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

The Washington University

Status: Terminated

Conditions: Carotid Endarterectomy

Study type: Observational

Funder types: Other

Identifiers

NCT02102386

201312041

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

13 participants in 1 patient group

CerOx

Description:

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