Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries

NCT02102386 | Terminated

• 1 other identifier: 201312041
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

Carotid Endarterectomy

Keywords

elective; carotid endarterectomy surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• to compare cerebral perfusion and oximetry changes to non-invasive cardiac output, and systemic vascular resistances changes.

  up to 3 hours

Study Arms (1)

CerOx

Patients will be monitored using the CerOx monitor. Probes will be attached bi-laterally in the OR to the forehead.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo elective carotid endarterectomy at Barnes Jewish Hospital.

You may not qualify if:

• \. Consenting patients over 18 years, undergoing elective carotid endarterectomy at Barnes Jewish Hospital.
• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Study Officials

• Ivan Kangrga, MD, PhD

  Washington Univesity School of Medicine

  PRINCIPAL INVESTIGATOR

• Andrea Vannucci, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Chief Director, Abdominal Organ Transplant

Study Record Dates

• First Submitted: March 29, 2014
• First Posted: April 2, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 29, 2015

Record last verified: 2015-01

Locations

US (1)