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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05121155
• Other study ID #: 03843118.0.0000.5505
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: November 2021
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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