Near-Infrared Spectroscopy Comparison Study

Completed

Conditions studied: Total Aortic Arch Replacement

In brief

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

Key facts

Study ID

NCT01352260

Run by

Nonin Medical, Inc

People needed

17

Starts

2011-05-01

Expected to finish

2012-04-01

Last updated by the study team

2012-05-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 -

You may not qualify if…

• 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

Where it is running

• Baylor College of Medicine and affiliated Hospitals — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.