Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02102386

Acronym

CerOx

Enrollment

Registered

2014-04-02

Start date

2014-02-28

Completion date

2015-01-31

Last updated

2015-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Endarterectomy

Keywords

elective, carotid endarterectomy surgery

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results