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Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery

NCT01289470 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2012-05-21

No results posted yet for this study

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.

Conditions

  • Heart; Dysfunction Postoperative, Cardiac Surgery

Sponsors & Collaborators

  • Nonin Medical, Inc

    lead INDUSTRY

Principal Investigators

  • Solomon Aronson, MD · Duke Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01289470 on ClinicalTrials.gov