NCT03115450

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
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2018-04-01
• Primary completion: 2018-06-15
• Completion: 2018-06-15
• First posted: 2017-04-14
• Last updated: 2021-10-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study