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

NCT03795896 | Unknown

• 1 other identifier: Ms/15.05.88
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Assessing the changes in the heart rate

  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

  from 20 minutes before mannitol therapy(basal reading) till 48 hours after the end of mannitol infusion

Study Arms (1)

Optic nerve sheath diameter

EXPERIMENTAL

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

Interventions

Optic nerve sheath diameter 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

Also known as: ONSD

Optic nerve sheath diameter

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with traumatic brain injury

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Reem Abdelraouf Elsharkawy

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and surgical intensive care

Model Details: prospective observational study

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: January 8, 2019
• Study Start: September 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 8, 2019

Record last verified: 2019-01

Locations

EG (1)