Clinical trial NCT02027857: Comparison of the Application in Traumatic Brain Edema Between EIT and Non-invasive ICP Monitoring
Official title: Comparison of the Application in Traumatic Brain Edema Between Electrical Impedance Tomography and Non-invasive Intracranial Pressure Monitoring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Electrical Impedance;
Non-invasive Intracranial Pressure
Keywords: brain electrical impedance;
traumatic brain injury;
brain edema;
intracranial pressure
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: brain electrical impedance
timeFrame: From the 1st day (enrollment) to the 7th day
Secondary outcomes:
measure: Glasgow coma scale(GCS)
timeFrame: on the 0 day of the study
measure: demographic characteristics at baseline
timeFrame: on the 0 day of the study
measure: kidney function examination
timeFrame: On the 1st day, 3rd day, 5th and 7th day
measure: Physiological and pathological reflex check
timeFrame: on the 1st and 7th day
measure: muscular strength and tension test
timeFrame: on the 1st and 7th day
measure: non-invasive intracranial pressure
timeFrame: From the 1st day (enrollment) to the 7th day
measure: brain CT scan
timeFrame: On the 1st day (enrollment), and 7th day
measure: Disability Rating Scale (DRS)
timeFrame: on the 1st day (enrollment), seventh day after hospitalization
measure: glasgow outcome scale(GOS)
timeFrame: the patients were discharged or the 7th day after hospitalization
Other outcomes:
Locations:
city: Xi'an City
country: China
facility: Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University
name: Fei Zhou, M.D.; Ph.D.
role: STUDY_DIRECTOR
References: