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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive ICP measurement | Diagnostic 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
History of:
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Patients hospitalized in an ICU who meet clinical criteria for invasive ICP measurement,
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| Name | Affiliation | Role |
|---|---|---|
| T Forcht Dagi, MD, DMedSc | Boston Neurosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honor Health Research Institute | Phoenix | Arizona | 85258 | United States | ||
| Emory University Hospital |
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| ID | Term |
|---|---|
| D019586 | Intracranial Hypertension |
| D010211 | Papilledema |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009901 | Optic Nerve Diseases |
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| Atlanta |
| Georgia |
| 30322 |
| United States |
| Thomas Jefferson Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |