An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an External Ventricular Drainage (EVD) Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-01-31

Brief Summary

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Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head. HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians.

The study objective is to compare the accuracy and safety profile of HS-1000, a non-invasive ICP monitor, to invasive ICP monitoring via an external ventricular drain (EVD)

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Detailed Description

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HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians

Conditions

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Presence of High Intracranial Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Patients with invasive ICP monitor (EVD)

Hospitalized patients who have already been implanted with an invasive ICP monitor. Eligible patients will be enrolled into the study and HS-1000 headset portion of the device will be placed in their ears.

Group Type EXPERIMENTAL

EVD

Intervention Type DEVICE

ICP monitoring will be done in parallel for both HS-1000 and ICP monitoring via an EVD device (per clinical protocol without any change in the patient's management). HS-1000 ICP monitoring intervals will last from 30 minutes to 6 hours, continuously depending on the patient's clinical condition. Each such interval may occur three times a day or more depending on the clinical condition of the patient.

Interventions

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EVD

ICP monitoring will be done in parallel for both HS-1000 and ICP monitoring via an EVD device (per clinical protocol without any change in the patient's management). HS-1000 ICP monitoring intervals will last from 30 minutes to 6 hours, continuously depending on the patient's clinical condition. Each such interval may occur three times a day or more depending on the clinical condition of the patient.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult men and women subjects, aged 18 years old and over at screening visit
* Patients undergoing invasive ICP monitoring via an external ventricular drainage (EVD) device for clinical management
* Survival expectancy greater than one week
* Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
* Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study

Exclusion Criteria

* Subject with ear disease, ear trauma
* Subjects with a bony abnormality (skull defect)
* Subjects with severe head trauma in which the location and/or severity of the skull fracture(s), i.e. frank skull fracture or major joint dislocations may jeopardize HeadSense monitoring procedure
* Subjects with cerebral fluid (CSF) leakage from the ear (CSF Otorrhea)
* Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
* For women of childbearing potential: pregnancy (positive pregnancy test) or breast-feeding
* Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
* Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alessandro Olivi, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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