Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries

NCT ID: NCT02102386

Last Updated: 2015-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Carotid Endarterectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CerOx

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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kangrga

Clinical Chief Director, Abdominal Organ Transplant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ivan Kangrga, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington Univesity School of Medicine

Andrea Vannucci, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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201312041

Identifier Type: -

Identifier Source: org_study_id

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