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

Completed

• Conditions: Brain Injuries; Ischemic Stroke; Subarachnoid Hemorrhage; Stroke; Intracranial Hemorrhages

• Registration Number: NCT03115450
• Lead Sponsor: Loma Linda University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-14
• Study Start: 2018-04-01
• Primary Completion: 2018-06-15
• Study Completion: 2018-06-15
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-24
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States