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

Completed

• Conditions: Subarachnoid Hemorrhage; Stroke, Ischemic; Stroke Hemorrhagic; Intracranial Hypertension; Stroke

• Registration Number: NCT05121155
• Lead Sponsor: Federal University of São Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Study First Submitted: 2021-10-24
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-03
• Last Update Submitted: 2021-11-03
• Study First Posted: 2021-11-16
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 (Time-to-Peak)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil