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

Sponsor

Loma Linda University (Other)

Overall Status

Completed

CT.gov ID

NCT03115450

Collaborator

(none)

Enrollment

Location

2.5

Actual Duration (Months)

20.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Hemorrhages Brain Injuries Subarachnoid Hemorrhage Ischemic Stroke Stroke	Device: Ultrasound Device: Pupilometer

Study Design

Study Type:

Observational

Actual Enrollment :

51 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2018

Actual Primary Completion Date :

Jun 15, 2018

Actual Study Completion Date :

Jun 15, 2018

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.