Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries (CerOx)

January 27, 2015 updated by: kangrga, Washington University School of Medicine

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

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

  1. Emergency surgery
  2. National Institute of health Stroke Scale (NIHSS) score >=10
  3. Sub-cutaneous hematoma at the ipsilateral intended area of the CerOx probe location.
  4. Laceration or scalp injury at the ipsilateral intended area of the CerOx probe location which contraindicates placement of the adhesive on the skin.
  5. Patient with implants located in the intended area of the CerOx probe location.
  6. Prisoners
  7. Non-consenting patient Or non-participating surgeon schedule of assessments and procedures
  8. Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CerOx
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?

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Ivan Kangrga, MD, PhD, Washington Univesity School of Medicine
  • Principal Investigator: Andrea Vannucci, MD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

March 29, 2014

First Submitted That Met QC Criteria

April 1, 2014

First Posted (Estimate)

April 2, 2014

Study Record Updates

Last Update Posted (Estimate)

January 29, 2015

Last Update Submitted That Met QC Criteria

January 27, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201312041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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