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.

Study Overview

• Status: Completed
• Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery

Detailed Description

See Eligibility Criteria section

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent of time Regional Oxygen Saturation (rSO2) values are registered during open heart surgery.	Completion of cardiovascular surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation between delirium outcome scale and Regional Oxygen Saturation (rSO2) values.	Patient discharge (on average 7 days)

Collaborators and Investigators

• Sponsor: Nonin Medical, Inc
• Investigators: Principal Investigator: Solomon Aronson, MD, Duke Health

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: January 14, 2011
• First Submitted That Met QC Criteria: February 2, 2011
• First Posted (Estimate): February 3, 2011

Study Record Updates

• Last Update Posted (Estimate): May 21, 2012
• Last Update Submitted That Met QC Criteria: May 18, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Cardiovascular surgery; NIRS Technology; valvular surgery with cardiopulmonary bypass
• Other Study ID Numbers: QATP1881