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

NCT03144219 | Unknown

• 1 other identifier: 66721217.0.0000.0068
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Hypertension

Keywords

intracranial pressure; transcranial Doppler; jugular compression; cerebral compliance

Outcome Measures

Primary Outcomes (1)

• Impaired cerebral compliance

  Performing ICP and TCD monitoring simultaneously during jugular compression, matching waveform behavior through computer software QL Online

  10 minutes

Secondary Outcomes (2)

• Impaired cerebral auto-regulation

  10 minutes

• Non-invasive intracranial compliance monitoring

  10 minutes

Interventions

Transcranial Doppler (TCD) ultrasound monitoring DIAGNOSTIC_TEST

TCD monitoring comatose patients in ICU looking for signs of impaired cerebral compliance

Non invasive intracranial compliance monitoring DIAGNOSTIC_TEST

A sensor of cardiac beat by beat cranial dilation will be used for monitoring intracranial compliance, in non-invasive fashion.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neurological patients (GCS 5 and under) of any cause, gender or age.

You may qualify if:

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

You may not qualify if:

• Patients whose display absence of insonation window

Sponsors & Collaborators

• University of Sao Paulo: lead
• Braincare USA Corp: collaborator

Study Sites (1)

University of São Paulo

São Paulo, 06630-060, Brazil

RECRUITING

Related Publications (9)

• Dahlqvist MB, Andres RH, Raabe A, Jakob SM, Takala J, Dunser MW. Brain herniation in a patient with apparently normal intracranial pressure: a case report. J Med Case Rep. 2010 Aug 31;4:297. doi: 10.1186/1752-1947-4-297.

  PMID: 20807427 BACKGROUND

• Bellner J, Romner B, Reinstrup P, Kristiansson KA, Ryding E, Brandt L. Transcranial Doppler sonography pulsatility index (PI) reflects intracranial pressure (ICP). Surg Neurol. 2004 Jul;62(1):45-51; discussion 51. doi: 10.1016/j.surneu.2003.12.007.

  PMID: 15226070 BACKGROUND

• O'Brien NF, Maa T, Reuter-Rice K. Noninvasive screening for intracranial hypertension in children with acute, severe traumatic brain injury. J Neurosurg Pediatr. 2015 Oct;16(4):420-5. doi: 10.3171/2015.3.PEDS14521. Epub 2015 Jul 3.

  PMID: 26140576 BACKGROUND

• Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.

  PMID: 18183564 BACKGROUND

• Paschoal FM Jr, Bor-Seng-Shu E, Teixeira MJ. Transcranial Doppler ultrasonography with jugular vein compression can detect impairment of intracranial compliance. Clin Neurol Neurosurg. 2013 Jul;115(7):1196-8. doi: 10.1016/j.clineuro.2012.09.028. Epub 2012 Nov 3. No abstract available.

  PMID: 23128012 RESULT

• Brasil S, Czosnyka M, Paiva WS, Frigieri G. Exploring Cerebrospinal Compensatory Zones Using a Noninvasive Approach. Neurocrit Care. 2025 Dec;43(3):834-841. doi: 10.1007/s12028-025-02320-2. Epub 2025 Jul 14.

  PMID: 40659917 DERIVED

• 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.

  PMID: 38355918 DERIVED

• Frigieri G, Robba C, Machado FS, Gomes JA, Brasil S. Application of non-invasive ICP waveform analysis in acute brain injury: Intracranial Compliance Scale. Intensive Care Med Exp. 2023 Jan 27;11(1):5. doi: 10.1186/s40635-023-00492-9. No abstract available.

  PMID: 36703025 DERIVED

• Brasil S, Frigieri G, Taccone FS, Robba C, Solla DJF, de Carvalho Nogueira R, Yoshikawa MH, Teixeira MJ, Malbouisson LMS, Paiva WS. Noninvasive intracranial pressure waveforms for estimation of intracranial hypertension and outcome prediction in acute brain-injured patients. J Clin Monit Comput. 2023 Jun;37(3):753-760. doi: 10.1007/s10877-022-00941-y. Epub 2022 Nov 18.

  PMID: 36399214 DERIVED

MeSH Terms

Conditions

Intracranial Hypertension

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Central Study Contacts

Sergio Brasil, MDMSc

CONTACT

+5511981210990; sbrasil@usp.br

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sergio Brasil

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 8, 2017
• Study Start: May 1, 2017
• Primary Completion: December 15, 2023
• Study Completion: December 31, 2023
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)