Brain Electrical Impedance; Clinical Trial
— EITOfficial title:
Comparison of the Application in Traumatic Brain Edema Between Electrical Impedance Tomography and Non-invasive Intracranial Pressure Monitoring
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.
| Status | Not yet recruiting |
| Enrollment | 60 |
| Est. completion date | June 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| China | Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University | Xi'an City | Shaanxi |
| Lead Sponsor | Collaborator |
|---|---|
| Xijing Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | brain electrical impedance | After the patients' enrollment, the electrodes would be placed properly and the continuous monitoring of brain impedance just be started. | From the 1st day (enrollment) to the 7th day | Yes |
| Secondary | Glasgow coma scale(GCS) | 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). | on the 0 day of the study | Yes |
| Secondary | demographic characteristics at baseline | The demographic data include age, gender, injuries reason, time from injuries, and so on. | on the 0 day of the study | Yes |
| Secondary | kidney function examination | There are three main indicators: blood creatinine, urea nitrogen, and uric acid. These indicator are used as a monitor of the kidney safety. | On the 1st day, 3rd day, 5th and 7th day | Yes |
| Secondary | Physiological and pathological reflex check | on the 1st and 7th day | Yes | |
| Secondary | muscular strength and tension test | There are 6 grades in muscular strength test. And muscular tension test was referred to Modified Ashworth scale. | on the 1st and 7th day | Yes |
| Secondary | non-invasive intracranial pressure | This equipment can continuously monitor the change of intracranial pressure since the patients' enrollment. | From the 1st day (enrollment) to the 7th day | Yes |
| Secondary | brain CT scan | Brain CT scan is applied to monitor the degree and progress of the brain change after the medication of mannitol. | On the 1st day (enrollment), and 7th day | Yes |
| Secondary | Disability Rating Scale (DRS) | 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. | on the 1st day (enrollment), seventh day after hospitalization | Yes |
| Secondary | glasgow outcome scale(GOS) | GOS includes 5 grades: Dead, Vegetative state, Severe disability, Moderate disability, Good recovery. | the patients were discharged or the 7th day after hospitalization | Yes |