Brain Skull Deformation as a Non-invasive Intracranial Pressure (ICP) Measure

Study Overview
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Brief Summary
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Background: Although placement of an intra-cerebral catheter remains the gold standard method for measuring intracranial pressure (ICP), there are several limitations to the method. Objectives: The main objective of this study was to compare the correlation and the agreement of the wave morphology between the ICP (standard ICP monitoring) and a new nICP monitor in patients admitted with stroke. Our secondary objective was to estimate the accuracy of four non-invasive methods to assess intracranial hypertension. Methods: We prospectively collected data of adults admitted to an intensive care unit (ICU) with subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH) or ischemic stroke (IS) in whom invasive ICP monitoring placed. Measures had been simultaneously collected from the following non-invasive indices: optic nerve sheath diameter (ONSD), pulsatility index (PI) using transcranial Doppler (TCD), a 5-point visual scale designed for Computed Tomography (CT) and two parameters (time-to-peak [TTP] and P2/P1 ratio) of a non-invasive ICP wave morphology monitor (Brain4care[B4c]). Intracranial hypertension was defined as an invasively measured ICP > 20 mmHg for at least five minutes.

Official Title
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Brain Skull Deformation as a Non-invasive Intracranial Pressure (ICP) Measure: Comparison Between Invasive and Noninvasive Methods.

Conditions
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Subarachnoid Hemorrhage, Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Intracranial Hypertension

Intervention / Treatment
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* Device: ICP wave morphology comparison between a non-invasive (Brain4care) and a invasive method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Adult inpatients from a dedicated neurological intensive care unit with ischemic (IS) or hemorrhagic stroke who needed invasive ICP monitoring were prospectively evaluated from March 2019 to March 2020 (before the COVID-19 pandemic). Exclusion Criteria: We excluded patients with chronic neurological diseases (demyelinating diseases, chronic hydrocephalus, pseudotumor brain), suspected brain death, and patients monitored with non-ventricular sensors (e.g., subdural or epidural).

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ICP wave morphology comparison between a non-invasive (Brain4care) and a invasive method|We prospectively collected data of adults admitted to an intensive care unit (ICU) with subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH) or ischemic stroke (IS) in whom invasive ICP monitoring placed. Measures had been simultaneously collected from the following non-invasive indices: optic nerve sheath diameter (ONSD), pulsatility index (PI) using transcranial Doppler (TCD), a 5-point visual scale designed for Computed Tomography (CT) and two parameters (time-to-peak [TTP] and P2/P1 ratio) of a non-invasive ICP wave morphology monitor (Brain4care[B4c]). Intracranial hypertension was defined as an invasively measured ICP > 20 mmHg for at least five minutes|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between ICP morphology between a non invasive (Brain4care [B4c]) and a invasive (intraventricular) method | Parameter of the ICP wave between methods were compared (P2/P1 ratio) | At least 30 minutes for every patient | 
| Comparison between ICP morphology between a non invasive (Brain4care [B4c]) and a invasive (intraventricular) method | Parameter of the ICP wave between methods were compared (Time-to-Peak) | At least 30 minutes for every patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of Intracranial Hypertension using Transcranial Doppler | We measured the Pulsatility Index using transcranial Doppler (TCD) and calculated a ROC curve to calculate its discriminatory power | At least 5 minutes after EVD closure | 
| Estimation of Intracranial Hypertension using optic nerve sheath diameter (ONSD) | We measured the ONSD for both eyes and calculated a ROC curve to evaluate its discriminatory power in detecting Intracranial Hypertension | At least 5 minutes after EVD closure | 
| Estimation of Intracranial Hypertension using a non-invasive ICP wave parameter (P2/P1 ratio). | We measured the mean P2/P1 ratio and calculated a ROC curve to evaluate its discriminatory power in detecting Intracranial Hypertension. We calculated the points in the scale and built a ROC curve to evaluate its discriminatory power in detecting Intracranial Hypertension | At least 5 minutes after EVD closure | 
| Estimation of Intracranial Hypertension using a non-invasive ICP wave parameter (Time-to_peak). | We measured the mean TTP and calculated a ROC curve to evaluate its discriminatory power in detecting Intracranial Hypertension. | At least 5 minutes after EVD closure | 
| Estimation of Intracranial Hypertension using a 5-point visual scale designed for Computed Tomography (CT) | We calculated the points in the scale and built a ROC curve to evaluate its discriminatory power in detecting Intracranial Hypertension | At least 5 minutes after EVD closure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non invasive icp monitor, icp wave morphology