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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02240394
Other study ID # Shanghai6thPeoplesH
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 3, 2014
Last updated February 10, 2015
Start date March 2014
Est. completion date March 2015

Study information

Verified date February 2015
Source Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Contact n/a
Is FDA regulated No
Health authority China: Science and Technology Commission of Shanghai Municipality
Study type Observational

Clinical Trial Summary

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.


Description:

2014/08/28


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
China NCU ShangHai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Ragauskas A, Matijosaitis V, Zakelis R, Petrikonis K, Rastenyte D, Piper I, Daubaris G. Clinical assessment of noninvasive intracranial pressure absolute value measurement method. Neurology. 2012 May 22;78(21):1684-91. doi: 10.1212/WNL.0b013e3182574f50. Epub 2012 May 9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other the change of the Ophthalmic artery end diastolic velocity associated with intracranial pressure "up to 6 months" Yes
Primary Ophthalmic artery blood flow rate changes associated with intracranial pressure "up to 6 months" Yes
Secondary the change of the Ophthalmic artery peak sistolic velocity associated with intracranial pressure "up to 6 months" Yes
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