Clinical trial NCT03865576: Validation of Non-Invasive Intracranial Pressure (ICP) Monitoring Device
Official title: Validation of a Non-Invasive Intracranial Pressure (ICP) Device by Comparison With Implanted Intracranial Pressure Monitoring Instrumentation or Lumbar Puncture
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Hypertension
Abnormality of Intracranial Pressure
Keywords: ICP
Papilledema
Neurological Intensive Care
Lead sponsor: Boston Neurosciences
Sponsor class: INDUSTRY
First posted: 2019-03-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in an ICU who meet clinical criteria for invasive ICP measurement,

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.

Eligibility criteria: 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

Primary outcomes:
measure: Non-invasive intracranial pressure (ICP) value
timeFrame: Up to 5 days after admission to ICU
measure: Second non-invasive intracranial pressure (ICP) value
timeFrame: Up to 6 days after admission to ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Honor Health Research Institute
state: Arizona
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Philadelphia
country: United States
facility: Thomas Jefferson Hospital
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Boston Neurosciences
name: T Forcht Dagi, MD, DMedSc
role: STUDY_DIRECTOR
References: