A Novel Non-invasive Technique of Cerebral Compliance and Auto-regulation Assessment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03144219|
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : September 30, 2022
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|
|Study Type :||Observational|
|Estimated Enrollment :||133 participants|
|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|
- 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.
- Impaired cerebral compliance [ Time Frame: 10 minutes ]Performing ICP and TCD monitoring simultaneously during jugular compression, matching waveform behavior through computer software QL Online
- 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
- Non-invasive intracranial compliance monitoring [ Time Frame: 10 minutes ]The same approaches described above, using the non-invasive Brain4Care system concomitantly.
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
|Contact: Sergio Brasil, MDMScemail@example.com|
|University of São Paulo||Recruiting|
|São Paulo, Brazil, 06630-060|
|Contact: Sergio Brasil 1136287231|