Role of Cerebral Oximetry In Reducing Delirium After Complex Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of patients who suffer from delirium postoperatively
研究概览
简要总结
Delirium after cardiac surgery is reported in a range of 3-47% of patients. Delirium is a serious complication that results in prolonged length of stay, increased health care costs and is associated with higher death rates. The exact cause involved in the development of delirium after cardiac surgery is unclear. The latest advancement in near-infrared spectroscopy (NIRS) Oximetry offers real-time management of patients at risk of brain injury. This approved device will monitor cerebral oxygenation during and 24hr after cardiac surgery, recording oxygenation in real time allowing the clinical team the opportunity to intervene early to prevent ischemia and possibly preventing untoward events. Adverse events followed include, but are not limited to, stroke, (transient ischemic attacks), heart attack, (myocardial infarction), clots found in lungs (pulmonary embolism), kidney failure, pneumonia, cause of death for 30-days after surgery (all cause mortality).
Hypothesis: Perioperative restoration of rSO2 desaturation to baseline values results in lower delirium rates after complex cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 60 years
- •combined valve and CABG
- •repeat cardiac surgery
- •multiple valve replacement or repair
- •surgery of ascending aorta and aortic arch
- •signed informed consent.
排除标准
- •cardiac surgery without the use of cardiopulmonary bypass
- •symptomatic cerebrovascular disease,
- •history of delirium, or
- •schizophrenia
研究组 & 干预措施
Near-infrared reflectance spectroscopy
Bilateral NIRS (The INVOS® Cerebral/Somatic Oximeter)will be used to measure rSO2 intraoperatively and during the 24h postoperative period in the intensive care unit. In the intervention group, an alarm threshold at 75% of the baseline rSO2 value will be established.
干预措施: Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) (Device)
Near-infrared reflectance spectroscopy
Bilateral NIRS (The INVOS® Cerebral/Somatic Oximeter)will be used to measure rSO2 intraoperatively and during the 24h postoperative period in the intensive care unit. In the intervention group, an alarm threshold at 75% of the baseline rSO2 value will be established.
干预措施: An alarm threshold at 75% of the baseline rSO2 value (Other)
Blinded Near-infrared reflectance spectroscopy
In the control group, the NIRS monitor screen will be electronically blinded, however, the recording will be continuous after verification of the signal strength and baseline value by an independent observer trained in NIRS application and unaware of the study design.
结局指标
主要结局
Number of patients who suffer from delirium postoperatively
时间窗: Delirium we be assessed postoperatively for 7 days or Discharge
Delirium assessment CAM-ICU preoperatively (baseline) and postoperatively once a day during the first 7 postoperative days or until discharge.
次要结局
未报告次要终点