Intracranial Hypertension Clinical Trial
Official title:
A Novel Non-invasive Technique of Cerebral Compliance and Auto-regulation Assessment
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.
Status | Recruiting |
Enrollment | 133 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: Patients whose underwent ICP monitoring displaying both ICP curves and values. Exclusion Criteria: Patients whose display absence of insonation window |
Country | Name | City | State |
---|---|---|---|
Brazil | University of São Paulo | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo | Brain4Care USA Corp. |
Brazil,
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Dahlqvist MB, Andres RH, Raabe A, Jakob SM, Takala J, Dünser 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. — View Citation
Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247. Review. — View Citation
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. — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impaired cerebral compliance | Performing ICP and TCD monitoring simultaneously during jugular compression, matching waveform behavior through computer software QL Online | 10 minutes | |
Secondary | Impaired cerebral auto-regulation | The same procedure detailed above, matching mean arterial pressure and CBFv in the computer software QL Online | 10 minutes | |
Secondary | Non-invasive intracranial compliance monitoring | The same approaches described above, using the non-invasive Brain4Care system concomitantly. | 10 minutes |
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