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

NCT02240394 | Unknown DMC

• 1 other identifier: Shanghai6thPeoplesH
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury; Cerebral Hemorrhage; Increased Intracranial Pressure

Keywords

TCD Traumatic brain injury increased intracranial pressure

Outcome Measures

Primary Outcomes (1)

• Ophthalmic artery blood flow rate changes associated with intracranial pressure

  "up to 6 months"

Secondary Outcomes (1)

• the change of the Ophthalmic artery peak sistolic velocity associated with intracranial pressure

  "up to 6 months"

Other Outcomes (1)

• the change of the Ophthalmic artery end diastolic velocity associated with intracranial pressure

  "up to 6 months"

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Traumatic brain injury patients has been in patients with invasive intracranial pressure monitoring

You may qualify if:

• 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. -

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

Study Sites (1)

NCU

Shanghai, Shanghai Municipality, 200030, China

Location

Related 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.

  PMID: 22573638 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Cerebral Hemorrhage; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wang X Ming, Dr.

  World Health Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 15, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 11, 2015

Record last verified: 2015-02

Locations

CN (1)