CClinicalTrials.gg
CompletedNCT02786706Updated Dec 4, 2020

Automated Measurement of Optic Nerve Sheath Diameter

An observational study in Traumatic Brain Injury, Acute Brain Injuries and Intracranial Hypertension, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-04.

Sponsored by University of Michigan · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
75
Ages
18 Years and older
Sex
All
01

Study summary

Optic Nerve Ultrasound (ONUS) is a promising non-invasive tool for the detection of raised Intracranial Pressure (ICP). Variability in the optimal Optic Nerve Sheath Diameter (ONSD) threshold corresponding to elevated ICP in multiple studies limits the value of ONUS in clinical practice. The investigators goal is to develop and validate an automated image analysis algorithm for standardization of ONSD measurement from ultrasound videos. Patients with acute brain injury requiring invasive ICP monitoring will undergo bedside ONUS, with blinded ONSD measurement by an expert investigator. The image analysis algorithm will then be used to measure ONSD and accuracy determined compared to the "reference standard" expert measurement.

Read the detailed description

BACKGROUND:

A promising tool under investigation for the non-invasive estimation of ICP is Optic Nerve Ultrasound (ONUS). Raised ICP results in distension of the optic nerve sheath (ONS), a continuation of the dura mater. Ocular imaging, performed by clinicians using point-of-care ultrasound machines, can detect ONS distension behind the eye. A study conducted at the University of Michigan identified an ONS Diameter (ONSD) cutoff of >0.51cm as having 98% sensitivity and 91% specificity for the detection of intracranial hypertension, defined as ICP>25mmHg. The significant variation seen in the optimal ONSD threshold for identification of high ICP across several studies, however, greatly limits the practical application of this technique at the bedside. Much of this variation in the optimal ONSD threshold is likely related to technique, with variation in the margins used to define the ONS on acquired ultrasound images by different operators. The ONS, visible as a linear hypodense structure behind the eye can vary in its visualized dimension based on the angle and plane of insonation. Automated image analysis may permit standardization of ONSD measurement and thereby minimize interobserver variability.

SPECIFIC AIM:

The investigators goal is to develop a computer image-analysis algorithm to standardize measurement of the ONSD from ultrasound videos, and to validate against the reference standard of expert manual measurement of ONSD.

METHODS:

Development of image-analysis algorithm: Videos in DICOM format of prior ONUS studies performed for clinical purposes in the neurointensive care unit will be deidentified and used for initial development and modification of the automated image analysis algorithm, prior to prospective enrollment of subjects for determination of accuracy.

Under IRB approval, the investigators will perform Optic Nerve Ultrasound (ONUS) on eligible subjects admitted to the ICU following informed consent of the patient or appropriate surrogate.

Optic Nerve Ultrasound and ONSD measurement: These patients will undergo ONUS in the ICU. ONUS is performed with the patient's eye closed, and with a linear array transducer placed on the upper margin of the orbit to obtain a sonographic video clip of the eye, followed by bedside measurement of ONSD 3mm behind the level of the posterior scleral border. Imaging will be performed for both eyes for each patient. The expert investigator performing the ONUS study and manual ONSD measurement will be blinded to the patient's ICP by turning the monitor away from the sonographer from the time of entry into the patient's room until exit. The corresponding ICP from the invasive monitor will be separately documented by the bedside nurse. The ONUS video corresponding to the highest measured ONSD will be submitted in DICOM format for automated image analysis.

Equipment: Sonosite M-Turbo point-of-care ultrasound machine and an L25 linear array transducer with an ophthalmic preset.

Statistical Analysis:

  • Simple descriptive statistics including means and standard deviations
  • Simple Pearson correlation to allow for visual inspection across a range of values
  • Tukey mean-difference plot (Bland - Altman plot) will be used to assess agreement between the two methods, the ultrasound video analysis of optic nerve sheath diameter and ONSD ultrasound interpretation by a clinician. Limits of agreement will be calculated with standard errors and 95% confidence intervals.
02

Conditions studied

  • Traumatic Brain Injury
  • Acute Brain Injuries
  • Intracranial Hypertension

Keywords

  • Traumatic Brain Injury
  • Intracranial Pressure
  • Ultrasonography
  • Computer-Assisted Image Analysis
  • Intracranial Hypertension
  • Acute brain injuries
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.

