Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries

Study Overview
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Brief Summary
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The goal of this study is to demonstrate Or-Nim's CerOx monitor ability to monitor changes in cerebral blood flow and oximetry during CEA surgery. Procedures include: Screening: ECG, blood draw, neurological assessment, NIHSS study: CerOX and TCD clock during CEA procedure, data collection from the medical record/monitors, neurological assessment, NIHSS 30 day follow-up

Official Title
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Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries

Conditions
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Carotid Endarterectomy

Participation Criteria
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Eligibility Criteria
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Patients scheduled to undergo a CEA procedure that have consented to participate in the study will be included in this observational study. Research Subjects: Indications for monitoring include patients scheduled for CEA that comply with the inclusion and exclusion criteria. Inclusion Criteria To be considered eligible to participate in this study, a patient must meet the inclusion criteria listed below: 1. Consenting patients over 18 years, undergoing elective carotid endarterectomy at Barnes Jewish Hospital. Exclusion Criteria To be eligible for entry into the study, the patient must not meet any of the exclusion criteria listed below: Emergency surgery National Institute of health Stroke Scale (NIHSS) score >=10 Sub-cutaneous hematoma at the ipsilateral intended area of the CerOx probe location. Laceration or scalp injury at the ipsilateral intended area of the CerOx probe location which contraindicates placement of the adhesive on the skin. Patient with implants located in the intended area of the CerOx probe location. Prisoners Non-consenting patient Or non-participating surgeon schedule of assessments and procedures Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CerOx<br>Patients will be monitored using the CerOx monitor. Probes will be attached bi-laterally in the OR to the forehead. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare cerebral perfusion and Oximetry changes to arterial blood pressure and trans-cranial doppler velocity changes | compare cerebral perfusion and Oximetry changes to arterial blood pressure and trans-cranial doppler velocity changes | up to 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to compare cerebral perfusion and oximetry changes to non-invasive cardiac output, and systemic vascular resistances changes. | to compare cerebral perfusion and oximetry changes to non-invasive cardiac output, and systemic vascular resistances changes. | up to 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elective, carotid endarterectomy surgery