Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries

Terminated

• Conditions: Carotid Endarterectomy

• Registration Number: NCT02102386
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-29
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-02
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-27
• Last Update Posted: 2015-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
compare cerebral perfusion and Oximetry changes to arterial blood pressure and trans-cranial doppler velocity changes	up to 3 hours	compare cerebral perfusion and Oximetry changes to arterial blood pressure and trans-cranial doppler velocity changes

Secondary Outcome Measures

Name	Time	Method
to compare cerebral perfusion and oximetry changes to non-invasive cardiac output, and systemic vascular resistances changes.	up to 3 hours	to compare cerebral perfusion and oximetry changes to non-invasive cardiac output, and systemic vascular resistances changes.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States