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

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

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.

Study Overview

• Status: Unknown
• Conditions: Brain Electrical Impedance;; Non-invasive Intracranial Pressure
• Intervention / Treatment: Device: EIT monitoring; Device: non-invasive ICP monitoring

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hu Shijie, M.D;Ph.D.; Phone Number: 086-29-84773307; Email: hushijie@fmmu.edu.cn
• Study Contact Backup: Name: Hu Shijie, M.D;Ph.D.; Phone Number: 086-13992888996; Email: hushijie1979@126.com

Study Locations

• China
  • Shaanxi
    • Xi'an City, Shaanxi, China, 710032
      • Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University
      • Contact: Hu Shijie, M.D.,Ph.D.; Phone Number: 086-29-84773307; Email: hushijie@fmmu.edu.cn
      • Contact: Fei Zhou, M.D.,Ph.D.; Phone Number: 086-13992888996; Email: feizhou@fmmu.edu.cn
      • Principal Investigator: Hu Shijie, M.D.,Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Device: EIT monitoring
Other: 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.	Device: non-invasive ICP monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
brain electrical impedance	After the patients' enrollment, the electrodes would be placed properly and the continuous monitoring of brain impedance just be started.	From the 1st day (enrollment) to the 7th day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Director: Fei Zhou, M.D.; Ph.D., Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: December 23, 2013
• First Submitted That Met QC Criteria: January 2, 2014
• First Posted (Estimate): January 6, 2014

Study Record Updates

• Last Update Posted (Estimate): January 6, 2014
• Last Update Submitted That Met QC Criteria: January 2, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: intracranial pressure; brain electrical impedance;; traumatic brain injury;; brain edema
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Edema
• Other Study ID Numbers: 20131211-8