Point of Care Optic Nerve Sheath Ultrasound to Assess Intracranial Pressure

Study Overview
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Brief Summary
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Elevated intracranial pressure (ICP) is one of the most common symptoms encountered in a variety of traumatic injuries and diseases. Any tissue swelling within the rigid confines of the skull results in increased ICP, which may lead to life-threatening structural alterations in the brain or cerebral blood flow, thus causing oxygen deprivation and ischemia in the brain. Methods for ICP monitoring can be divided into invasive and noninvasive approaches. In fluid-based systems, external ventricular drainage (EVD) has been considered the gold standard. Clinicians have found several noninvasive methods that can be used as surrogates for invasive methods for ICP measurement. The optic nerve, as part of the central nervous system, is wrapped by the dural sheath. The optic nerve sheath (ONS) is the continuation of the subarachnoid space at the optic nerve, and its tissues are connected with the subarachnoid space. Thus, an increase in ICP results in a corresponding elevation of the ONS diameter (ONSD). Hypertonic solutions such as mannitol and hypertonic saline (HTS) are recommended early in the management of ICH after severe TBI . They provide therapeutic benefit along with a wide therapeutic margin. The most recent BTF guidelines stated although hyperosmolar therapy may lower intracranial pressure, there was insufficient evidence about effects on clinical outcomes to support a specific recommendation, or to support use of any specific hyperosmolar agent.

Official Title
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Sonography of the Optic Nerve Sheath Diameter for Comparison Between the Effects of Continuous Infusion of 3%Hypertonic Saline With Intermittent Boluses Versus in Patients With Traumatic Brain Injury.

Conditions
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Optic Nerve Sheath, Hypertonic Saline

Intervention / Treatment
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* Drug: intermittent boluses of Hypertonic saline
* Drug: continuous infusion of Hypertonic saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who having Isolated traumatized brain injury (not for surgical intervention) 3<GCS ≤ 12. Both genders. Age ≥ 18 and ≤ 60Years. Physical status ASA I - III. Cut off value for optic nerve sheath diameter (ONSD) as 5.5 mm to diagnose increase in ICP> 20 mm Hg. 2. Exclusion criteria Patients' first-degree relatives' refusal to sign the consent. GCS (Glasgow coma score) >12 or GCS of 3. Contraindication to hypertonic saline: pregnancy, coagulopathy and cardiac dysfunction. Spinal cord injury, orbital injury, optic nerve injury and optic neuritis. Multi organ affection. Serum Na level ≥ 150 mmol/L at admission to ICU. Hypotension requiring vasopressors to maintain MAP above 60 mmHg.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hypertonic saline continuous infusion Group<br>will receive Hypertonic saline continuous infusion | Drug: continuous infusion of Hypertonic saline<br>* continuous infusion over a period of 48 hours<br>|
| Active Comparator: Hypertonic saline intermittent boluses Group<br>will receive Hypertonic saline intermittent boluses for 48 hours | Drug: intermittent boluses of Hypertonic saline<br>* intermittent boluses every 6 hours over 30 min for 48 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diameter of Optic nerve sheath | assessment tool for Intracranial pressure | UP TO 48 HOURS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intracranial pressure | Rebound increase intracranial pressure | up to 72 hours | 
| level of Conscious | Glasgow Coma Score : A person's GCS score can range from 3 (completely unresponsive) to 15 (responsive). | UP TO 30 DAY |