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
  Purpose

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
Heart; Dysfunction Postoperative, Cardiac Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery

Resource links provided by NLM:


Further study details as provided by Nonin Medical, Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Correlation between delirium outcome scale and Regional Oxygen Saturation (rSO2) values. [ Time Frame: Patient discharge (on average 7 days) ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Detailed Description:

See Eligibility Criteria section

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing Coronary Artery Bypass Graft (CABG) and valvular surgery with cardiopulmonary bypass

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289470

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

No publications provided

Responsible Party: Nonin Medical, Inc
ClinicalTrials.gov Identifier: NCT01289470     History of Changes
Other Study ID Numbers: QATP1881
Study First Received: January 14, 2011
Last Updated: May 18, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 29, 2014