Near-Infrared Spectroscopy Comparison Study

Nonin Medical

Status: Completed

Conditions: Total Aortic Arch Replacement

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01352260

H-27855

Details and patient eligibility

About

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

Enrollment: 17 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

17 participants in 1 patient group

Cardiac Disease

Description:

Total Aortic Arch Replacement