Point of Care Optic Nerve Sheath Ultrasound to Assess Intracranial Pressure

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.

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".

Study Overview

• Status: Completed
• Conditions: Optic Nerve Sheath; Hypertonic Saline
• Intervention / Treatment: Drug: continuous infusion of Hypertonic saline; Drug: intermittent boluses of Hypertonic saline

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Faculty of medicine, Cairo University.
  • Cairo, Egypt, 11451
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Hypertonic saline continuous infusion Group; will receive Hypertonic saline continuous infusion	Drug: continuous infusion of Hypertonic saline; continuous infusion over a period of 48 hours
ACTIVE_COMPARATOR: Hypertonic saline intermittent boluses Group; will receive Hypertonic saline intermittent boluses for 48 hours	Drug: intermittent boluses of Hypertonic saline; intermittent boluses every 6 hours over 30 min for 48 hours

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 21, 2020
• Primary Completion (ACTUAL): August 10, 2021
• Study Completion (ACTUAL): August 30, 2021

Study Registration Dates

• First Submitted: December 19, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (ACTUAL): December 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: MS-383-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No