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

NCT02773862 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-05-17

No results posted yet for this study

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.

Conditions

  • Brain Injuries
  • Intracranial Hypertension

Interventions

DEVICE

HS-1000

Sponsors & Collaborators

  • Elisabeth-TweeSteden Ziekenhuis

    collaborator OTHER

  • HeadSense Medical

    lead INDUSTRY

Principal Investigators

  • Guus Schoonman, MD, PhD · St. Elisabeth/Tweesteden Hospital Tilburg

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02773862 on ClinicalTrials.gov