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

Sponsor
Federal University of São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT05121155
Collaborator
(none)
18
Enrollment
1
Location
13
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: ICP wave morphology comparison between a non-invasive (Brain4care) and a invasive method

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
18 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Brain Skull Deformation as a Non-invasive Intracranial Pressure (ICP) Measure: Comparison Between Invasive and Noninvasive Methods.
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Mar 30, 2020
Actual Study Completion Date :
Mar 30, 2020

Outcome Measures

Primary Outcome Measures

  1. Comparison between ICP morphology between a non invasive (Brain4care [B4c]) and a invasive (intraventricular) method [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 [At least 30 minutes for every patient]

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

Secondary Outcome Measures

  1. Estimation of Intracranial Hypertension using Transcranial Doppler [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) [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). [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). [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) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Federal University of São PauloSão PauloBrazil04024-002

Sponsors and Collaborators

  • Federal University of São Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gisele Sampaio Silva, Profa. Dra Gisele Sampaio Silva, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT05121155
Other Study ID Numbers:
  • 03843118.0.0000.5505
First Posted:
Nov 16, 2021
Last Update Posted:
Nov 16, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Gisele Sampaio Silva, Profa. Dra Gisele Sampaio Silva, Federal University of São Paulo
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2021