CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
Ultrasound +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03115450
NCT03115450N/ACompleted

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

Loma Linda University·observational·Posted Apr 14, 2017·Updated Oct 26, 2021

In Brief

An observational study evaluating Ultrasound and Pupilometer for Intracranial Hemorrhages and 4 related conditions. Completed, enrolled 51 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 14, 2017
Enrollment StartApr 1, 2018
Primary CompletionJun 15, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.2 years ago

Interventions

Ultrasounddevice

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

Pupilometerdevice

A device that measures pupil size and how it changes.