CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 117 enrolled
Drug / intervention
Optic nerve ultrasounddevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02618226
NCT02618226N/ACompleted
CompareCT.gov

Diagnostic Accuracy of Optic Nerve Ultrasound for the Detection of Intracranial Hypertension and Prediction of Therapeutic Intensity Level and Mortality Following Severe Traumatic Brain Injury (ONUS-TBI): a Prospective Blinded Study

University of Michigan·observational·Posted Dec 1, 2015·Updated Jan 5, 2021

In Brief

An observational study evaluating Optic nerve ultrasound for Traumatic Brain Injury and Intracranial Hypertension. Completed, enrolled 117 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsTraumatic Brain Injury, Intracranial Hypertension
CountriesIndia
CollaboratorsAll India Institute of Medical Sciences, National Institutes of Health (NIH), National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 1, 2015
Enrollment StartJan 1, 2016
Primary CompletionDec 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 10.6 years ago

Interventions

Optic nerve ultrasounddevice

Measurement of ONSD with concomitant invasive ICP measurement will be performed at enrollment and at least daily for a total of 7 days. Additional measurements of ONSD may be performed at any time following any decline in Glasgow Coma Scale (GCS) score by 2+ points during the 7 day period.