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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Brain Electrical Impedance; Non-invasive Intracranial Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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mannitol empirical therapy

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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 Electrical impedance tomography monitoring.

Group Type EXPERIMENTAL

EIT monitoring

Intervention Type DEVICE

non-invasive ICP 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.

Group Type OTHER

non-invasive ICP monitoring

Intervention Type DEVICE

Interventions

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EIT monitoring

Intervention Type DEVICE

non-invasive ICP monitoring

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No