Skip to content

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03795896
Enrollment
80
Registered
2019-01-08
Start date
2018-09-01
Completion date
2019-11-01
Last updated
2019-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

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

Interventions

DIAGNOSTIC_TESTOptic 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

Sponsors

Mansoura University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

No masking

Intervention model description

prospective observational study

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessing the changes in the intracranial pressurefrom 20 minutes before mannitol therapy (basal reading) till 48 hours after the end of mannitol infusionIt 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

Secondary

MeasureTime frameDescription
Assessing the changes in the heart ratefrom 20 minutes before mannitol therapy (basal reading ) till 48 hours after the end of mannitol infusionIt 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
Assessing the changes in the mean arterial pressurefrom 20 minutes before mannitol therapy(basal reading) till 48 hours after the end of mannitol infusionIt 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026