UnknownNot Applicable

Validation of Non-Invasive Intracranial Pressure (ICP) Monitoring Device

United States80 participantsStarted 2019-03-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ICU patients suspected of having an abnormality of ICP undergoing monitoring with commercially-available, FDA-approved instrumentation. Exclusion Criteria: 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

What they're measuring

Non-invasive intracranial pressure (ICP) value

Timeframe: Up to 5 days after admission to ICU

Second non-invasive intracranial pressure (ICP) value

Timeframe: Up to 6 days after admission to ICU

Trial details

NCT IDNCT03865576

SponsorBoston Neurosciences

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-10-31

View on ClinicalTrials.gov More Intracranial Hypertension trials