Brain Electrical Impedance;, Non-invasive Intracranial Pressure
Conditions
Keywords
brain electrical impedance;, traumatic brain injury;, brain edema;, intracranial pressure
Brief summary
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.
Interventions
DEVICEEIT monitoring
DEVICEnon-invasive ICP monitoring
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Eligible patients were 16 to 65 years of age with all genders. 2. The patients had been diagnosed as traumatic brain injury during 24 hours before enrollment, with the confirmation of CT or MRI. 3. All the patients had provided written informed consent. 6\. The patients were receiving usual inpatient rehabilitation and conservative treatment .
Exclusion criteria
1. The patients with indication of operation during the research should be excluded. 2. The patients were assessed as unqualified for the study according to the comprehensive evaluation opinion brought forward by the research team.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| brain electrical impedance | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| muscular strength and tension test | on the 1st and 7th day | There are 6 grades in muscular strength test. And muscular tension test was referred to Modified Ashworth scale. |
| Glasgow coma scale(GCS) | on the 0 day of the study | The scale is composed of three tests: eye, verbal and motor responses. The three values separately as well as their sum are considered. The lowest possible GCS (the sum) is 3 (deep coma or death), while the highest is 15 (fully awake person). |
| demographic characteristics at baseline | on the 0 day of the study | The demographic data include age, gender, injuries reason, time from injuries, and so on. |
| kidney function examination | On the 1st day, 3rd day, 5th and 7th day | There are three main indicators: blood creatinine, urea nitrogen, and uric acid. These indicator are used as a monitor of the kidney safety. |
| Physiological and pathological reflex check | on the 1st and 7th day | — |
| brain CT scan | On the 1st day (enrollment), and 7th day | Brain CT scan is applied to monitor the degree and progress of the brain change after the medication of mannitol. |
| Disability Rating Scale (DRS) | on the 1st day (enrollment), seventh day after hospitalization | The DRS includes measures of eye opening, verbalization, and motor response (derived from the Glasgow Coma Scale); cognitive understanding of feeding, dressing, and grooming; degree of assistance and supervision required; and employability. Scores range from 0 to 29, with higher values indicating greater disability. |
| glasgow outcome scale(GOS) | the patients were discharged or the 7th day after hospitalization | GOS includes 5 grades: Dead, Vegetative state, Severe disability, Moderate disability, Good recovery. |
| non-invasive intracranial pressure | From the 1st day (enrollment) to the 7th day | This equipment can continuously monitor the change of intracranial pressure since the patients' enrollment. |
Countries
China
Contacts
Primary ContactHu Shijie, M.D;Ph.D.
Backup ContactHu Shijie, M.D;Ph.D.
Outcome results
None listed