Near-Infrared Spectroscopy Comparison Study
Completed
- Conditions
- Total Aortic Arch Replacement
- Registration Number
- NCT01352260
- Lead Sponsor
- Nonin Medical, Inc
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Linear correlation between absolute value of cerebral oxygen saturation (rSO2) compared to Jugular Venous Oxygen Saturation (SjvO2). Sensitivity and specificity to detect < 60% desaturation. At the end of the surgical case approximately 6 to 8 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Baylor College of Medicine and affiliated Hospitals
🇺🇸Houston, Texas, United States