Validation of Near-Infrared Spectroscopy for Neuromonitoring During Moderate Hypothermic Circulatory Arrest for Total Aortic Arch Replacement: A Comparison of Two Technologies With Jugular Venous Bulb Oximetry

Nonin Medical, Inc1 site in 1 country17 target enrollmentMay 2011

ConditionsTotal Aortic Arch Replacement

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Total Aortic Arch Replacement
Sponsor: Nonin Medical, Inc
Enrollment: 17
Locations: 1
Primary Endpoint: Linear correlation between absolute value of cerebral oxygen saturation (rSO2) compared to Jugular Venous Oxygen Saturation (SjvO2). Sensitivity and specificity to detect < 60% desaturation.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to validate Near-Infrared (NIRS) monitoring in patients undergoing circulatory arrest. This study will compare two-wavelength NIRS INVOS System, Somanetics; Troy, MI) with four-wavelength NIRS (Nonin Medical, Inc; Plymouth, MN) to determine which modality best correlates with jugular venous oxygen saturation

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

April 2012

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Nonin Medical, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provide written informed consent from patient or legally authorized representative before surgery
•Adult patients 18-65 years of age
•Presenting for elective or urgent total aortic arch repair under moderate hypothermic circulatory arrest (Nasopharyngeal temperature 20 - 24 ºC) with selective antegrade cerebral perfusion -

Exclusion Criteria

•Patients will be excluded from this study if they are age less than 18
•Are undergoing an emergent procedure
•Have a history of insulin-dependent diabetes mellitus
•Have a history of stroke
•Are undergoing a redo sternotomy during which major bleeding occurs necessitating transfusion of \> 4 units of packed red blood cells prior to the institution of circulatory arrest
•Patients in whom a left jugular venous bulb cannula cannot successfully be placed

Outcomes

Primary Outcomes

Linear correlation between absolute value of cerebral oxygen saturation (rSO2) compared to Jugular Venous Oxygen Saturation (SjvO2). Sensitivity and specificity to detect < 60% desaturation.

Time Frame: At the end of the surgical case approximately 6 to 8 hours