Intracranial Hypertension, Stroke, Stroke Hemorrhagic, Stroke, Ischemic, Subarachnoid Hemorrhage
Conditions
Keywords
non invasive icp monitor, icp wave morphology
Brief summary
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.
Interventions
DEVICEICP 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
Sponsors
Federal University of São Paulo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison between ICP morphology between a non invasive (Brain4care [B4c]) and a invasive (intraventricular) method | At least 30 minutes for every patient | Parameter of the ICP wave between methods were compared (P2/P1 ratio) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimation of Intracranial Hypertension using Transcranial Doppler | At least 5 minutes after EVD closure | We measured the Pulsatility Index using transcranial Doppler (TCD) and calculated a ROC curve to calculate its discriminatory power |
| Estimation of Intracranial Hypertension using optic nerve sheath diameter (ONSD) | At least 5 minutes after EVD closure | We measured the ONSD for both eyes and calculated a ROC curve to evaluate its discriminatory power in detecting Intracranial Hypertension |
| Estimation of Intracranial Hypertension using a non-invasive ICP wave parameter (P2/P1 ratio). | At least 5 minutes after EVD closure | 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 |
| Estimation of Intracranial Hypertension using a non-invasive ICP wave parameter (Time-to_peak). | At least 5 minutes after EVD closure | We measured the mean TTP and calculated a ROC curve to evaluate its discriminatory power in detecting Intracranial Hypertension. |
| Estimation of Intracranial Hypertension using a 5-point visual scale designed for Computed Tomography (CT) | At least 5 minutes after EVD closure | We calculated the points in the scale and built a ROC curve to evaluate its discriminatory power in detecting Intracranial Hypertension |
Countries
Brazil
Outcome results
None listed