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Comparison of Pupilometer and Ultrasound of Optic Nerve Sheath Diameter in Estimating Intracranial Pressure (ICP)

NCT ID: NCT03115450

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-06-15

Brief Summary

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The purpose of this investigator-initiated study is to compare the use of pupilometer and ultrasound assessment of optic nerve sheath diameter in predicting the ICP and to see if there is a value that could be used to indicate elevated ICP with either modality as these numbers are inconsistent throughout the literature. Patients that have either an external ventricular drain (EVD) or bolt placed will be enrolled in the study. After the EVD and bolt are placed the patient will undergo pupilometer examination (standard of care) followed by ultrasound assessment of the optic nerve sheath diameter (ONSD). The three values will be recorded. The same patient may have multiple readings performed if there is a change in ICP either spontaneously or due to intervention.

Detailed Description

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Conditions

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Intracranial Hemorrhages Brain Injuries Subarachnoid Hemorrhage Ischemic Stroke Stroke

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Ultrasound

Type of imaging technology to look at organs and structures inside the body

Intervention Type DEVICE

Pupilometer

A device that measures pupil size and how it changes.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age greater than or equal to 18 years old
* Intracranial pathology requiring either EVD or bolt placement for ICP measurement

Exclusion Criteria

* Known disorder of lens or orbit including but not limited to glaucoma, cataract, blindness, lens implants.
* Patients unable to close eyelids as this would increase risk of corneal abrasion from ultrasound probe.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Ronak Raval

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Countries

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United States

References

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Chen JW, Gombart ZJ, Rogers S, Gardiner SK, Cecil S, Bullock RM. Pupillary reactivity as an early indicator of increased intracranial pressure: The introduction of the Neurological Pupil index. Surg Neurol Int. 2011;2:82. doi: 10.4103/2152-7806.82248. Epub 2011 Jun 21.

Reference Type BACKGROUND
PMID: 21748035 (View on PubMed)

Park JG, Moon CT, Park DS, Song SW. Clinical Utility of an Automated Pupillometer in Patients with Acute Brain Lesion. J Korean Neurosurg Soc. 2015 Oct;58(4):363-7. doi: 10.3340/jkns.2015.58.4.363. Epub 2015 Oct 30.

Reference Type BACKGROUND
PMID: 26587191 (View on PubMed)

Taylor WR, Chen JW, Meltzer H, Gennarelli TA, Kelbch C, Knowlton S, Richardson J, Lutch MJ, Farin A, Hults KN, Marshall LF. Quantitative pupillometry, a new technology: normative data and preliminary observations in patients with acute head injury. Technical note. J Neurosurg. 2003 Jan;98(1):205-13. doi: 10.3171/jns.2003.98.1.0205.

Reference Type BACKGROUND
PMID: 12546375 (View on PubMed)

Fountas KN, Kapsalaki EZ, Machinis TG, Boev AN, Robinson JS, Troup EC. Clinical implications of quantitative infrared pupillometry in neurosurgical patients. Neurocrit Care. 2006;5(1):55-60. doi: 10.1385/NCC:5:1:55.

Reference Type BACKGROUND
PMID: 16960298 (View on PubMed)

Meeker M, Du R, Bacchetti P, Privitera CM, Larson MD, Holland MC, Manley G. Pupil examination: validity and clinical utility of an automated pupillometer. J Neurosci Nurs. 2005 Feb;37(1):34-40.

Reference Type BACKGROUND
PMID: 15794443 (View on PubMed)

Shirodkar CG, Munta K, Rao SM, Mahesh MU. Correlation of measurement of optic nerve sheath diameter using ultrasound with magnetic resonance imaging. Indian J Crit Care Med. 2015 Aug;19(8):466-70. doi: 10.4103/0972-5229.162465.

Reference Type BACKGROUND
PMID: 26321806 (View on PubMed)

Wroblewski JT, Fadda E, Mazzetta J, Lazarewicz JW, Costa E. Glycine and D-serine act as positive modulators of signal transduction at N-methyl-D-aspartate sensitive glutamate receptors in cultured cerebellar granule cells. Neuropharmacology. 1989 May;28(5):447-52. doi: 10.1016/0028-3908(89)90077-4.

Reference Type BACKGROUND
PMID: 2542835 (View on PubMed)

Kimberly HH, Shah S, Marill K, Noble V. Correlation of optic nerve sheath diameter with direct measurement of intracranial pressure. Acad Emerg Med. 2008 Feb;15(2):201-4. doi: 10.1111/j.1553-2712.2007.00031.x.

Reference Type BACKGROUND
PMID: 18275454 (View on PubMed)

Other Identifiers

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5170065

Identifier Type: -

Identifier Source: org_study_id