Optic Nerve Sheath Diameter as a Screening Test for Increased Intracranial Pressure

NCT02338284 | Unknown

• 1 other identifier: 2141 103
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients admitted to the ICU may have delayed awakening after their critical illness has resolved. Though most either are due to metabolic causes or delayed elimination of sedative medications, more serious pathologies such as intracranial hemorrhage, ischemic stroke, and vasogenic edema may also be the cause of coma. These pathologies all result in increases in intracranial pressure (ICP) with cerebral edema. Identifying elevated intracranial pressure elevations have so far, relied on invasive monitoring techniques requiring placement of an intracranial or intraventricular catheter. The optic nerve sheath diameter (ONSD) has been described as a highly sensitive (88-94%) and specific (85% - 94%) noninvasive technique of identifying increased intracranial pressures in patients with brain trauma, intracranial bleeding or stroke\[1-4\]. This method requires placement of an ultrasound probe on the patient's closed eyelid and then a direct measurement of the diameter of the optic nerve sheath at a pre-specified distance from the globe. A value greater than 58 mm has been shown to correlate significantly with an increased ICP (\> 20 cm H20); r = 0.71, p\<0.001 \[5\]. The investigators hypothesize that bedside ultrasound measurement of the ONSD is a simple screening test for increased intracranial pressure and can be used to rapidly and efficiently identify patients in the ICU who have coma due to an increase in intracranial pressure. The investigators propose to carry out an observational trial to determine the predictive ability of the Optic Nerve Sheath Diameter for cerebral edema/ increased intracranial pressure and to compare it with the results of neuroimaging (CT and/or MRI).

Conditions

Coma

Keywords

increased intracranial pressure; optic nerve sheath diameter

Outcome Measures

Primary Outcomes (1)

• Diagnosis of Cerebral edema by Optic nerve sheath diameter

  24 hours

Interventions

ultrasound of globe OTHER

* A high resolution 7.5 -10 MHz linear array ultrasound transducer probe will be used. A large amount of standard water-soluble ultrasound transmission gel will be applied to the patient's closed eyelid. The globe will be scanned in the transverse plane.• The ONSD will be measured at a predefined point 3 mm posterior to the globe in both eyes. • Measurement of the ONSD for both eyes will be done and the average the two measurements will be taken. * A value \> 58mm (from reference 1) will be considered as indicative of increased ICP and the primary ICU team will be informed for rapid measures to decrease ICP or urgent imaging of the CNS.

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive, adult patients already admitted to the critical care service with unexplained coma

You may qualify if:

• Consecutive, adult patients already admitted to the critical care service and in whom a cause of coma is not determined.

You may not qualify if:

• Obvious ocular trauma
• Patients on sedative or narcotic infusions

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital & Research Centre

Riyadh, Ar-Riyadh, 11211, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Coma; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Study Officials

• nawal salahuddin, MD,FCCP

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa Mohamed, MD

CONTACT

966553730044; dr.alaibrahim@gmail.com

NADIA ALHARBI, MD

CONTACT

966562042098; dr-n.al-harbi@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 14, 2015
• Study Start: October 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 16, 2015

Record last verified: 2015-06

Locations

SA (1)