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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nonin Medical, Inc
ClinicalTrials.gov Identifier:
NCT01289470
First received: January 14, 2011
Last updated: May 18, 2012
Last verified: May 2012
History of Changes

January 14, 2011
May 18, 2012
January 2011
March 2012   (final data collection date for primary outcome measure)
Percent of time Regional Oxygen Saturation (rSO2) values are registered during open heart surgery. [ Time Frame: Completion of cardiovascular surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01289470 on ClinicalTrials.gov Archive Site
Correlation between delirium outcome scale and Regional Oxygen Saturation (rSO2) values. [ Time Frame: Patient discharge (on average 7 days) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery
Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery

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.

See Eligibility Criteria section
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients undergoing Coronary Artery Bypass Graft (CABG) and valvular surgery with cardiopulmonary bypass
Heart; Dysfunction Postoperative, Cardiac Surgery
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01289470
QATP1881
No
Nonin Medical, Inc
Nonin Medical, Inc
Not Provided
Principal Investigator: Solomon Aronson, MD Duke University Health System
Nonin Medical, Inc
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP