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

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ClinicalTrials.gov Identifier: NCT02773862
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : May 17, 2016
Sponsor:
Collaborator:
Elisabeth-TweeSteden Ziekenhuis
Information provided by (Responsible Party):
HeadSense Medical

Study Description
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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.

Condition or disease Intervention/treatment Phase
Brain Injuries Intracranial Hypertension Device: HS-1000 Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Evaluation of the Non-invasive ICP HeadSense Monitor in TBI Patients Undergoing Invasive ICP Monitoring
Study Start Date : June 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: HS-1000 recording
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.
 Device: HS-1000


Outcome Measures
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Primary Outcome Measures :
  1. Number of ICP values obtained by the HS device that correlate to ICP using current standards [ Time Frame: 30 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773862


Locations
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Netherlands
St. Elisabeth Ziekenhuis
Tilburg, Netherlands
Sponsors and Collaborators
HeadSense Medical
Elisabeth-TweeSteden Ziekenhuis
Investigators
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Principal Investigator: Guus Schoonman, MD, PhD St. Elisabeth/Tweesteden Hospital Tilburg
More Information
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Responsible Party: HeadSense Medical
ClinicalTrials.gov Identifier: NCT02773862    
Other Study ID Numbers: HS-012
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by HeadSense Medical:
brain injuries
noninvasive monitoring
intracranial pressure
Additional relevant MeSH terms:
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Brain Injuries
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries