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OpenTrials
Completed

NCT Number: NCT04686344

Point of Care Optic Nerve Sheath Ultrasound to Assess Intracranial Pressure

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".

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Cairo university, Cairo, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who having Isolated traumatized brain injury (not for surgical intervention)
  • 3<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.
  • Exclusion criteria
  • 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.

Treatment and study plan

intermittent boluses of Hypertonic saline

Drug

intermittent boluses every 6 hours over 30 min for 48 hours

continuous infusion of Hypertonic saline

Drug

continuous infusion over a period of 48 hours

Primary outcomes

  1. Diameter of Optic nerve sheath

    Time frame: UP TO 48 HOURS

    assessment tool for Intracranial pressure

Secondary outcomes

  1. intracranial pressure

    Time frame: up to 72 hours

    Rebound increase intracranial pressure

  2. level of Conscious

    Time frame: UP TO 30 DAY

    Glasgow Coma Score : A person's GCS score can range from 3 (completely unresponsive) to 15 (responsive).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 28, 2020
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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