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Clinical Trial Summary

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.


Clinical Trial Description

See Eligibility Criteria section ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Heart; Dysfunction Postoperative, Cardiac Surgery

NCT number NCT01289470
Study type Observational
Source Nonin Medical, Inc
Contact
Status Completed
Phase N/A
Start date January 2011
Completion date March 2012

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