Validation of Non-Invasive Intracranial Pressure (ICP) Monitoring Device
| Status: | Active, not recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/9/2019 |
| Start Date: | March 1, 2019 |
| End Date: | October 31, 2019 |
Validation of a Non-Invasive Intracranial Pressure (ICP) Device by Comparison With Implanted Intracranial Pressure Monitoring Instrumentation or Lumbar Puncture
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.
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.
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.
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
We found this trial at
4
sites
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Emory University Hospital As the largest health care system in Georgia and the only health...
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