TCD Detection of Ophthalmic Artery Blood Flow Velocity Prediction Feasibility Study of Intracranial Pressure

Traumatic Brain Injury Clinical Trial

Official title:

TCD Detection of Ophthalmic Artery Blood Flow Velocity Prediction Feasibility Study of Intracranial Pressure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02240394
• Other study ID #: Shanghai6thPeoplesH
• 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

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Hemorrhage
• Increased Intracranial Pressure
• Intracranial Hypertension
• Traumatic Brain Injury

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