Point of Care Optic Nerve Sheath Ultrasound to Assess Intracranial Pressure

Hypertonic Saline Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04686344
• Other study ID #: MS-383-2020
• Status: Completed
• Phase: Early Phase 1
• Start date: December 21, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: September 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 30, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertonic Saline
• Optic Nerve Sheath

Intervention

Drug:
• intermittent boluses of Hypertonic saline
intermittent boluses every 6 hours over 30 min for 48 hours
• continuous infusion of Hypertonic saline
continuous infusion over a period of 48 hours

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo
Egypt	Faculty of Medicine, Cairo University.	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diameter of Optic nerve sheath	assessment tool for Intracranial pressure	UP TO 48 HOURS
Secondary	intracranial pressure	Rebound increase intracranial pressure	up to 72 hours
Secondary	level of Conscious	Glasgow Coma Score : A person's GCS score can range from 3 (completely unresponsive) to 15 (responsive).	UP TO 30 DAY