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

Primary Purpose

Brain Electrical Impedance;, Non-invasive Intracranial Pressure

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EIT monitoring
non-invasive ICP monitoring
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Electrical Impedance; focused on measuring brain electrical impedance;, traumatic brain injury;, brain edema;, intracranial pressure

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Other

Arm Label

mannitol empirical therapy

EIT monitoring

non-invasive ICP monitoring

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
demographic characteristics at baseline
The demographic data include age, gender, injuries reason, time from injuries, and so on.
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.
Physiological and pathological reflex check
muscular strength and tension test
There are 6 grades in muscular strength test. And muscular tension test was referred to Modified Ashworth scale.
non-invasive intracranial pressure
This equipment can continuously monitor the change of intracranial pressure since the patients' enrollment.
brain CT scan
Brain CT scan is applied to monitor the degree and progress of the brain change after the medication of mannitol.
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.
glasgow outcome scale(GOS)
GOS includes 5 grades: Dead, Vegetative state, Severe disability, Moderate disability, Good recovery.

Full Information

First Posted
December 23, 2013
Last Updated
January 2, 2014
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02027857
Brief Title
Comparison of the Application in Traumatic Brain Edema Between EIT and Non-invasive ICP Monitoring
Acronym
EIT
Official Title
Comparison of the Application in Traumatic Brain Edema Between Electrical Impedance Tomography and Non-invasive Intracranial Pressure Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Electrical Impedance;, Non-invasive Intracranial Pressure
Keywords
brain electrical impedance;, traumatic brain injury;, brain edema;, intracranial pressure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mannitol empirical therapy
Arm Type
No Intervention
Arm Description
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.
Arm Title
EIT monitoring
Arm Type
Experimental
Arm Description
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.
Arm Title
non-invasive ICP monitoring
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EIT monitoring
Intervention Type
Device
Intervention Name(s)
non-invasive ICP monitoring
Primary Outcome Measure Information:
Title
brain electrical impedance
Description
After the patients' enrollment, the electrodes would be placed properly and the continuous monitoring of brain impedance just be started.
Time Frame
From the 1st day (enrollment) to the 7th day
Secondary Outcome Measure Information:
Title
Glasgow coma scale(GCS)
Description
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).
Time Frame
on the 0 day of the study
Title
demographic characteristics at baseline
Description
The demographic data include age, gender, injuries reason, time from injuries, and so on.
Time Frame
on the 0 day of the study
Title
kidney function examination
Description
There are three main indicators: blood creatinine, urea nitrogen, and uric acid. These indicator are used as a monitor of the kidney safety.
Time Frame
On the 1st day, 3rd day, 5th and 7th day
Title
Physiological and pathological reflex check
Time Frame
on the 1st and 7th day
Title
muscular strength and tension test
Description
There are 6 grades in muscular strength test. And muscular tension test was referred to Modified Ashworth scale.
Time Frame
on the 1st and 7th day
Title
non-invasive intracranial pressure
Description
This equipment can continuously monitor the change of intracranial pressure since the patients' enrollment.
Time Frame
From the 1st day (enrollment) to the 7th day
Title
brain CT scan
Description
Brain CT scan is applied to monitor the degree and progress of the brain change after the medication of mannitol.
Time Frame
On the 1st day (enrollment), and 7th day
Title
Disability Rating Scale (DRS)
Description
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.
Time Frame
on the 1st day (enrollment), seventh day after hospitalization
Title
glasgow outcome scale(GOS)
Description
GOS includes 5 grades: Dead, Vegetative state, Severe disability, Moderate disability, Good recovery.
Time Frame
the patients were discharged or the 7th day after hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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. 6. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hu Shijie, M.D;Ph.D.
Phone
086-29-84773307
Email
hushijie@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Hu Shijie, M.D;Ph.D.
Phone
086-13992888996
Email
hushijie1979@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fei Zhou, M.D.; Ph.D.
Organizational Affiliation
Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University
City
Xi'an City
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hu Shijie, M.D.,Ph.D.
Phone
086-29-84773307
Email
hushijie@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Fei Zhou, M.D.,Ph.D.
Phone
086-13992888996
Email
feizhou@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Hu Shijie, M.D.,Ph.D.

12. IPD Sharing Statement

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

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