Near-Infrared Spectroscopy Comparison Study

Nonin Medical, Inc17 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Total Aortic Arch Replacement

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Provide written informed consent from patient or legally authorized representative before surgery 2. Adult patients 18-65 years of age 3. 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: 1. Patients will be excluded from this study if they are age less than 18 2. Are undergoing an emergent procedure 3. Have a history of insulin-dependent diabetes mellitus 4. Have a history of stroke 5. 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 6. Patients in whom a left jugular venous bulb cannula cannot successfully be placed

Locations (1)

Baylor College of Medicine and affiliated Hospitals

Houston, Texas, United States

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

Data from ClinicalTrials.gov

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