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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
kangrga, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02102386
First received: March 29, 2014
Last updated: April 1, 2014
Last verified: March 2014
  Purpose

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


Condition
Carotid Endarterectomy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • compare cerebral perfusion and Oximetry changes to arterial blood pressure and trans-cranial doppler velocity changes [ Time Frame: up to 3 hours ] [ Designated as safety issue: No ]
    compare cerebral perfusion and Oximetry changes to arterial blood pressure and trans-cranial doppler velocity changes


Secondary Outcome Measures:
  • to compare cerebral perfusion and oximetry changes to non-invasive cardiac output, and systemic vascular resistances changes. [ Time Frame: up to 3 hours ] [ Designated as safety issue: No ]
    to compare cerebral perfusion and oximetry changes to non-invasive cardiac output, and systemic vascular resistances changes.


Estimated Enrollment: 50
Study Start Date: February 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
CerOx
Patients will be monitored using the CerOx monitor. Probes will be attached bi-laterally in the OR to the forehead.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02102386

Contacts
Contact: Jennifer Parchomski, RN 314-747-5164 parchomj@anest.wustl.edu
Contact: Jane Blood, RN 314-747-5531 bloodj@anest.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Ivan Kangrga, MD, PhD         
Sub-Investigator: Andrea Vannucci, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: kangrga, Clinical Chief Director, Abdominal Organ Transplant, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02102386     History of Changes
Other Study ID Numbers: 201312041
Study First Received: March 29, 2014
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
elective
carotid endarterectomy surgery

ClinicalTrials.gov processed this record on October 23, 2014