical Impedance Tomography and Non-invasive Intracranial Pressure Monitoring
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- brain electrical impedance
研究概览
简要总结
Brain edema is the main reason for the disability and lethality in traumatic brain injury, which is the most difficult part of emergency rescue. Recently, there is no medical equipment to monitor the early brain edema in clinic. We have found that Electrical impedance tomography (EIT) can perform the real-time and bedside monitoring of brain electrical impedance after single-dose mannitol treatment, which may be a new strategy for the surveillance of brain edema. In this study, we would like to compare the application in traumatic brain edema between EIT and Noninvasive intracranial pressure (ICP) monitoring, including the progress of brain edema, the relationship between impedance and ICP, and the improvement for the patients' prognosis. EIT would probably be a new image strategy for the treatment of traumatic brain injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients were 16 to 65 years of age with all genders.
- •The patients had been diagnosed as traumatic brain injury during 24 hours before enrollment, with the confirmation of CT or MRI.
- •All the patients had provided written informed consent.
- •The patients were receiving usual inpatient rehabilitation and conservative treatment .
排除标准
- •The patients with indication of operation during the research should be excluded.
- •The patients were assessed as unqualified for the study according to the comprehensive evaluation opinion brought forward by the research team.
结局指标
主要结局
brain electrical impedance
时间窗: From the 1st day (enrollment) to the 7th day
After the patients' enrollment, the electrodes would be placed properly and the continuous monitoring of brain impedance just be started.
次要结局
- Glasgow coma scale(GCS)(on the 0 day of the study)
- demographic characteristics at baseline(on the 0 day of the study)
- kidney function examination(On the 1st day, 3rd day, 5th and 7th day)
- Physiological and pathological reflex check(on the 1st and 7th day)
- muscular strength and tension test(on the 1st and 7th day)
- non-invasive intracranial pressure(From the 1st day (enrollment) to the 7th day)
- brain CT scan(On the 1st day (enrollment), and 7th day)
- Disability Rating Scale (DRS)(on the 1st day (enrollment), seventh day after hospitalization)
- glasgow outcome scale(GOS)(the patients were discharged or the 7th day after hospitalization)