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

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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

Tracking Information
First Submitted Date March 27, 2017
First Posted Date April 14, 2017
Last Update Posted Date October 30, 2019
Actual Study Start Date May 11, 2017
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 13, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 13, 2017)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Pupilometer and Ultrasound of Optic Nerve Sheath Diameter in Estimating Intracranial Pressure (ICP)
Official Title Comparative Analysis of Pupilometer and Ultrasound Assessment of Optic Nerve Sheath Diameter in Estimating Intracranial Pressure (ICP)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults that have intracranial pathology requiring either EVD or bolt placement for measuring ICP.
Condition
  • Intracranial Hemorrhages
  • Brain Injuries
  • Subarachnoid Hemorrhage
  • Ischemic Stroke
  • Stroke
Intervention
  • 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.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 21, 2019)
100
Original Estimated Enrollment
 (submitted: April 13, 2017)
50
Estimated Study Completion Date May 15, 2020
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ronak Raval, MD 9095584000 ext 48494 rraval@llu.edu
Contact: Amishi Jobanputra, MS 9095585966 ext 55966 ajobanputra@llu.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03115450
Other Study ID Numbers 5170065
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Ronak Raval, Loma Linda University
Study Sponsor Loma Linda University
Collaborators Not Provided
Investigators Not Provided
PRS Account Loma Linda University
Verification Date October 2019