Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery
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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 |
- 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 ]
- 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) |
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 |
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
Contacts and Locations| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| 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 May 23, 2013