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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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