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

Boston Neurosciences

Status: Unknown

Conditions: Abnormality of Intracranial Pressure; Intracranial Hypertension

Treatments: Diagnostic Test: Non-invasive ICP measurement

Study type: Observational

Funder types: Industry

Identifiers

NCT03865576

nICP-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 4 patient groups

Thomas Jefferson University

Description:

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.

Treatment:

Diagnostic Test: Non-invasive ICP measurement

Honor Health in Phoenix

Description:

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.

Treatment:

Diagnostic Test: Non-invasive ICP measurement

Emory University Hospital in Atlanta

Description:

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

Treatment:

Diagnostic Test: Non-invasive ICP measurement

University of Washington

Description:

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

Treatment:

Diagnostic Test: Non-invasive ICP measurement