Non-invasive Brain Pressure Monitoring After Trauma or Hemorrhage

Status Completed

Clinical Trial Summary

Introduction: Increased intracranial pressure (ICP) is considered to be the most important intracranial mechanism causing secondary injury in patients admitted after acute traumatic brain injury (TBI) and intracranial haemorrhage (ICB) including subarachnoid haemorrhage (SAH). Currently, ICP can be measured and monitored only using invasive techniques. The two ICP measurement methods available - intraventricular and intraparenchymal - require both a neurosurgical procedure in order to implant the catheter and probes within the brain. The invasiveness of current methods for ICP measurement limits the diagnoses reliability of many neurological conditions in which intracranial hypertension is a treatable adverse event. A reliable, accurate and precise non-invasive method to measure ICP would be of considerable clinical value, enabling ICP measurement without the need of a surgical intervention.

Aim:

The aim of this study is to validate a novel non-invasive ICP measurement device by comparing its measurement with the "gold standard" invasive ICP-measurement by intracranial probe. The device used in this study has been been developed in the Telematic Science Laboratory at the Kaunas University of Technology, Lithuania.

Methods:

The non-invasive ICP measurement method will be assessed prospectively using repeatable simultaneous non-invasive and invasive (standard with intracranial probe) ICP measurements on patients presenting with TBI and SAH. The device method is based on two-depth transcranial doppler (TCD) technique for simultaneously measuring flow velocities in the intracranial and extracranial segments of the ophthalmic artery (OA). The intracranial segment of the OA is compressed by ICP and the extracranial segment of the OA is compressed by the pressure Pe externally applied by the device. Two-depth TCD device is used as an accurate indicator of the balance point (Pe = ICP) when the measured parameters of blood flow velocity waveforms in the intracranial and extracranial segments of OA are identical. The device has the same ultrasound transmission parameters as existing TCD devices and meets all patient safety criteria.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02172703
Study type	Interventional
Source	Kantonsspital Aarau
Contact
Status	Completed
Phase	N/A
Start date	February 2014
Completion date	July 2015

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.