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

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

    • Shanghai
      • ShangHai, Shanghai, China, 200030
        • NCU

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:

  1. age 18-75 years of age (including 18 and 75 years), gender, ethnic limitation;
  2. have been carried out invasive intracranial pressure monitoring;
  3. the patient or his agent informed consent. -

Exclusion Criteria:

  1. the patient does not fit, measured by TCD can not be completed;
  2. TCD failed to detect the satisfaction of the ophthalmic artery flow signals were;
  3. 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

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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