Traumatic Brain InjuryNCT02786706
Automated Measurement of Optic Nerve Sheath Diameter
An observational study of Traumatic Brain Injury and Acute Brain Injuries, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Acute Brain Injuries, Intracranial Hypertension
- What is being tested?
- Optic nerve ultrasound
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute brain injury requiring invasive ICP monitoring
Who may be able to join
- 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.
Who cannot join
- Pre-existing ocular pathology other than refractive error
- Traumatic globe injury
- Age < 18 years
- Known pregnancy or subsequently discovered pregnancy after admission Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
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
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.
- Being tested
- Optic nerve ultrasound
- Keywords
- Traumatic Brain Injury, Intracranial Pressure, Ultrasonography, Computer-Assisted Image Analysis, Intracranial Hypertension, Acute brain injuries
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic nerve ultrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Optic nerve ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startJul 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Don Massey Foundation
- Responsible party
- Principal investigator, Venkatakrishna Rajajee, University of Michigan
- Investigators
- Venkatakrishna (Krishna) Rajajee, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786706
- Sponsor's protocol ID
- HUM00098976
- Status last verified
- Dec 2020
- First submitted
- 26 May 2016
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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 10616075Farahvar 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 22900846Hansen 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 9202262Rajajee 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 21769456Geeraerts 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 17668184Moretti 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 19098619Copetti 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02786706
- Acronym / sponsor ID
- HUM00098976
- Keywords
- Traumatic Brain Injury, Intracranial Pressure, Ultrasonography, Computer-Assisted Image Analysis, Intracranial Hypertension, Acute brain injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Don Massey Foundation
- Study start
- Jul 2015
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optic nerve ultrasound | – | Device: Optic nerve ultrasoundAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute brain injury requiring invasive ICP monitoring
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Pre-existing ocular pathology other than refractive error
- Traumatic globe injury
- Age < 18 years
- Known pregnancy or subsequently discovered pregnancy after admission Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optic nerve ultrasoundAll 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 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Background: PubMed 10616075Juul 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.
- Background: PubMed 22900846Farahvar 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.
- Background: PubMed 9202262Hansen 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.
- Background: PubMed 21769456Rajajee 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.
- Background: PubMed 17668184Geeraerts 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.
- Background: PubMed 19098619Moretti 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.
- Background: PubMed 19367390Copetti 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venkatakrishna (Krishna) Rajajee, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Acute Brain Injuries, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expert measurement of Optic Nerve Sheath Diameter (time frame: Day of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02786706, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.