Intracranial HemorrhagesCUSPICPNCT03115450
Comparison of Pupilometer and Ultrasound of Optic Nerve Sheath Diameter in Estimating Intracranial Pressure (ICP)
An observational study of Intracranial Hemorrhages and Brain Injuries, run by Loma Linda University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hemorrhages, Brain Injuries, Subarachnoid Hemorrhage
- What is being tested?
- Ultrasound and Pupilometer
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 15 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults that have intracranial pathology requiring either EVD or bolt placement for measuring ICP.
Who may be able to join
- Age greater than or equal to 18 years old
- Intracranial pathology requiring either EVD or bolt placement for ICP measurement
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
Official title: 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.
- Conditions
- Intracranial Hemorrhages, Brain Injuries, Subarachnoid Hemorrhage, Ischemic Stroke, Stroke
- Being tested
- Ultrasound, Pupilometer
- Keywords
- External ventricular drain (EVD), Placement of Bolt
- Medical subject headings
- Intracranial Hemorrhages, Brain Injuries, Subarachnoid Hemorrhage, Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Optic Nerve Sheath Diameter (ONSD) and corresponding intracranial pressure (ICP).
Analysis of varying ONSD and pupillometer readings to concurrent ICP
Measured: 1 day of ONSD examination
Secondary outcomes (1)
Measurement of Pupillometer reading and corresponding intracranial pressure (ICP).
Comparison of Neurological Pupil index (NPi) in both eye and concurrent ICP
Measured: 1 day per nursing protocol (standard of care)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start1 Apr 2018
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Intracranial HemorrhagesStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronak Raval, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115450
- Sponsor's protocol ID
- 5170065
- Acronym
- CUSPICP
- Status last verified
- Oct 2021
- First submitted
- 27 Mar 2017
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Chen JW, Gombart ZJ, Rogers S, Gardiner SK, Cecil S, Bullock RM. Pupillary reactivity as an early indicator of increased intracranial pressure: The introduction of the Neurological Pupil index. Surg Neurol Int. 2011;2:82. doi: 10.4103/2152-7806.82248. Epub 2011 Jun 21.
PubMed 21748035Park JG, Moon CT, Park DS, Song SW. Clinical Utility of an Automated Pupillometer in Patients with Acute Brain Lesion. J Korean Neurosurg Soc. 2015 Oct;58(4):363-7. doi: 10.3340/jkns.2015.58.4.363. Epub 2015 Oct 30.
PubMed 26587191Taylor WR, Chen JW, Meltzer H, Gennarelli TA, Kelbch C, Knowlton S, Richardson J, Lutch MJ, Farin A, Hults KN, Marshall LF. Quantitative pupillometry, a new technology: normative data and preliminary observations in patients with acute head injury. Technical note. J Neurosurg. 2003 Jan;98(1):205-13. doi: 10.3171/jns.2003.98.1.0205.
PubMed 12546375Fountas KN, Kapsalaki EZ, Machinis TG, Boev AN, Robinson JS, Troup EC. Clinical implications of quantitative infrared pupillometry in neurosurgical patients. Neurocrit Care. 2006;5(1):55-60. doi: 10.1385/NCC:5:1:55.
PubMed 16960298Meeker M, Du R, Bacchetti P, Privitera CM, Larson MD, Holland MC, Manley G. Pupil examination: validity and clinical utility of an automated pupillometer. J Neurosci Nurs. 2005 Feb;37(1):34-40.
PubMed 15794443Shirodkar CG, Munta K, Rao SM, Mahesh MU. Correlation of measurement of optic nerve sheath diameter using ultrasound with magnetic resonance imaging. Indian J Crit Care Med. 2015 Aug;19(8):466-70. doi: 10.4103/0972-5229.162465.
PubMed 26321806Wroblewski JT, Fadda E, Mazzetta J, Lazarewicz JW, Costa E. Glycine and D-serine act as positive modulators of signal transduction at N-methyl-D-aspartate sensitive glutamate receptors in cultured cerebellar granule cells. Neuropharmacology. 1989 May;28(5):447-52. doi: 10.1016/0028-3908(89)90077-4.
