Abnormality of Intracranial Pressure, Intracranial Hypertension
Conditions
Keywords
ICP, Papilledema, Neurological Intensive Care
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.
Detailed description
This study is designed to validate intracranial pressure measurements obtained with a novel, self-calibrating, non-invasive, intracranial pressure measuring (ICP) device based on trans-cranial Doppler technology. The ophthalmic artery is utilized as a natural ICP sensor. Up to 80 subjects will be recruited in 4 centers to achieve a power of 90% and a p\<0.05 compared to the values obtained from (a) patients in an 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. At least two comparative readings, separated by an hour or more, will be obtained from each subject.
Interventions
DIAGNOSTIC_TESTNon-invasive ICP measurement
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
Sponsors
Boston Neurosciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-invasive intracranial pressure (ICP) value | Up to 5 days after admission to ICU | ICP value measured using novel non-invasive measurement device |
| Second non-invasive intracranial pressure (ICP) value | Up to 6 days after admission to ICU | A second measurement of ICP using novel non-invasive ICP measurement device |
Countries
United States
Outcome results
None listed