Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries

Stopped early

Conditions studied: Carotid Endarterectomy

In brief

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

Key facts

Study ID

NCT02102386

Run by

Washington University School of Medicine

People needed

13

Starts

2014-02-01

Expected to finish

2015-01-01

Last updated by the study team

2015-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be considered eligible to participate in this study, a patient must meet the inclusion criteria listed below:
• Consenting patients over 18 years, undergoing elective carotid endarterectomy at Barnes Jewish Hospital.

You may not qualify if…

• 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

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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