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A Novel Non-invasive Technique of Cerebral Compliance and Auto-regulation Assessment

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ClinicalTrials.gov Identifier: NCT03144219
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : September 30, 2022
Brain4Care USA Corp.
Information provided by (Responsible Party):
Sergio Brasil, MD, University of Sao Paulo

Brief Summary:

Introduction: Intracranial pressure (ICP) monitoring is essential in several medical situations, however, currently there is an invasive technique, costly, not widely available and sometimes contraindicated. Transcranial Doppler (TCD) pulsatility index (PI) measure can provide indirect information on the cerebrovascular resistance (CVR) augmentation, which is present concomitantly with intracranial hypertension (ICH). The hypothesis that PI measure accurately indicates cerebral compliance impairment (CCI) has been not assessed by large studies currently, and would be of value as a non invasive technique to denote earlier installing of therapeutics to prevent the effects of ICH. Likewise, a novel technique of intracranial compliance assessment by means of an external sensor has been developed, still in need of being prospectively studied.

Objective: The present study aims to assess PI accuracy indicating CCI, and dynamic cerebral auto regulation (dCAR) during internal jugular veins (IJVs) compression observed by both invasive and non-invasive techniques.

Methods: A prospective, observational controlled study, including critical neurological patients with ICP monitoring in normal range (under 20 mmHg). Initially, dCAR is monitored, then, the IJVs are compressed for 60 seconds with ultrasound guidance. We evaluate optic nerve sheath prior to intervention, and dCAR, ICP values, ICP waveforms and PI variation at different times, correlating results.

Condition or disease Intervention/treatment
Intracranial Hypertension Diagnostic Test: Transcranial Doppler (TCD) ultrasound monitoring Diagnostic Test: Non invasive intracranial compliance monitoring

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Study Type : Observational
Estimated Enrollment : 133 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Novel Non-invasive Technique of Cerebral Compliance and Auto-regulation Assessment
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 15, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

Intervention Details:
  • Diagnostic Test: Transcranial Doppler (TCD) ultrasound monitoring
    TCD monitoring comatose patients in ICU looking for signs of impaired cerebral compliance
  • Diagnostic Test: Non invasive intracranial compliance monitoring
    A sensor of cardiac beat by beat cranial dilation will be used for monitoring intracranial compliance, in non-invasive fashion.

Primary Outcome Measures :
  1. Impaired cerebral compliance [ Time Frame: 10 minutes ]
    Performing ICP and TCD monitoring simultaneously during jugular compression, matching waveform behavior through computer software QL Online

Secondary Outcome Measures :
  1. Impaired cerebral auto-regulation [ Time Frame: 10 minutes ]
    The same procedure detailed above, matching mean arterial pressure and CBFv in the computer software QL Online

  2. Non-invasive intracranial compliance monitoring [ Time Frame: 10 minutes ]
    The same approaches described above, using the non-invasive Brain4Care system concomitantly.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neurological patients (GCS 5 and under) of any cause, gender or age.

Inclusion Criteria:

Patients whose underwent ICP monitoring displaying both ICP curves and values.

Exclusion Criteria:

Patients whose display absence of insonation window

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144219

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Contact: Sergio Brasil, MDMSc +5511981210990 sbrasil@usp.br

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University of São Paulo Recruiting
São Paulo, Brazil, 06630-060
Contact: Sergio Brasil    1136287231      
Sponsors and Collaborators
University of Sao Paulo
Brain4Care USA Corp.
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sergio Brasil, MD, Sergio Brasil, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03144219    
Other Study ID Numbers: 66721217.0.0000.0068
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: September 30, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sergio Brasil, MD, University of Sao Paulo:
intracranial pressure
transcranial Doppler
jugular compression
cerebral compliance
Additional relevant MeSH terms:
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Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases