This trial is active, not recruiting.

Conditions traumatic brain injury, cerebral hemorrhage, increased intracranial pressure
Sponsor Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Start date March 2014
End date March 2015
Trial size 400 participants
Trial identifier NCT02240394, Shanghai6thPeoplesH


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Ophthalmic artery blood flow rate changes associated with intracranial pressure
time frame: "up to 6 months"

Secondary Outcomes

the change of the Ophthalmic artery peak sistolic velocity associated with intracranial pressure
time frame: "up to 6 months"

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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 -

Additional Information

Official title TCD Detection of Ophthalmic Artery Blood Flow Velocity Prediction Feasibility Study of Intracranial Pressure
Principal investigator Wang X Ming, Dr.
Description 2014/08/28
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Shanghai Jiao Tong University Affiliated Sixth People’s Hospital.