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

NCT03115450 | Completed DMC FDA Device

• 1 other identifier: 5170065
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracranial Hemorrhages; Brain Injuries; Subarachnoid Hemorrhage; Ischemic Stroke; Stroke

Keywords

External ventricular drain (EVD); Placement of Bolt

Outcome Measures

Primary Outcomes (1)

• Measurement of Optic Nerve Sheath Diameter (ONSD) and corresponding intracranial pressure (ICP).

  Analysis of varying ONSD and pupillometer readings to concurrent ICP

  1 day of ONSD examination

Secondary Outcomes (1)

• Measurement of Pupillometer reading and corresponding intracranial pressure (ICP).

  1 day per nursing protocol (standard of care)

Interventions

Ultrasound DEVICE

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

Pupilometer DEVICE

A device that measures pupil size and how it changes.

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

Adults that have intracranial pathology requiring either EVD or bolt placement for measuring ICP.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Related Publications (8)

• 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.

  PMID: 21748035 BACKGROUND

• 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.

  PMID: 26587191 BACKGROUND

• 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.

  PMID: 12546375 BACKGROUND

• 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.

  PMID: 16960298 BACKGROUND

• 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.

  PMID: 15794443 BACKGROUND

• 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.

  PMID: 26321806 BACKGROUND

• 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.

  PMID: 2542835 BACKGROUND

• 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.

  PMID: 18275454 BACKGROUND

MeSH Terms

Conditions

Intracranial Hemorrhages; Brain Injuries; Subarachnoid Hemorrhage; Ischemic Stroke; Stroke

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 14, 2017
• Study Start: April 1, 2018
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

US (1)