Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries

Carotid Endarterectomy Clinical Trial

— CerOx  

Official title:

Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02102386
• Other study ID #: 201312041
• Status: Terminated
• Phase: N/A
• First received: March 29, 2014
• Last updated: January 27, 2015
• Start date: February 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carotid Endarterectomy

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare cerebral perfusion and Oximetry changes to arterial blood pressure and trans-cranial doppler velocity changes	compare cerebral perfusion and Oximetry changes to arterial blood pressure and trans-cranial doppler velocity changes	up to 3 hours	No
Secondary	to compare cerebral perfusion and oximetry changes to non-invasive cardiac output, and systemic vascular resistances changes.	to compare cerebral perfusion and oximetry changes to non-invasive cardiac output, and systemic vascular resistances changes.	up to 3 hours	No