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NCT03115450 · ClinicalTrials.gov registry record
Comparison of Pupilometer and Ultrasound of Optic Nerve Sheath Diameter in Estimating Intracranial Pressure (ICP)
A clinical trial, sponsored by Loma Linda University.
- Completed
- Registry status
- 51
- Enrollment target
NCT03115450: Completed study, sponsored by Loma Linda University.
NCT03115450 is a clinical trial that has completed, run by Loma Linda University. The registered enrollment target is 51 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03115450 has completed, sponsored by Loma Linda University.
- COMPLETED
- Registry status
- 51 participants
- Enrollment target
Study 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.
Primary Outcome
Analysis of varying ONSD and pupillometer readings to concurrent ICP
Interventions
- DEVICE Ultrasound
- DEVICE Pupilometer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2018-04-01 |
| Est. Completion | 2018-06-15 |
What the finished NCT03115450 record still lists
NCT03115450 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 51 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Ultrasound is the first listed.
NCT03115450 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03115450 about?
NCT03115450 is a clinical study titled "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 throu...
What is the current status of trial NCT03115450?
This trial is currently completed. The enrollment target is 51 participants. The study started on 2018-04-01. Estimated completion is 2018-06-15.
What interventions are being tested in trial NCT03115450?
The interventions under investigation include: Ultrasound (DEVICE), Pupilometer (DEVICE).
Who is sponsoring clinical trial NCT03115450?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
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