Clinical trial NCT05121155: Brain Skull Deformation as a Non-invasive Intracranial Pressure (ICP) Measure
Official title: Brain Skull Deformation as a Non-invasive Intracranial Pressure (ICP) Measure: Comparison Between Invasive and Noninvasive Methods.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subarachnoid Hemorrhage
Stroke
Stroke, Ischemic
Stroke Hemorrhagic
Intracranial Hypertension
Keywords: non invasive icp monitor
icp wave morphology
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From a total of 30 patients with invasive ICP monitor evaluated in our hospital between March 2019 and March 2020 (pre-Covid-19), 18 patients fulfilled inclusion and exclusion criteria. A total of 60 monitorizations were performed. We included 14 patients with subarachnoid hemorrhage (SAH), one with IS, and three with ICH. All SAH were aneurysmatic, all ICH were hypertensives and the only IS was a cardioembolic malignant middle cerebral artery stroke. There were no side effects from the use of the noninvasive method.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Comparison between ICP morphology between a non invasive (Brain4care [B4c]) and a invasive (intraventricular) method
timeFrame: At least 30 minutes for every patient
measure: Comparison between ICP morphology between a non invasive (Brain4care [B4c]) and a invasive (intraventricular) method
timeFrame: At least 30 minutes for every patient
Secondary outcomes:
measure: Estimation of Intracranial Hypertension using Transcranial Doppler
timeFrame: At least 5 minutes after EVD closure
measure: Estimation of Intracranial Hypertension using optic nerve sheath diameter (ONSD)
timeFrame: At least 5 minutes after EVD closure
measure: Estimation of Intracranial Hypertension using a non-invasive ICP wave parameter (P2/P1 ratio).
timeFrame: At least 5 minutes after EVD closure
measure: Estimation of Intracranial Hypertension using a non-invasive ICP wave parameter (Time-to_peak).
timeFrame: At least 5 minutes after EVD closure
measure: Estimation of Intracranial Hypertension using a 5-point visual scale designed for Computed Tomography (CT)
timeFrame: At least 5 minutes after EVD closure
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
References:
citation: Moraes FM, Silva GS. Noninvasive intracranial pressure monitoring methods: a critical review. Arq Neuropsiquiatr. 2021 May;79(5):437-446. doi: 10.1590/0004-282X-ANP-2020-0300.
citation: de Moraes FM, Rocha E, Barros FCD, Freitas FGR, Miranda M, Valiente RA, de Andrade JBC, Neto FEAC, Silva GS. Waveform Morphology as a Surrogate for ICP Monitoring: A Comparison Between an Invasive and a Noninvasive Method. Neurocrit Care. 2022 Aug;37(1):219-227. doi: 10.1007/s12028-022-01477-4. Epub 2022 Mar 24.