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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Xijing Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Glasgow coma scale(GCS) [ Time Frame: on the 0 day of the study ]
    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).
  • demographic characteristics at baseline [ Time Frame: on the 0 day of the study ]
    The demographic data include age, gender, injuries reason, time from injuries, and so on.
  • kidney function examination [ Time Frame: On the 1st day, 3rd day, 5th and 7th day ]
    There are three main indicators: blood creatinine, urea nitrogen, and uric acid. These indicator are used as a monitor of the kidney safety.
  • Physiological and pathological reflex check [ Time Frame: on the 1st and 7th day ]
  • muscular strength and tension test [ Time Frame: on the 1st and 7th day ]
    There are 6 grades in muscular strength test. And muscular tension test was referred to Modified Ashworth scale.
  • non-invasive intracranial pressure [ Time Frame: From the 1st day (enrollment) to the 7th day ]
    This equipment can continuously monitor the change of intracranial pressure since the patients' enrollment.
  • brain CT scan [ Time Frame: On the 1st day (enrollment), and 7th day ]
    Brain CT scan is applied to monitor the degree and progress of the brain change after the medication of mannitol.
  • Disability Rating Scale (DRS) [ Time Frame: on the 1st day (enrollment), seventh day after hospitalization ]
    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.
  • glasgow outcome scale(GOS) [ Time Frame: the patients were discharged or the 7th day after hospitalization ]
    GOS includes 5 grades: Dead, Vegetative state, Severe disability, Moderate disability, Good recovery.


Original Secondary Outcome: Same as current

Information By: Xijing Hospital

Dates:
Date Received: December 23, 2013
Date Started: January 2014
Date Completion: June 2015
Last Updated: January 2, 2014
Last Verified: January 2014