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

Ocular Ultrasonography in Assessing Severity and Management of Increased Intracranial Pressure in Traumatic Brain Injury

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

Study Overview

• Status: Unknown
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Diagnostic test: Optic nerve sheath diameter

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

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansourah, Dakahlia, Egypt, 35516
      • Reem Abdelraouf Elsharkawy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Diagnostic test: 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; Other Names: ONSD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the changes in the intracranial pressure	It will be monitored and recorded the changes in intracranial pressure to the mannitol therapy .Basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion	from 20 minutes before mannitol therapy (basal reading) till 48 hours after the end of mannitol infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the changes in the heart rate	It will be recorded basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion	from 20 minutes before mannitol therapy (basal reading ) till 48 hours after the end of mannitol infusion
Assessing the changes in the mean arterial pressure	It will be calculated according to the formula systolic blood pressure+2(diastolic blood pressure)recorded basal (before mannitol therapy).20 minutes after the end of mannitol infusion ,2 hours ,6 hours,12 hours ,24 hours and 48 hours after the end of mannitol infusion	from 20 minutes before mannitol therapy(basal reading) till 48 hours after the end of mannitol infusion

Collaborators and Investigators

• Sponsor: Mansoura University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: January 1, 2019
• First Submitted That Met QC Criteria: January 5, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 5, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: Ms/15.05.88

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No