The Relationship Between Administered Oxygen Levels and Arterial Partial Oxygen Pressure to Neurocognition in Post-operative Mechanically Ventilated Cardiac Surgical Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Telephonic-MoCA (t-MoCA)
研究概览
简要总结
This is a randomized, prospective controlled trial in patients undergoing cardiac surgery, specifically on-pump coronary artery bypass grafting, comparing level of administered oxygen and partial pressure of arterial oxygen in the operating room and its impact on a widely-used and validated neurocognitive score, the telephonic Montreal Cognitive Assessment (t-MoCA), throughout the hospital stay and at 1 month, 3 months, and 6 postoperatively. It is hypothesized that cardiac surgical patients who undergo normoxic conditions throughout the intraoperative period will have better neurocognitive function than those with maintenance of hyperoxia.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 65 years and older
- •Undergoing elective or urgent on-pump Coronary Artery Bypass Graft (CABG) only
排除标准
- •Off-pump or any other procedure in addition to CABG
- •Emergent procedure
- •One-lung ventilation
- •Non-English speaking
- •Baseline tMoCA score <10
- •Preoperative inotrope use
- •Preoperative vasopressor use
- •Intra-aortic balloon counterpulsation
- •Mechanical circulatory support (Intra-aortic balloon pump (IABP)/ Ventricular assisted devices (VAD)/Extracorporeal membrane oxygenation (ECMO))
- •Active cardiac ischemia
- •Acute decompensated arrhythmia
- •O2 sat < 90% on supplemental oxygen
- •Use of continuous vasopressor or inotrope infusion medications
- •Significant physician or nurse concern
- •Cessation Criteria
- •Development of significant intraoperative hemodynamic compromise as a result of cardiac surgery
- •Oxygen desaturation <90% for > 3 min
- •Significant physician or nurse concern
结局指标
主要结局
Telephonic-MoCA (t-MoCA)
时间窗: Change from baseline tMoCA score through 6 months
t-MoCA will be performed baseline, daily starting POD#1 as well as at 1, 3 and 6 months post-operatively. In previous studies, testing through month 6, has been shown to accurately reflect more longitudinal follow-up. t-MoCA results are on a 22 point scale and will be used as a marker for cognitive function and has been validated. Blinded study staff trained in administering the assessments will collect the data.
次要结局
- Days of mechanical ventilation(Post-operative day 1 through discharge from hospital (3-5 days on average))
- Confusion Assessment Method for the ICU(Post-operative day 1 through discharge from hospital (3-5 days on average))
- Length of stay in hospital(Post-operative day 1 through discharge from hospital (3-5 days on average))
- Patient mortality(30 days and 6 months post-operatively)
- Time to extubation(Post-operative day 1 through discharge from hospital)
- Biomarkers of oxidative stress, IL-6, IL-8 and others(Intraoperatively at cardiopulmonary bypass (CPB))
研究者
Shahzad Shaefi
Anesthesiologist
Beth Israel Deaconess Medical Center