Point of Care Optic Nerve Sheath Ultrasound to Assess Intracranial Pressure

Cairo University (CU)

Status and phase: Completed; Early Phase 1

Conditions: Hypertonic Saline; Optic Nerve Sheath

Treatments: Drug: continuous infusion of Hypertonic saline; Drug: intermittent boluses of Hypertonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04686344

MS-383-2020

Details and patient eligibility

About

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".

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

7. Exclusion criteria

8. Patients' first-degree relatives' refusal to sign the consent.

9. GCS (Glasgow coma score) >12 or GCS of 3.

10. Contraindication to hypertonic saline: pregnancy, coagulopathy and cardiac dysfunction.

11. Spinal cord injury, orbital injury, optic nerve injury and optic neuritis.

12. Multi organ affection.

13. Serum Na level ≥ 150 mmol/L at admission to ICU.

14. Hypotension requiring vasopressors to maintain MAP above 60 mmHg.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Hypertonic saline continuous infusion Group

Active Comparator group

Description:

will receive Hypertonic saline continuous infusion

Treatment:

Drug: continuous infusion of Hypertonic saline

Hypertonic saline intermittent boluses Group

Active Comparator group

Description:

will receive Hypertonic saline intermittent boluses for 48 hours

Treatment:

Drug: intermittent boluses of Hypertonic saline