Coma Clinical Trial
Official title:
Optic Nerve Sheath Diameter Measured by Bedside Ultrasound May be a Simple Screening Test for Increased Intracranial Pressure in the Comatose Critically Ill Patient
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).
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 14 Years and older |
Eligibility |
Inclusion Criteria: - Consecutive, adult patients already admitted to the critical care service and in whom a cause of coma is not determined. Exclusion Criteria: - Obvious ocular trauma - Patients on sedative or narcotic infusions |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | King Faisal Specialist Hospital & Research Centre | Riyadh | Ar-Riyadh |
Lead Sponsor | Collaborator |
---|---|
King Faisal Specialist Hospital & Research Center |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosis of Cerebral edema by Optic nerve sheath diameter | 24 hours | No |
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