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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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. R
Sponsor: HeadSense Medical

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Safety of the HS-1000 as determined by number of reported device-related adverse events [ Time Frame: Up to 48hours after last recording ]

Original Secondary Outcome: Same as current

Information By: HeadSense Medical

Dates:
Date Received: February 22, 2016
Date Started: August 2016
Date Completion:
Last Updated: December 21, 2016
Last Verified: December 2016