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Completed

NCT Number: NCT03115450

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

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.

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Key information

Conditions

Intracranial Hemorrhages Brain Diseases Brain Injuries Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Subarachnoid Hemorrhage Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

Device

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

Pupilometer

Device

A device that measures pupil size and how it changes.

Primary outcomes

  1. Measurement of Optic Nerve Sheath Diameter (ONSD) and corresponding intracranial pressure (ICP).

    Time frame: 1 day of ONSD examination

    Analysis of varying ONSD and pupillometer readings to concurrent ICP

Secondary outcomes

  1. Measurement of Pupillometer reading and corresponding intracranial pressure (ICP).

    Time frame: 1 day per nursing protocol (standard of care)

    Comparison of Neurological Pupil index (NPi) in both eye and concurrent ICP

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Acronym: CUSPICP

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 14, 2017
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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