Comparison of the Application in Traumatic Brain Edema Between EIT and Non-invasive ICP Monitoring

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Brain Electrical Impedance;; Non-invasive Intracranial Pressure

Treatments: Device: non-invasive ICP monitoring; Device: EIT monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT02027857

20131211-8

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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.

4. 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

mannitol empirical therapy

No Intervention group

Description:

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.

EIT monitoring

Experimental group

Description:

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.

Treatment:

Device: EIT monitoring

non-invasive ICP monitoring

Other group

Description:

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.

Treatment:

Device: non-invasive ICP monitoring