Monitoring Brain Perfusion and Cerebral Oximetry in Carot... | NCT02102386

Studies
Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries

NCT02102386

Sponsor

Washington University School of Medicine

Status

Terminated

Last Update Posted

Jan 29, 2015Estimated

Enrollment

13Actual

Phase

Not provided

Conditions

Carotid Endarterectomy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Technical issues with the device under study. Sponsor terminated.

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Mar 29, 2014

First Submission Date that Met QC Criteria

Apr 1, 2014

First Posted Date

Apr 2, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2015

Last Update Posted Date

Jan 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Label	Type	Description	Intervention Names
CerOx		Patients will be monitored using the CerOx monitor. Probes will be attached bi-laterally in the OR to the forehead.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

Emergency surgery
National Institute of health Stroke Scale (NIHSS) score >=10
Sub-cutaneous hematoma at the ipsilateral intended area of the CerOx probe location.
Laceration or scalp injury at the ipsilateral intended area of the CerOx probe location which contraindicates placement of the adhesive on the skin.
Patient with implants located in the intended area of the CerOx probe location.
Prisoners
Non-consenting patient Or non-participating surgeon schedule of assessments and procedures
Pregnant or lactating women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ivan Kangrga, MD, PhD	Washington Univesity School of Medicine	Principal Investigator
Andrea Vannucci, MD	Washington University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States