Clinical Assessment of Nonin 7600 Near Infrared Spectroscopy (NIRS) Tissue Oximetry During Cardiovascular Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percent of time Regional Oxygen Saturation (rSO2) values are registered during open heart surgery.
研究概览
简要总结
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.
详细描述
See Eligibility Criteria section
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percent of time Regional Oxygen Saturation (rSO2) values are registered during open heart surgery.
时间窗: Completion of cardiovascular surgery
次要结局
- Correlation between delirium outcome scale and Regional Oxygen Saturation (rSO2) values.(Patient discharge (on average 7 days))