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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Validation of a Non-Invasive Intracranial Pressure (ICP) Device by Comparison With Implanted Intracranial Pressure Monitoring Instrumentation or Lumbar Puncture

Conditions
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Intracranial Hypertension, Abnormality of Intracranial Pressure

Intervention / Treatment
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* Diagnostic Test: Non-invasive ICP measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thomas Jefferson University<br>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<br>* 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<br>|
| Honor Health in Phoenix<br>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<br>* 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<br>|
| Emory University Hospital in Atlanta<br>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<br>* 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<br>|
| University of Washington<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICP, Papilledema, Neurological Intensive Care