Near-Infrared Spectroscopy Comparison Study

N

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

  • 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

Trial design

17 participants in 1 patient group

Cardiac Disease
Description:
Total Aortic Arch Replacement

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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