Optic Nerve Ultrasound in Severe Traumatic Injury

• Register: ClinicalTrials.gov
• Last refreshed on: 18 January 2021
• Main ID: NCT02618226
• Date of registration: 19/11/2015
• Prospective Registration: Yes
• Primary sponsor: University of Michigan
• Public title: Optic Nerve Ultrasound in Severe Traumatic Injury ONUS-TBI
• Scientific title: 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
• Date of first enrolment: January 2016
• Target sample size: 117
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02618226
• Study type: Observational

Countries of recruitment

India

Contacts

• Name: Venkatakrishna (Krishna) Rajajee, MD
• Affiliation: University of Michigan

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Adult (age>18 years) patients

2. Severe TBI (GCS<8)

3. First measurement feasible <48 hours from time of injury

4. Clinical decision has been made to place an invasive ICP monitor, based on the
recommendations of the Brain Trauma Foundation.

I. GCS<8 and Abnormal CT brain OR II. GCS<8 and Normal CT brain PLUS any 2 of the following

1. Age>40

2. Systolic blood pressure<90

3. Unilateral or Bilateral Posturing

Exclusion Criteria:

1. Patient not expected to survive >48 hours from the time of enrollment

2. Known injury to the globe of the eye or the optic nerve

3. Therapeutic Intensity Level 3 or 4 attained before ONSD measurement can be performed.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Intracranial Hypertension

Traumatic Brain Injury

Intervention(s)

Device: Optic nerve ultrasound

Primary Outcome(s)

Intracranial Pressure (ICP) >25mmHg [Time Frame: Days 1-7]

Secondary Outcome(s)

Poor functional outcome at discharge- Glasgow Outcome Scale <4 [Time Frame: At Discharge from inpatient admission- Average expected to be about 30 days]

Therapeutic Intensity Level (TIL) [Time Frame: Assessed at time of discharge from the neurotrauma intensive care unit- Average expected to be about 7 days]

In-Hospital Mortality [Time Frame: At Discharge from inpatient admission- Average expected to be about 30 days]

Secondary ID(s)

IEC/NP-407/14.11.2014, RP

R03EB019352

HUM00092614

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

All India Institute of Medical Sciences, New Delhi

National Institutes of Health (NIH)