PubMed 2542835Kimberly HH, Shah S, Marill K, Noble V. Correlation of optic nerve sheath diameter with direct measurement of intracranial pressure. Acad Emerg Med. 2008 Feb;15(2):201-4. doi: 10.1111/j.1553-2712.2007.00031.x.
PubMed 18275454
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Pupilometer and Ultrasound Assessment of Optic Nerve Sheath Diameter in Estimating Intracranial Pressure (ICP)
- ClinicalTrials.gov ID
- NCT03115450
- Acronym / sponsor ID
- CUSPICP / 5170065
- Conditions
- Intracranial Hemorrhages, Brain Injuries, Subarachnoid Hemorrhage, Ischemic Stroke, Stroke
- Keywords
- External ventricular drain (EVD), Placement of Bolt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults that have intracranial pathology requiring either EVD or bolt placement for measuring ICP.
Key inclusion criteria (2 listed)
- Age greater than or equal to 18 years old
- Intracranial pathology requiring either EVD or bolt placement for ICP measurement
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundType of imaging technology to look at organs and structures inside the body | Device | – |
| PupilometerA device that measures pupil size and how it changes. | Device | – |
Primary outcome
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 secondary outcome
Measurement of Pupillometer reading and corresponding intracranial pressure (ICP).
Time frame: 1 day per nursing protocol (standard of care)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Background: PubMed 21748035Chen JW, Gombart ZJ, Rogers S, Gardiner SK, Cecil S, Bullock RM. Pupillary reactivity as an early indicator of increased intracranial pressure: The introduction of the Neurological Pupil index. Surg Neurol Int. 2011;2:82. doi: 10.4103/2152-7806.82248. Epub 2011 Jun 21.
- Background: PubMed 26587191Park JG, Moon CT, Park DS, Song SW. Clinical Utility of an Automated Pupillometer in Patients with Acute Brain Lesion. J Korean Neurosurg Soc. 2015 Oct;58(4):363-7. doi: 10.3340/jkns.2015.58.4.363. Epub 2015 Oct 30.
- Background: PubMed 12546375Taylor WR, Chen JW, Meltzer H, Gennarelli TA, Kelbch C, Knowlton S, Richardson J, Lutch MJ, Farin A, Hults KN, Marshall LF. Quantitative pupillometry, a new technology: normative data and preliminary observations in patients with acute head injury. Technical note. J Neurosurg. 2003 Jan;98(1):205-13. doi: 10.3171/jns.2003.98.1.0205.
- Background: PubMed 16960298Fountas KN, Kapsalaki EZ, Machinis TG, Boev AN, Robinson JS, Troup EC. Clinical implications of quantitative infrared pupillometry in neurosurgical patients. Neurocrit Care. 2006;5(1):55-60. doi: 10.1385/NCC:5:1:55.
- Background: PubMed 15794443Meeker M, Du R, Bacchetti P, Privitera CM, Larson MD, Holland MC, Manley G. Pupil examination: validity and clinical utility of an automated pupillometer. J Neurosci Nurs. 2005 Feb;37(1):34-40.
- Background: PubMed 26321806Shirodkar CG, Munta K, Rao SM, Mahesh MU. Correlation of measurement of optic nerve sheath diameter using ultrasound with magnetic resonance imaging. Indian J Crit Care Med. 2015 Aug;19(8):466-70. doi: 10.4103/0972-5229.162465.
- Background: PubMed 2542835Wroblewski JT, Fadda E, Mazzetta J, Lazarewicz JW, Costa E. Glycine and D-serine act as positive modulators of signal transduction at N-methyl-D-aspartate sensitive glutamate receptors in cultured cerebellar granule cells. Neuropharmacology. 1989 May;28(5):447-52. doi: 10.1016/0028-3908(89)90077-4.
- Background: PubMed 18275454Kimberly HH, Shah S, Marill K, Noble V. Correlation of optic nerve sheath diameter with direct measurement of intracranial pressure. Acad Emerg Med. 2008 Feb;15(2):201-4. doi: 10.1111/j.1553-2712.2007.00031.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hemorrhages and Brain Injuries, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Optic Nerve Sheath Diameter (ONSD) and corresponding intracranial pressure (ICP). (time frame: 1 day of ONSD examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03115450, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.