Optic Nerve Ultrasound in Severe Traumatic Injury (NCT02618226) | Clinical Trial Compass
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.
1This trial used ultrasound of the optic nerve to detect dangerous pressure in the brain — is this kind of non-invasive measurement something that could be used in my or my family member's care, and how reliable is it compared to standard ICP monitoring methods?
2Since this trial is already completed, have the results been published, and what did they show about how well optic nerve ultrasound predicted intracranial pressure above 25mmHg in traumatic brain injury patients?
3The trial focused on detecting ICP above 25mmHg as the key threshold — can you explain why that number matters clinically, and what treatment decisions would change if pressure reaches that level?
4Because this was a diagnostic study rather than a treatment trial, does it change anything about the actual treatment options available to us, or is it more about improving how doctors monitor the condition?
5Are there situations where optic nerve ultrasound might be especially useful for someone with a severe traumatic brain injury — for example, when standard invasive ICP monitoring isn't possible or carries too much risk?
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.