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Subarachnoid HemorrhageNCT05121155

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

An observational study of Subarachnoid Hemorrhage and Stroke, run by Federal University of São Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Subarachnoid Hemorrhage, Stroke, Stroke, Ischemic
What is being tested?
ICP wave morphology comparison between a non-invasive (Brain4care) and a invasive method
Type of treatment
Medical device
How many people
18 participants
Where
1 siteBrazil
Study dates
1 Mar 2019to 30 Mar 2020
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Federal University of São Paulo

    São Paulo, 04024-002

Other trials in Brazil

About this study

Official title: 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.

Being tested
ICP wave morphology comparison between a non-invasive (Brain4care) and a invasive method
Keywords
non invasive icp monitor, icp wave morphology
Medical subject headings
Subarachnoid Hemorrhage, Stroke, Ischemic Stroke, Hemorrhagic Stroke, Intracranial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICP wave morphology comparison between a non-invasive (Brain4care) and a invasive methodDevice

    Also called Estimation of Intracranial Hypertension using non-invasive 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: At least 30 minutes for every patient

  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 (Time-to-Peak)

    Measured: At least 30 minutes for every patient

Secondary outcomes (5)

  1. 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

    Measured: At least 5 minutes after EVD closure

  2. 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

    Measured: At least 5 minutes after EVD closure

  3. 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

    Measured: At least 5 minutes after EVD closure

  4. 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.

    Measured: At least 5 minutes after EVD closure

  5. 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

    Measured: At least 5 minutes after EVD closure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2021
  2. Study start1 Mar 2019
  3. Primary completion30 Mar 2020
  4. Study completion30 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
18 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT05121155
Sponsor's protocol ID
03843118.0.0000.5505
Status last verified
Nov 2021
First submitted
24 Oct 2021
Last updated
16 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: As soon as the data are published, we intend to share it.

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.

    PubMed 34161530

  • 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.

    PubMed 38355918

  • 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.

    PubMed 35332426

Questions about this trial

What is this clinical trial studying?

An observational study of Subarachnoid Hemorrhage and Stroke, run by Federal University of São Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison between ICP morphology between a non invasive (Brain4care [B4c]) and a invasive (intraventricular) method (time frame: At least 30 minutes for every patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05121155, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.

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