An interventional study of EIT monitoring and non-invasive ICP monitoring in Brain Electrical Impedance; and Non-invasive Intracranial Pressure, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-01-06.
Sponsored by Xijing Hospital · Not applicable, Interventional, and Diagnostic
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.
92 studies on the registry are indexed under Brain Edema; 21 are open to participants now.
This study's planned enrollment of 60 is close to the median of 55 across 55 interventional studies indexed under Brain Edema.
Browse Brain Edema studies →Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.
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Exclusion Criteria:
There would be 20 patients in this group, who would be given mannitol to relieve the brain edema depending on the empirical therapy by doctors.
There would be 20 patients in this group, who would be given mannitol to relieve the brain edema depending on the results of Electrical impedance tomography monitoring.
Device: EIT monitoring
There would be 20 patients in this group, who would be given mannitol to relieve the brain edema depending on the results of non-invasive intracranial pressure monitoring.
Device: non-invasive ICP monitoring
brain electrical impedance
After the patients' enrollment, the electrodes would be placed properly and the continuous monitoring of brain impedance just be started.
Time frame: From the 1st day (enrollment) to the 7th day
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).
Time frame: on the 0 day of the study
demographic characteristics at baseline
The demographic data include age, gender, injuries reason, time from injuries, and so on.
Time frame: on the 0 day of the study
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.
Time frame: On the 1st day, 3rd day, 5th and 7th day
Physiological and pathological reflex check
Time frame: on the 1st and 7th day
muscular strength and tension test
There are 6 grades in muscular strength test. And muscular tension test was referred to Modified Ashworth scale.
Time frame: on the 1st and 7th day
non-invasive intracranial pressure
This equipment can continuously monitor the change of intracranial pressure since the patients' enrollment.
Time frame: From the 1st day (enrollment) to the 7th day
brain CT scan
Brain CT scan is applied to monitor the degree and progress of the brain change after the medication of mannitol.
Time frame: On the 1st day (enrollment), and 7th day
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.
Time frame: on the 1st day (enrollment), seventh day after hospitalization
glasgow outcome scale(GOS)
GOS includes 5 grades: Dead, Vegetative state, Severe disability, Moderate disability, Good recovery.
Time frame: the patients were discharged or the 7th day after hospitalization
This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Xijing Hospital