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.

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Subarachnoid Hemorrhage; Intracranial Hypertension; Stroke, Ischemic; Stroke Hemorrhagic
• Intervention / Treatment: Device: ICP wave morphology comparison between a non-invasive (Brain4care) and a invasive method

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04024-002
    • Federal University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: October 24, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: non invasive icp monitor; icp wave morphology
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Stroke; Ischemic Stroke; Hemorrhage; Subarachnoid Hemorrhage; Intracranial Hypertension; Hemorrhagic Stroke
• Other Study ID Numbers: 03843118.0.0000.5505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: As soon as the data are published, we intend to share it.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No