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

October 24, 2021 updated by: Ronak Raval, Loma Linda University

Comparative Analysis of Pupilometer and Ultrasound Assessment 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults that have intracranial pathology requiring either EVD or bolt placement for measuring ICP.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day of ONSD examination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day per nursing protocol (standard of care)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

June 15, 2018

Study Completion (Actual)

June 15, 2018

Study Registration Dates

First Submitted

March 27, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 24, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5170065

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe