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

NCT01289470 | Completed

• 1 other identifier: QATP1881
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery

Keywords

NIRS Technology; Cardiovascular surgery; valvular surgery with cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• Percent of time Regional Oxygen Saturation (rSO2) values are registered during open heart surgery.

  Completion of cardiovascular surgery

Secondary Outcomes (1)

• Correlation between delirium outcome scale and Regional Oxygen Saturation (rSO2) values.

  Patient discharge (on average 7 days)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nonin Medical, Inc: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• Solomon Aronson, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: February 3, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 21, 2012

Record last verified: 2012-05

Locations

US (1)