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

Stroke Clinical Trial

— CUSPICP  

Official title:

Comparative Analysis of Pupilometer and Ultrasound Assessment of Optic Nerve Sheath Diameter in Estimating Intracranial Pressure (ICP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115450
• Other study ID #: 5170065
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: June 15, 2018

Study information

• Verified date: October 2021
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Ultrasound
Type of imaging technology to look at organs and structures inside the body
• Pupilometer
A device that measures pupil size and how it changes.

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurement of Pupillometer reading and corresponding intracranial pressure (ICP).	Comparison of Neurological Pupil index (NPi) in both eye and concurrent ICP	1 day per nursing protocol (standard of care)