- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02027857
Comparison of the Application in Traumatic Brain Edema Between EIT and Non-invasive ICP Monitoring (EIT)
January 2, 2014 updated by: Xijing Hospital
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
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Shaanxi
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Xi'an City, Shaanxi, China, 710032
- Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University
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Contact:
- Hu Shijie, M.D.,Ph.D.
- Phone Number: 086-29-84773307
- Email: hushijie@fmmu.edu.cn
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Contact:
- Fei Zhou, M.D.,Ph.D.
- Phone Number: 086-13992888996
- Email: feizhou@fmmu.edu.cn
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Principal Investigator:
- Hu Shijie, M.D.,Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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From the 1st day (enrollment) to the 7th day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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on the 0 day of the study
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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.
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on the 0 day of the study
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kidney function examination
Time Frame: On the 1st day, 3rd day, 5th and 7th day
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There are three main indicators: blood creatinine, urea nitrogen, and uric acid.
These indicator are used as a monitor of the kidney safety.
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On the 1st day, 3rd day, 5th and 7th day
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Physiological and pathological reflex check
Time Frame: on the 1st and 7th day
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on the 1st and 7th day
|
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muscular strength and tension test
Time Frame: on the 1st and 7th day
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There are 6 grades in muscular strength test.
And muscular tension test was referred to Modified Ashworth scale.
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on the 1st and 7th day
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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.
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From the 1st day (enrollment) to the 7th day
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brain CT scan
Time Frame: On the 1st day (enrollment), and 7th day
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Brain CT scan is applied to monitor the degree and progress of the brain change after the medication of mannitol.
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On the 1st day (enrollment), and 7th day
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Disability Rating Scale (DRS)
Time Frame: on the 1st day (enrollment), seventh day after hospitalization
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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.
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on the 1st day (enrollment), seventh day after hospitalization
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glasgow outcome scale(GOS)
Time Frame: the patients were discharged or the 7th day after hospitalization
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GOS includes 5 grades: Dead, Vegetative state, Severe disability, Moderate disability, Good recovery.
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the patients were discharged or the 7th day after hospitalization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Fei Zhou, M.D.; Ph.D., Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20131211-8
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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