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

NCT03144219 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 133

Last updated 2022-09-30

No results posted yet for this study

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.

Conditions

  • Intracranial Hypertension

Interventions

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.

Sponsors & Collaborators

  • Braincare USA Corp

    collaborator INDUSTRY

  • University of Sao Paulo

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2023-12-15
Completion
2023-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03144219 on ClinicalTrials.gov