Ocular Ultrasonography as a Tool for Monitoring the Management of Traumatic Brain Injury

NCT ID: NCT03795896

Last Updated: 2019-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-11-01

Brief Summary

Raised intracranial pressure (ICP) is a common and life threatening condition especially in patients with traumatic brain injury.There are many methods for monitoring the increased (ICP) either invasive or non- invasive ,but the gold standard is invasive method. Optic nerve sheath ultrasonography provides a very promising bedside tool for detection of increased ICP. This study will monitor the dynamic changes of intracranial pressure by optic nerve sheath diameter (ONSD) in response to mannitol osmotherapy

Detailed Description

Traumatic brain injury is the main cause of increased intracranial pressure (ICP) in the intensive care .

There are multiple methods for monitoring the raised ICP either invasive or non-invasive.The gold standard is the invasive devices because it is more accurate and reliable .However ,it requires a surgical intervention which has many hazards such as (infection ,hemorrhage,malfunction ).

Optic nerve sheath ultrasonography is a promising bedside tool for detection of increased ICP. The optic nerve is surrounded by cerebro-spinal fluid ,thus if the circulation of cerebro-spinal fluid not blocked ,an increase in ICP will be transmitted through the subarachnoid space around the optic nerve within the nerve sheath especially the retro-bulbar segment.

The study will be conducted to monitor the dynamic changes of intracranial pressure by optic nerve sheath diameter (ONSD) in response to mannitol osmotherapy as a primary outcome and secondary to evaluate the efficacy of ONSD in assessing the severity of the disease

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Optic nerve sheath diameter

The intracranial pressure will be measured by optic nerve sheath diameter while the patient in supine position with 30 -degree bed position .The linear probe in the two -dimensional mode will be placed gently on the upper eyelid without pressure .In linear horizontal orientation for both right and left optic nerve sheath will be measured

Group Type: EXPERIMENTAL

Optic nerve sheath diameter

Intervention Type: DIAGNOSTIC_TEST

The intracranial pressure will be measured by the optic nerve sheath diameter and after giving the mannitol osmotherapy the intracranial pressure will be monitored by the optic nerve sheath diameter

Interventions

Optic nerve sheath diameter

The intracranial pressure will be measured by the optic nerve sheath diameter and after giving the mannitol osmotherapy the intracranial pressure will be monitored by the optic nerve sheath diameter

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

ONSD

Eligibility Criteria

Inclusion Criteria

• Patients with traumatic brain injury

Exclusion Criteria

• Patients with history of optic neuritis
• past history of eye trauma
• patient with optic nerve trauma
• patient with history of arachnoid cyst of the optic nerve
• high myopic patients
• patients with cavernous sius mass

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Abdelraouf Elsharkawy

Lecturer of anesthesia and surgical intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Reem Abdelraouf Elsharkawy

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

Ms/15.05.88

Identifier Type: -

Identifier Source: org_study_id