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

Not Applicable

• Conditions: Non-invasive Intracranial Pressure; Brain Electrical Impedance;
• Interventions: Device: EIT monitoring; Device: non-invasive ICP monitoring

• Registration Number: NCT02027857
• Lead Sponsor: Xijing Hospital

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 Description

Not available

Study Timeline

• Study First Submitted: 2013-12-23
• Status Verified: 2014-01
• Study Start: 2014-01
• Study First Submitted QC: 2014-01-02
• Last Update Submitted: 2014-01-02
• Study First Posted: 2014-01-06
• Last Update Posted: 2014-01-06
• Primary Completion: 2015-01
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EIT monitoring	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.
non-invasive ICP monitoring	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.

Primary Outcome Measures

Name	Time	Method
brain electrical impedance	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 Outcome Measures

Name	Time	Method
Glasgow coma scale(GCS)	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	on the 0 day of the study	The demographic data include age, gender, injuries reason, time from injuries, and so on.
kidney function examination	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	on the 1st and 7th day
muscular strength and tension test	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	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	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)	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)	the patients were discharged or the 7th day after hospitalization	GOS includes 5 grades: Dead, Vegetative state, Severe disability, Moderate disability, Good recovery.

Trial Locations

Locations (1)

Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an City, Shaanxi, China