Point of Care Optic Nerve Sheath Ultrasound to Assess Intracranial Pressure

NCT04686344 | Completed Early Phase 1 DMC

• 1 other identifier: MS-383-2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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".

Conditions

Optic Nerve Sheath; Hypertonic Saline

Outcome Measures

Primary Outcomes (1)

• Diameter of Optic nerve sheath

  assessment tool for Intracranial pressure

  UP TO 48 HOURS

Secondary Outcomes (2)

• intracranial pressure

  up to 72 hours

• level of Conscious

  UP TO 30 DAY

Study Arms (2)

Hypertonic saline continuous infusion Group

ACTIVE COMPARATOR

will receive Hypertonic saline continuous infusion

Drug: continuous infusion of Hypertonic saline

Hypertonic saline intermittent boluses Group

ACTIVE COMPARATOR

will receive Hypertonic saline intermittent boluses for 48 hours

Drug: intermittent boluses of Hypertonic saline

Interventions

intermittent boluses of Hypertonic saline DRUG

intermittent boluses every 6 hours over 30 min for 48 hours

Hypertonic saline intermittent boluses Group

continuous infusion of Hypertonic saline DRUG

continuous infusion over a period of 48 hours

Hypertonic saline continuous infusion Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Cairo university

Cairo, 11451, Egypt

Location

Faculty of Medicine, Cairo University.

Cairo, 11451, Egypt

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Pain management and Surgical ICU

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 28, 2020
• Study Start: December 21, 2020
• Primary Completion: August 10, 2021
• Study Completion: August 30, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

EG (2)