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Automated Measurement of Optic Nerve Sheath Diameter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02786706
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
Don Massey Foundation
Information provided by (Responsible Party):
Venkatakrishna Rajajee, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Acute Brain Injuries Intracranial Hypertension Device: Optic nerve ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Accuracy of Optic Nerve Sheath Diameter Measurement From Ultrasound Videos Using an Image Analysis Algorithm Compared to Expert Measurement in Patients With Acute Brain Injury
Study Start Date : July 2015
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Expert measurement of Optic Nerve Sheath Diameter [ Time Frame: Day of enrollment ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • Pre-existing ocular pathology other than refractive error
  • Traumatic globe injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786706


Locations
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United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Don Massey Foundation
Investigators
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Principal Investigator: Venkatakrishna (Krishna) Rajajee, MD University of Michigan
Additional Information:
Publications:

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Responsible Party: Venkatakrishna Rajajee, Clinical Associate Professor, Neurosurgery and Neurology Medical Director, Neurointensive Care, University of Michigan
ClinicalTrials.gov Identifier: NCT02786706    
Other Study ID Numbers: HUM00098976
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Venkatakrishna Rajajee, University of Michigan:
Traumatic Brain Injury
Intracranial Pressure
Ultrasonography
Computer-Assisted Image Analysis
Intracranial Hypertension
Acute brain injuries
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Intracranial Hypertension
Hypertension
Wounds and Injuries
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System