Brain Electrical Impedance;EITNCT02027857
Comparison of the Application in Traumatic Brain Edema Between EIT and Non-invasive ICP Monitoring
A study testing EIT monitoring and non-invasive ICP monitoring in people with Brain Electrical Impedance; and Non-invasive Intracranial Pressure, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Brain Electrical Impedance;, Non-invasive Intracranial Pressure
- What is being tested?
- EIT monitoring and non-invasive ICP monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Hu Shijie, M.D.,Ph.D., 086-29-84773307, hushijie@fmmu.edu.cn
Fei Zhou, M.D.,Ph.D., 086-13992888996, feizhou@fmmu.edu.cn
About this study
Official title: 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.
- Being tested
- EIT monitoring, non-invasive ICP monitoring
- Keywords
- brain electrical impedance;, traumatic brain injury;, brain edema;, intracranial pressure
- Medical subject headings
- Brain Injuries, Traumatic, Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIT monitoringDevice
non-invasive ICP monitoringDevice
| Study group | Role | What they receive |
|---|---|---|
| mannitol empirical therapy | No intervention | 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. |
| EIT monitoring | Experimental | 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. Receives: Device: EIT monitoring |
| non-invasive ICP monitoring | Other | 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. Receives: Device: non-invasive ICP monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain electrical impedance
After the patients' enrollment, the electrodes would be placed properly and the continuous monitoring of brain impedance just be started.
Measured: From the 1st day (enrollment) to the 7th day
Secondary outcomes (9)
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).
Measured: 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.
Measured: 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.
Measured: On the 1st day, 3rd day, 5th and 7th day
Physiological and pathological reflex check
Measured: 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.
Measured: on the 1st and 7th day
non-invasive intracranial pressure
This equipment can continuously monitor the change of intracranial pressure since the patients' enrollment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: the patients were discharged or the 7th day after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Electrical Impedance;Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Zhou, M.D.; Ph.D., Study director, Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027857
- Sponsor's protocol ID
- 20131211-8
- Acronym
- EIT
- Status last verified
- Jan 2014
- First submitted
- 23 Dec 2013
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Application in Traumatic Brain Edema Between Electrical Impedance Tomography and Non-invasive Intracranial Pressure Monitoring
- ClinicalTrials.gov ID
- NCT02027857
- Acronym / sponsor ID
- EIT / 20131211-8
- Keywords
- brain electrical impedance;, traumatic brain injury;, brain edema;, intracranial pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mannitol empirical therapy | No intervention | –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. |
| EIT monitoring | Experimental | Device: EIT monitoringThere 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 | Other | Device: non-invasive ICP monitoringThere 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. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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 .
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EIT monitoring | Device | EIT monitoring |
| non-invasive ICP monitoring | Device | non-invasive ICP monitoring |
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.
9 secondary outcomes
Glasgow coma scale(GCS)
Time frame: on the 0 day of the study
demographic characteristics at baseline
Time frame: on the 0 day of the study
kidney function examination
Time frame: On the 1st day, 3rd day, 5th and 7th day
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
non-invasive intracranial pressure
Time frame: From the 1st day (enrollment) to the 7th day
brain CT scan
Time frame: On the 1st day (enrollment), and 7th day
Disability Rating Scale (DRS)
Time frame: on the 1st day (enrollment), seventh day after hospitalization
glasgow outcome scale(GOS)
Time frame: the patients were discharged or the 7th day after hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fei Zhou, M.D.; Ph.D. study director
Department of Neurosurgery, Xijing Hospital, Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EIT monitoring and non-invasive ICP monitoring in people with Brain Electrical Impedance; and Non-invasive Intracranial Pressure, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hu Shijie, M.D;Ph.D. (086-29-84773307, hushijie@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain electrical impedance (time frame: From the 1st day (enrollment) to the 7th day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2014.