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Prospective Evaluation of the Non-invasive ICP HeadSense Monitor in TBI Patients Undergoing Invasive ICP Monitoring

Primary Purpose

Brain Injuries, Intracranial Hypertension

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
HS-1000
Sponsored by
HeadSense Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Injuries focused on measuring brain injuries, noninvasive monitoring, intracranial pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have an invasive ICP monitoring
  • Male or Female in the age range of 18 years and older

Exclusion Criteria:

  • Local infection in the ear.
  • Pregnant/lactating women

Sites / Locations

  • St. Elisabeth Ziekenhuis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HS-1000 recording

Arm Description

ICP monitoring will be done in parallel for both HS-1000 and ICP monitoring via an invasive monitoring device (per clinical protocol without any change in the patient's management). HS-1000 ICP monitoring intervals will last from 30 minutes to 48 hours, continuously depending on the patient's clinical condition.

Outcomes

Primary Outcome Measures

Number of ICP values obtained by the HS device that correlate to ICP using current standards

Secondary Outcome Measures

Full Information

First Posted
May 12, 2016
Last Updated
May 13, 2016
Sponsor
HeadSense Medical
Collaborators
Elisabeth-TweeSteden Ziekenhuis
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1. Study Identification

Unique Protocol Identification Number
NCT02773862
Brief Title
Prospective Evaluation of the Non-invasive ICP HeadSense Monitor in TBI Patients Undergoing Invasive ICP Monitoring
Official Title
Prospective Evaluation of the Non-invasive ICP HeadSense Monitor in TBI Patients Undergoing Invasive ICP Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HeadSense Medical
Collaborators
Elisabeth-TweeSteden Ziekenhuis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with severe traumatic brain injury (TBI) are admitted to the intensive care unit (ICU). Under certain condition (such as a impaired consciousness) the intracranial pressure (ICP) is measured. An increase in the intracranial pressure might suggest secondary neurological deterioration and is considered an alarming symptom. Current practice is to insert an invasive monitor through a burr hole in the skull with the risk of bleeding and infection. Using a new type of ICP monitor (HeadSense) it is possible to measure ICP non-invasively through an acoustic signal.
Detailed Description
In this pilot study, the investigators will prospectively collect relevant clinical data on 15 TBI patients with an inserted invasive ICP monitor. Each enrolled patient will be monitored in parallel to the invasive ICP monitor with the HeadSense's ICP monitor. Subjects who meet the study's inclusion and exclusion criteria will be enrolled in the study. Family members will be asked for consent. The patient's clinical condition will be recorded in a case record form (CRF). Once the patient is inclined with his upper body 30 degrees to the bed and the invasive ICP monitor displays the pressure values, the clinical procedure can begin. Once the HeadSense's monitor is calibrated it is connected to the front end that is placed on the patient's ears. Each recording session will be ½-48 hours long, depending on the patient's clinical condition. In case the ICP monitor is still inserted to the patient's brain in the following day, recording sessions will continue until the ICP monitor is removed. After the study, the patient's ears will be examined for internal ear infection or irritation that might be caused by the ear buds. Patient adverse events will be documented on the case report forms in case they occurred, and the family or advocate of the patient will be informed. In case of clinical relevant adverse event, appropriate clinical action will be taken. As the procedure does not affect the patient management, there is no need to provide any specific medical care related to the trial. Patients will receive the relevant clinical care related to their clinical management, without any consideration to their participation in the trial. Once the data collection is done, results will be analyzed by comparing ICP readings from both devices. The end point of the study is to collect at least half an hour of ICP monitoring for each participant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Intracranial Hypertension
Keywords
brain injuries, noninvasive monitoring, intracranial pressure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HS-1000 recording
Arm Type
Experimental
Arm Description
ICP monitoring will be done in parallel for both HS-1000 and ICP monitoring via an invasive monitoring device (per clinical protocol without any change in the patient's management). HS-1000 ICP monitoring intervals will last from 30 minutes to 48 hours, continuously depending on the patient's clinical condition.
Intervention Type
Device
Intervention Name(s)
HS-1000
Primary Outcome Measure Information:
Title
Number of ICP values obtained by the HS device that correlate to ICP using current standards
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have an invasive ICP monitoring Male or Female in the age range of 18 years and older Exclusion Criteria: Local infection in the ear. Pregnant/lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guus Schoonman, MD, PhD
Organizational Affiliation
St. Elisabeth/Tweesteden Hospital Tilburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Elisabeth Ziekenhuis
City
Tilburg
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prospective Evaluation of the Non-invasive ICP HeadSense Monitor in TBI Patients Undergoing Invasive ICP Monitoring

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