This study's enrollment of 75 is below the median of 100 across 689 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with acute brain injury requiring invasive ICP monitoring

Inclusion criteria

  • Admitted to an ICU in the University of Michigan with Acute Brain Injury
  • Age> 18 years
  • Invasive ICP monitor (external ventricular drain or intraparenchymal catheter) already in place for a clinical indication.

Exclusion criteria

Exclusion Criteria:

  • Pre-existing ocular pathology other than refractive error
  • Traumatic globe injury
  • Age \< 18 years
  • Known pregnancy or subsequently discovered pregnancy after admission Prisoners
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
75 participants (actual)
Patient registry
No

Groups and cohorts

  • Optic nerve ultrasound

    All patients will undergo Optic Nerve Ultrasound (ONUS), with measurement of Optic Nerve Sheath Diameter (ONSD) by both an expert investigator as well as by the automated image analysis algorithm.

    Device: Optic nerve ultrasound

Interventions

  • DeviceOptic nerve ultrasound

    All patients will undergo Optic Nerve Ultrasound (ONUS), with measurement of Optic Nerve Sheath Diameter (ONSD) by both an expert investigator as well as by the automated image analysis algorithm.

06

What researchers measure

Primary outcomes

  1. Expert measurement of Optic Nerve Sheath Diameter

    The primary endpoint for determination of accuracy of automated image analysis measurement of Optic Nerve Sheath Diameter (ONSD) will be ONSD measurement performed by an expert investigator with \>5 years experience with ONUS and ONSD measurement.

    Time frame: Day of enrollment

07

Study locations

1 site
  • University of Michigan Health System
    Ann Arbor, Michigan 48109, United States
08

References and documents

Publications

  • Juul N, Morris GF, Marshall SB, Marshall LF. Intracranial hypertension and cerebral perfusion pressure: influence on neurological deterioration and outcome in severe head injury. The Executive Committee of the International Selfotel Trial. J Neurosurg. 2000 Jan;92(1):1-6. doi: 10.3171/jns.2000.92.1.0001. PubMed 10616075 ↗
  • Farahvar A, Gerber LM, Chiu YL, Carney N, Hartl R, Ghajar J. Increased mortality in patients with severe traumatic brain injury treated without intracranial pressure monitoring. J Neurosurg. 2012 Oct;117(4):729-34. doi: 10.3171/2012.7.JNS111816. Epub 2012 Aug 17. PubMed 22900846 ↗
  • Hansen HC, Helmke K. Validation of the optic nerve sheath response to changing cerebrospinal fluid pressure: ultrasound findings during intrathecal infusion tests. J Neurosurg. 1997 Jul;87(1):34-40. doi: 10.3171/jns.1997.87.1.0034. PubMed 9202262 ↗
  • Rajajee V, Vanaman M, Fletcher JJ, Jacobs TL. Optic nerve ultrasound for the detection of raised intracranial pressure. Neurocrit Care. 2011 Dec;15(3):506-15. doi: 10.1007/s12028-011-9606-8. PubMed 21769456 ↗
  • Geeraerts T, Launey Y, Martin L, Pottecher J, Vigue B, Duranteau J, Benhamou D. Ultrasonography of the optic nerve sheath may be useful for detecting raised intracranial pressure after severe brain injury. Intensive Care Med. 2007 Oct;33(10):1704-11. doi: 10.1007/s00134-007-0797-6. Epub 2007 Aug 1. PubMed 17668184 ↗
  • Moretti R, Pizzi B. Optic nerve ultrasound for detection of intracranial hypertension in intracranial hemorrhage patients: confirmation of previous findings in a different patient population. J Neurosurg Anesthesiol. 2009 Jan;21(1):16-20. doi: 10.1097/ANA.0b013e318185996a. PubMed 19098619 ↗
  • Copetti R, Cattarossi L. Optic nerve ultrasound: artifacts and real images. Intensive Care Med. 2009 Aug;35(8):1488-9; author reply 1490-1. doi: 10.1007/s00134-009-1494-4. Epub 2009 Apr 15. No abstract available. PubMed 19367390 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02786706
Lead sponsor
University of Michigan
Collaborators
Don Massey Foundation
Responsible party
Venkatakrishna Rajajee (Clinical Associate Professor, Neurosurgery and Neurology Medical Director, Neurointensive Care, University of Michigan) — Principal investigator
First posted
Jun 1, 2016
Start date
Jul 2015
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Dec 4, 2020

Study contacts

Venkatakrishna (Krishna) Rajajee, MD
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion