Non-invasive Intracranial Pressure (ICP) Monitoring in Pediatric Patients

December 21, 2016 updated by: HeadSense Medical

Prospective Evaluation of Non-invasive Intracranial Pressure (ICP) Monitoring in Pediatric Patients Undergoing Invasive ICP Monitoring

The purpose of this study is to prospectively evaluate the accuracy and safety of non-invasive intracranial pressure (ICP) measurements using the HeadSense-1000 (HS-1000) device compared to the current invasive external ventricular device (EVD) or parenchymal (bolt) monitoring devices in the pediatric population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The HS-1000 is an innovative non-invasive intracranial pressure (ICP) monitoring device that employs advanced acoustic signal analysis to derive ICP on a continuous basis. The first version of the device was clinically validated in trials in Italy, India, and Armenia. Overall, more than 10,000 ICP measurements were collected from both patients and healthy subjects. The device is currently undergoing FDA validation in an adult cohort across eight sites in the United States.

This will be a pilot study conducted at Akron Children's Hospital. A maximum of 40 patients with severe traumatic brain injury (TBI) or neurological conditions requiring ICP monitoring will be studied over 2 years. All patients treated with either surgical ICP monitor (external ventricular drain [EVD] or subarachnoid manometer [Bolt]) are eligible for study enrollment. The HS-1000 device will be deployed as soon as possible after surgical ICP monitor placement to record and collect data in parallel with the surgical device.

To assess the accuracy and safety of the HS-1000 device as an alternative to the invasive ICP procedure, the investigators will compare ICP readings obtained by the HS-1000 monitoring system to measurements recorded by the surgical device during 15-30 minute recording sessions.

ICP readings will be recorded from both the invasive and HeadSense non-invasive ICP monitor for an aggregate of 30 minutes. During the recording sessions, a webcam will take periodic snapshots of the ICP monitor and/or bedside monitor picturing the ICP values and other clinical parameters that are displayed on screen, with a focus on blood pressure and heart rate (HR). Recording sessions will be done until an aggregate of at least 30 minutes of data are collected, depending on the patient's clinical condition. Recording sessions may be repeated over several days until the 30 minute target is reached.

The HeadSense headset is removed between recordings. Recording should be done only in case the patient's clinical condition allows it (i.e. patient is in supine position and does not require any clinical intervention or treatment at the time of the recording). In case the patient requires some clinical intervention the recording will be stopped and will be resumed only after the intervention is done and the patient's clinical condition allows resuming of the recording.

Lastly, the investigators will also place a commercial sound meter in the participant's room to collect baseline data on exposure to ambient noise within the Pediatric Intensive Care Unit (PICU) treatment environment. This data will facilitate a device-vs-ambient sound comparison, a component of the device safety profile.

Study patient demographics will be collected to include patient medical record number, age, gender, diagnosis, medical information, and the patient's clinical course pertinent to the ICP monitoring until the attending physician determines invasive ICP measurement is no longer necessary. Additional demographic, diagnostic parameters, severity of illness calculations, and procedures will be obtained from the Virtual Pediatric Systems (VPS, LLC) Pediatric Intensive Care Unit clinical outcomes database. The patient will be followed for 48 hours post ICU discharge for any adverse events.

The diagnosis of head trauma or other medical conditions indicating a need for ICP monitoring, the decision to place an intraventricular catheter and the duration of ICP monitoring are at the discretion of the patient's clinical care team and independent of this study. With the exception of simultaneous use of the non-invasive acoustical HS-1000 monitoring system and ambient noise level measurements within the patient's room, all other patient care, including clinical evaluations and treatments, is independent of this study. No HS-1000 data will be displayed and will not be used in clinical decision making.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44308
        • Akron Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females <= 18 years old admitted to the PICU whose treatment includes a surgical ICP monitor.
  • 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 an invasive ICP monitor placed Ten (10) days or before the date of recording for EVD monitor OR Five (5) days or before the date of recording for Bolt monitor
  • Subjects with more than one invasive ICP monitor in place at the time of recording
  • Ear disease/ear trauma
  • 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 with parenchyma exposed to room pressure, may jeopardize HeadSense monitoring procedure [Post-craniotomy patients with intact dura and accurate ICP values from the invasive EVD are eligible.]
  • Severe TBI that jeopardizes HS-1000 monitoring procedure
  • Cerebral spinal fluid (CSF) otorrhea
  • Allergy/Hypersensitivity to test materials
  • Pregnant or breast feeding
  • Current enrollment (or within 30 days) in another investigational device or drug study, OR receiving an investigational agent
  • Any condition that jeopardizes study participation (abnormal clinical/lab finding)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HS-1000 recording
ICP readings will be recorded from both the invasive and HeadSense non-invasive ICP monitor for an aggregate of 30 minutes. During the recording sessions, a webcam will take periodic snapshots of the ICP monitor and/or bedside monitor picturing the ICP values and other clinical parameters that are displayed on screen, with a focus on blood pressure and heart rate (HR). Recording sessions will be done until an aggregate of at least 30 minutes of data are collected, depending on the patient's clinical condition. Recording sessions may be repeated over several days until the 30 minute target is reached.
Device: HS-1000 recording

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
ICP recordings from the HS-1000 device compared to those from the invasive ICP monitor
Time Frame: 5 days of bolt insertion or 10 days of EVD insertion
5 days of bolt insertion or 10 days of EVD insertion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Safety of the HS-1000 as determined by number of reported device-related adverse events
Time Frame: Up to 48hours after last recording
Up to 48hours after last recording

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HeadSense Medical

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Akron Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael L Forbes, MD, Akron Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS-028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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