- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02240394
TCD Detection of Ophthalmic Artery Blood Flow Velocity Prediction Feasibility Study of Intracranial Pressure
February 10, 2015 updated by: Xueming Wang, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Increased intracranial pressure is a cause of disease progression in patients with brain disease, a common cause of poor prognosis.
Intracranial pressure monitoring is the observation of the disease, treatment, evaluation and important way to improve the prognosis.
Non-invasive intracranial pressure monitoring can be used to stroke, intracranial hemorrhage, brain trauma, encephalitis and other patients.
Ophthalmic artery originated from the internal carotid artery, the optic canal into the orbit, the entire process can be divided into intracranial optic tube segment and orbital segment.
investigators' preliminary experiments show that when intracranial pressure, intracranial ophthalmic artery segment velocity increases with increasing velocity difference orbital segment.
Accordingly, the investigators speculate, may be judged by the level of intracranial pressure intracranial and orbital velocity difference between the ophthalmic artery segment, and accordingly calculate the specific values of intracranial pressure.
The investigators will collect brain trauma surgery, performed invasive intracranial pressure monitoring cases, the use of transcranial Doppler ultrasound velocity and different segments of the ophthalmic artery pulsatility index, the invasive intracranial pressure and comparing the measured values to calculate the the critical value of the ophthalmic artery segment intraorbital and intracranial velocity difference when intracranial pressure, thus fitting Based on projections of mathematical formulas intracranial pressure.
This study will provide a non-invasive intracranial pressure monitor new approach.
Study Overview
Status
Unknown
Detailed Description
2014/08/28
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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ShangHai, Shanghai, China, 200030
- NCU
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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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Traumatic brain injury patients has been in patients with invasive intracranial pressure monitoring
Description
Inclusion Criteria:
- age 18-75 years of age (including 18 and 75 years), gender, ethnic limitation;
- have been carried out invasive intracranial pressure monitoring;
- the patient or his agent informed consent. -
Exclusion Criteria:
- the patient does not fit, measured by TCD can not be completed;
- TCD failed to detect the satisfaction of the ophthalmic artery flow signals were;
- patients with ocular trauma or a history of intraocular pressure -
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ophthalmic artery blood flow rate changes associated with intracranial pressure
Time Frame: "up to 6 months"
|
"up to 6 months"
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the change of the Ophthalmic artery peak sistolic velocity associated with intracranial pressure
Time Frame: "up to 6 months"
|
"up to 6 months"
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the change of the Ophthalmic artery end diastolic velocity associated with intracranial pressure
Time Frame: "up to 6 months"
|
"up to 6 months"
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wang X Ming, Dr., World Health Organization
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
March 1, 2014
Primary Completion (Anticipated)
March 1, 2015
Study Completion (Anticipated)
March 1, 2015
Study Registration Dates
First Submitted
September 3, 2014
First Submitted That Met QC Criteria
September 12, 2014
First Posted (Estimate)
September 15, 2014
Study Record Updates
Last Update Posted (Estimate)
February 11, 2015
Last Update Submitted That Met QC Criteria
February 10, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Brain Injuries
- Hemorrhage
- Brain Injuries, Traumatic
- Cerebral Hemorrhage
- Intracranial Hypertension
Other Study ID Numbers
- Shanghai6thPeoplesH
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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