Clinical trial NCT04686344: Point of Care Optic Nerve Sheath Ultrasound to Assess Intracranial Pressure
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Optic Nerve Sheath
Hypertonic Saline
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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".


Eligibility criteria: Inclusion Criteria:

1. Patients who having Isolated traumatized brain injury (not for surgical intervention)
2. 3\<GCS ≤ 12.
3. Both genders.
4. Age ≥ 18 and ≤ 60Years.
5. Physical status ASA I - III.
6. Cut off value for optic nerve sheath diameter (ONSD) as 5.5 mm to diagnose increase in ICP\> 20 mm Hg.

2. Exclusion criteria

1. Patients' first-degree relatives' refusal to sign the consent.
2. GCS (Glasgow coma score) \>12 or GCS of 3.
3. Contraindication to hypertonic saline: pregnancy, coagulopathy and cardiac dysfunction.
4. Spinal cord injury, orbital injury, optic nerve injury and optic neuritis.
5. Multi organ affection.
6. Serum Na level ≥ 150 mmol/L at admission to ICU.
7. Hypotension requiring vasopressors to maintain MAP above 60 mmHg.

Primary outcomes:
measure: Diameter of Optic nerve sheath
timeFrame: UP TO 48 HOURS
Secondary outcomes:
measure: intracranial pressure
timeFrame: up to 72 hours
measure: level of Conscious
timeFrame: UP TO 30 DAY
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University.
Study officials:
References: