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Completed

NCT Number: NCT05121155

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Other names: Estimation of Intracranial Hypertension using non-invasive methods

Primary outcomes

  1. Comparison between ICP morphology between a non invasive (Brain4care [B4c]) and a invasive (intraventricular) method

    Time frame: At least 30 minutes for every patient

    Parameter of the ICP wave between methods were compared (P2/P1 ratio)

  2. Comparison between ICP morphology between a non invasive (Brain4care [B4c]) and a invasive (intraventricular) method

    Time frame: At least 30 minutes for every patient

    Parameter of the ICP wave between methods were compared (Time-to-Peak)

Secondary outcomes

  1. Estimation of Intracranial Hypertension using Transcranial Doppler

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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.

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 16, 2021
Registry last updated
Nov 16, 2021

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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