NCT05121155

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-03-30
• Completion: 2020-03-30
• First posted: 2021-11-16
• Last updated: 2021-11-16

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated device study