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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01289470
Recruitment Status : Completed
First Posted : February 3, 2011
Last Update Posted : May 21, 2012
Information provided by (Responsible Party):
Nonin Medical, Inc

Brief 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.

Condition or disease
Heart; Dysfunction Postoperative, Cardiac Surgery

Detailed Description:
See Eligibility Criteria section

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery
Study Start Date : January 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Primary Outcome Measures :
  1. Percent of time Regional Oxygen Saturation (rSO2) values are registered during open heart surgery. [ Time Frame: Completion of cardiovascular surgery ]

Secondary Outcome Measures :
  1. Correlation between delirium outcome scale and Regional Oxygen Saturation (rSO2) values. [ Time Frame: Patient discharge (on average 7 days) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing Coronary Artery Bypass Graft (CABG) and valvular surgery with cardiopulmonary bypass

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01289470

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Nonin Medical, Inc
Principal Investigator: Solomon Aronson, MD Duke University Health System

Responsible Party: Nonin Medical, Inc Identifier: NCT01289470     History of Changes
Other Study ID Numbers: QATP1881
First Posted: February 3, 2011    Key Record Dates
Last Update Posted: May 21, 2012
Last Verified: May 2012

Keywords provided by Nonin Medical, Inc:
NIRS Technology
Cardiovascular surgery
valvular surgery with cardiopulmonary bypass