Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery
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An observational study designed to evaluate the performance of a new Near Infrared Spectroscopy (NIRS) tissue oximeter device in the clinical setting, including a cerebral sensor and peripheral sensor. Fifty patients who are undergoing open-heart surgery will be enrolled and tissue oximetry measurement will be collected throughout the surgical procedure and for up to 24 hours following surgery. Tissue oximeter measurement of the brain and skeletal tissue will be added to the standard intra-operative patient monitoring. Measures of delirium will be collected using a standardized questionnaire. The relationship between cerebral oximetry measures and delirium scores will be explored.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients undergoing Coronary Artery Bypass Graft (CABG) and valvular surgery with cardiopulmonary bypass
Age 18 years or older
Weigh at least 40 kg
Undergoing Coronary Artery Bypass Graft (CABG) and/or valvular surgery requiring the use of Cardio Pulmonary Bypass (CPB) or Left Ventricular Assist Device (LVAD), inclusive of any concomitant procedure
Willing and able to provide informed consent
Able to communicate and read in English
Emergency procedure such that informed consent may not be obtained
Known cognitive impairment, history of delirium or dementia
Known hemodialysis or fistula graft
Delirium Observation Score (DOS) Score of >6 prior to surgery
Pre-existing skin condition at the site of sensor application (e.g. eczema, dermatitis)
Any known contraindication or sensitivity to the cerebral oximeter sensor