Point of Care Optic Nerve Sheath Ultrasound to Assess Intracranial Pressure

Early Phase 1

Completed

• Conditions: Optic Nerve Sheath; Hypertonic Saline
• Interventions: Drug: continuous infusion of Hypertonic saline; Drug: intermittent boluses of Hypertonic saline

• Registration Number: NCT04686344
• Lead Sponsor: Cairo University

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".

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-19
• Study Start: 2020-12-21
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-28
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypertonic saline continuous infusion Group	continuous infusion of Hypertonic saline	will receive Hypertonic saline continuous infusion
Hypertonic saline intermittent boluses Group	intermittent boluses of Hypertonic saline	will receive Hypertonic saline intermittent boluses for 48 hours

Primary Outcome Measures

Name	Time	Method
Diameter of Optic nerve sheath	UP TO 48 HOURS	assessment tool for Intracranial pressure

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Cairo university; 🇪🇬 Cairo, Egypt

Faculty of Medicine, Cairo University.; 🇪🇬 Cairo, Egypt