Non-invasive ONSD-based Neuromonitoring in a Neurointensive Care Setting

Study Overview
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Brief Summary
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Intensive care patients with established invasive intracranial neuromonitoring due to neurotrauma are subjected to a repeated non-invasive sonographic recording of the optic-nerve-sheath-diameter (ONSD). The recorded images are analyzed through a machine-learning-algorithm and an experienced ultrasound operator. Results are correlated to the parallel recorded intracranial pressure (ICP). The study aims to establish ONSD as a supplementary for raised ICP.

Detailed Description
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During the intensive care stay, patients with implemented invasive intracranial pressure monitoring will have sonographic recording of the optic nerve sheath (video clip) with a parallel recording of the underlying ICP. The obtained image material is then i) analyzed by a machine-learning algorithm and ii) manually by 2 blinded differently experienced examiners (expert, novice) with respect to the ONSD. For the manual procedure, three individual measurements are made for each eye and the mean value is determined. Subsequently, the measured values of the two examiners and the automated procedure are correlated with the ICP recorded during the sonographic examination.

Official Title
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Non-invasive Neuromonitoring Through Point-of-care Determination of ONSD and Assessment of Dynamic Properties of the Optic Nerve Sheath in a Neurointensive Care Setting

Conditions
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Trauma, Brain, Subarachnoid Hemorrhage, Intracranial Hypertension

Intervention / Treatment
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* Diagnostic Test: Sonographic determination of the optic nerve sheath diameter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Traumatic or non-traumatic (e.g. SAH) brain injury Established invasive intracranial pressure monitoring (either intraparenchymal or Intraventricular) Exclusion Criteria: Soft tissue damage to orbital or periorbital region Fracture of the Orbita Status post decompressive craniectomy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single center, prospective, open diagnostic study, proof-of-concept
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pathologic and non-pathologic intracranial pressure<br>Sonographic determination of Optic nerve sheath. Parallel recording of ICP | Diagnostic Test: Sonographic determination of the optic nerve sheath diameter<br>* Ultrasound-based determination of the optic nerve sheath diameter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sonographic monitoring of optic nerve sheath | Repeated ultrasound-based measurement of optic nerve sheath in millimeter (mm) | Single measurement post-trauma up to day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Invasively measured intracranial pressure | Continuously recorded invasively (intra-parenchymal, intra-ventricular) determined intracranial pressure (mmHg) | Continuously from time of admission up to day 10 |