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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03115450

Acronym

CUSPICP

Enrollment

Registered

2017-04-14

Start date

2018-04-01

Completion date

2018-06-15

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

External ventricular drain (EVD), Placement of Bolt

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.

Interventions

DEVICEUltrasound

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

DEVICEPupilometer

A device that measures pupil size and how it changes.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Measurement of Optic Nerve Sheath Diameter (ONSD) and corresponding intracranial pressure (ICP).	1 day of ONSD examination	Analysis of varying ONSD and pupillometer readings to concurrent ICP

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026