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Clinical Trials/NCT02027857
NCT02027857
Unknown
Not Applicable

Comparison of the Application in Traumatic Brain Edema Between Electrical Impedance Tomography and Non-invasive Intracranial Pressure Monitoring

Xijing Hospital1 site in 1 country60 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Electrical Impedance;
Sponsor
Xijing Hospital
Enrollment
60
Locations
1
Primary Endpoint
brain electrical impedance
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
June 2015
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xijing Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Eligible patients were 16 to 65 years of age with all genders.
  • The patients had been diagnosed as traumatic brain injury during 24 hours before enrollment, with the confirmation of CT or MRI.
  • All the patients had provided written informed consent.
  • The patients were receiving usual inpatient rehabilitation and conservative treatment .

Exclusion Criteria

  • The patients with indication of operation during the research should be excluded.
  • The patients were assessed as unqualified for the study according to the comprehensive evaluation opinion brought forward by the research team.

Outcomes

Primary Outcomes

brain electrical impedance

Time Frame: From the 1st day (enrollment) to the 7th day

After the patients' enrollment, the electrodes would be placed properly and the continuous monitoring of brain impedance just be started.

Secondary Outcomes

  • Glasgow coma scale(GCS)(on the 0 day of the study)
  • demographic characteristics at baseline(on the 0 day of the study)
  • kidney function examination(On the 1st day, 3rd day, 5th and 7th day)
  • Physiological and pathological reflex check(on the 1st and 7th day)
  • muscular strength and tension test(on the 1st and 7th day)
  • non-invasive intracranial pressure(From the 1st day (enrollment) to the 7th day)
  • brain CT scan(On the 1st day (enrollment), and 7th day)
  • Disability Rating Scale (DRS)(on the 1st day (enrollment), seventh day after hospitalization)
  • glasgow outcome scale(GOS)(the patients were discharged or the 7th day after hospitalization)

Study Sites (1)

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