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

• Conditions: Intracranial Hypertension; Abnormality of Intracranial Pressure
• Interventions: Diagnostic Test: Non-invasive ICP measurement

• Registration Number: NCT03865576
• Lead Sponsor: Boston Neurosciences

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.

Study Timeline

• Study First Submitted: 2019-02-28
• Status Verified: 2019-03
• Study Start: 2019-03-01
• Study First Submitted QC: 2019-03-05
• Last Update Submitted: 2019-03-05
• Study First Posted: 2019-03-07
• Last Update Posted: 2019-03-07
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thomas Jefferson University	Non-invasive ICP measurement	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.
Honor Health in Phoenix	Non-invasive ICP measurement	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.
University of Washington	Non-invasive ICP measurement	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
Emory University Hospital in Atlanta	Non-invasive ICP measurement	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

Primary Outcome Measures

Name	Time	Method
Non-invasive intracranial pressure (ICP) value	Up to 5 days after admission to ICU	ICP value measured using novel non-invasive measurement device
Second non-invasive intracranial pressure (ICP) value	Up to 6 days after admission to ICU	A second measurement of ICP using novel non-invasive ICP measurement device

Trial Locations

Locations (4)

Honor Health Research Institute; 🇺🇸 Phoenix, Arizona, United States

Thomas Jefferson Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

University of Washington; 🇺🇸 Seattle, Washington, United States