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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05121155
Other study ID # 03843118.0.0000.5505
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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).

Study Design


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
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