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

NCT05121155 | Completed FDA Device

• 1 other identifier: 03843118.0.0000.5505
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

non invasive icp monitor; icp wave morphology

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Estimation of Intracranial Hypertension using Transcranial Doppler

  At least 5 minutes after EVD closure

• Estimation of Intracranial Hypertension using optic nerve sheath diameter (ONSD)

  At least 5 minutes after EVD closure

• Estimation of Intracranial Hypertension using a non-invasive ICP wave parameter (P2/P1 ratio).

  At least 5 minutes after EVD closure

• Estimation of Intracranial Hypertension using a non-invasive ICP wave parameter (Time-to_peak).

  At least 5 minutes after EVD closure

• Estimation of Intracranial Hypertension using a 5-point visual scale designed for Computed Tomography (CT)

  At least 5 minutes after EVD closure

Interventions

ICP wave morphology comparison between a non-invasive (Brain4care) and a invasive method DEVICE

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

Also known as: Estimation of Intracranial Hypertension using non-invasive methods

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, 04024-002, Brazil

Location

Related Publications (3)

• 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.

  PMID: 34161530 RESULT

• de Moraes FM, Brasil S, Frigieri G, Robba C, Paiva W, Silva GS. ICP wave morphology as a screening test to exclude intracranial hypertension in brain-injured patients: a non-invasive perspective. J Clin Monit Comput. 2024 Aug;38(4):773-782. doi: 10.1007/s10877-023-01120-3. Epub 2024 Feb 14.

  PMID: 38355918 DERIVED

• 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.

  PMID: 35332426 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Stroke; Ischemic Stroke; Hemorrhagic Stroke; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profa. Dra Gisele Sampaio Silva

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: November 16, 2021
• Study Start: March 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

BR (1)