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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115450
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Ronak Raval, Loma Linda University

Brief 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.

Condition or disease Intervention/treatment
Intracranial Hemorrhages Brain Injuries Subarachnoid Hemorrhage Ischemic Stroke Stroke Device: Ultrasound Device: Pupilometer

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparative Analysis of Pupilometer and Ultrasound Assessment of Optic Nerve Sheath Diameter in Estimating Intracranial Pressure (ICP)
Actual Study Start Date : May 11, 2017
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Device: Ultrasound
    Type of imaging technology to look at organs and structures inside the body
  • Device: Pupilometer
    A device that measures pupil size and how it changes.


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults that have intracranial pathology requiring either EVD or bolt placement for measuring ICP.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115450


Contacts
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Contact: Ronak Raval, MD 9095584000 ext 48494 rraval@llu.edu
Contact: Amishi Jobanputra, MS 9095585966 ext 55966 ajobanputra@llu.edu

Locations
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United States, California
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Amishi Jobanputra, MS    909-558-4000 ext 55966    ajobanputra@llu.edu   
Sponsors and Collaborators
Loma Linda University
Publications:

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Responsible Party: Ronak Raval, Assistant Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT03115450    
Other Study ID Numbers: 5170065
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019

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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
Keywords provided by Ronak Raval, Loma Linda University:
External ventricular drain (EVD)
Placement of Bolt
Additional relevant MeSH terms:
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Stroke
Brain Injuries
Subarachnoid Hemorrhage
Intracranial Hemorrhages
Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes