Automated Measurement of Optic Nerve Sheath Diameter

NCT02786706 | Completed FDA Device

• 1 other identifier: HUM00098976
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Brain Injury; Acute Brain Injuries; Intracranial Hypertension

Keywords

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

Outcome Measures

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.

  Day of enrollment

Study Arms (1)

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

Optic nerve ultrasound DEVICE

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.

Optic nerve ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute brain injury requiring invasive ICP monitoring

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• Don Massey Foundation: collaborator

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (7)

• 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.

  PMID: 10616075 BACKGROUND

• 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.

  PMID: 22900846 BACKGROUND

• 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.

  PMID: 9202262 BACKGROUND

• 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.

  PMID: 21769456 BACKGROUND

• 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.

  PMID: 17668184 BACKGROUND

• 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.

  PMID: 19098619 BACKGROUND

• 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.

  PMID: 19367390 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Venkatakrishna (Krishna) Rajajee, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Neurosurgery and Neurology Medical Director, Neurointensive Care

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 1, 2016
• Study Start: July 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 4, 2020

Record last verified: 2020-12

Locations

US (1)