CompletedNot Applicable

Optic Nerve Ultrasound in Severe Traumatic Injury

India117 participantsStarted 2016-01

Plain-language summary

Prospective study of diagnostic accuracy of optic nerve sheath diameter measurement (index study) in traumatic brain injury with simultaneous invasive intracranial pressure monitoring as the reference standard.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adult (age\>18 years) patients
✓. Severe TBI (GCS\<8)
✓. First measurement feasible \<48 hours from time of injury
✓. Clinical decision has been made to place an invasive ICP monitor, based on the recommendations of the Brain Trauma Foundation.
✓. Age\>40
✓. Systolic blood pressure\<90
✓. Unilateral or Bilateral Posturing

Exclusion criteria

✕. Patient not expected to survive \>48 hours from the time of enrollment
✕. Known injury to the globe of the eye or the optic nerve
✕. Therapeutic Intensity Level 3 or 4 attained before ONSD measurement can be performed.

What they're measuring

Intracranial Pressure (ICP) >25mmHg

Timeframe: Days 1-7

Trial details

NCT IDNCT02618226

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12

View on ClinicalTrials.gov More Traumatic Brain Injury trials