NCT03865576

Brief Summary

For purposes of validation, this study compares intracranial pressure measurements obtained with a novel self-calibrating, non-invasive, intracranial pressure measuring (ICP) device, with the values obtained from (a) patients in an intensive care unit (ICU) whose meet standard clinical indications for ICP measurement and whose ICP is measured using gold-standard implanted intracranial instrumentation and in (b) ambulatory subjects who meet clinical indications for lumbar puncture.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

8 months

First QC Date

February 28, 2019

Last Update Submit

March 5, 2019

Conditions

Intracranial HypertensionAbnormality of Intracranial Pressure

Keywords

ICPPapilledemaNeurological Intensive Care

Outcome Measures

Primary Outcomes (2)

  • Non-invasive intracranial pressure (ICP) value

    ICP value measured using novel non-invasive measurement device

    Up to 5 days after admission to ICU

  • Second non-invasive intracranial pressure (ICP) value

    A second measurement of ICP using novel non-invasive ICP measurement device

    Up to 6 days after admission to ICU

Study Arms (4)

Thomas Jefferson University

Patients in intensive care with altered intracranial pressure. Intervention: Non-invasive ICP measurement using transorbital Doppler ultrasound device. Comparison of measurements obtained with values derived from surgically implanted ICP monitoring sensors.

Diagnostic Test: Non-invasive ICP measurement

Honor Health in Phoenix

Patients in intensive care with altered intracranial pressure. Intervention: Non-invasive ICP measurement using transorbital Doppler ultrasound device. Comparison of measurements obtained with values derived from surgically implanted ICP monitoring sensors.

Diagnostic Test: Non-invasive ICP measurement

Emory University Hospital in Atlanta

Patients in intensive care with altered intracranial pressure. Intervention: Non-invasive ICP measurement using transorbital Doppler ultrasound device. Comparison of measurements obtained with values derived from surgically implanted ICP monitoring sensors

Diagnostic Test: Non-invasive ICP measurement

University of Washington

Patients in intensive care with altered intracranial pressure. Intervention: Non-invasive ICP measurement using transorbital Doppler ultrasound device. . Comparison of measurements obtained with values derived from surgically implanted ICP monitoring sensors and lumbar puncture

Diagnostic Test: Non-invasive ICP measurement

Interventions

Non-invasive ICP measurementDIAGNOSTIC_TEST

Intracranial pressure will be measured non-invasively using transorbital Doppler ultrasound. Values will be compared to ICP measured by lumbar puncture or implanted ICP sensors

Emory University Hospital in AtlantaHonor Health in PhoenixThomas Jefferson UniversityUniversity of Washington

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in an ICU who meet clinical criteria for invasive ICP measurement,

You may qualify if:

  • ICU patients suspected of having an abnormality of ICP undergoing monitoring with commercially-available, FDA-approved instrumentation.

You may not qualify if:

  • History of:
  • Glaucoma or optic hypertension
  • Severe orbital or ophthalmic injury
  • Orbital or intraocular surgery that might interfere with orbital compliance
  • Congenital malformations of the eye and/or orbit that might interfere with orbital compliance or orbital vascular anatomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Honor Health Research Institute

Phoenix, Arizona, 85258, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Thomas Jefferson Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Intracranial HypertensionPapilledema

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesOptic Nerve DiseasesCranial Nerve DiseasesEye Diseases

Study Officials

  • T Forcht Dagi, MD, DMedSc

    Boston Neurosciences

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2019

First Posted

March 7, 2019

Study Start

March 1, 2019

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

March 7, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(4)