Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,267
- 试验地点
- 1
- 主要终点
- Post operative myocardial injury
研究概览
简要总结
Continuous non-invasive arterial pressure monitoring has the potential to decrease the duration of intraoperative hypotension and hypertension compared to conventional intermittent blood pressure monitoring. Chen et al. demonstrated using continuous non-invasive arterial pressure devices for every hour of surgery it is possible to identify an average of 14 minutes of potentially treatable hypotensive and hypertensive time(12). Whether the ability to detect more hypotension events by continuous non-invasive arterial pressure monitoring use can improve patient outcomes, is still an open research question
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •All adult (age ≥18 years) patients scheduled for elective non-cardiac surgery in participating centers
- •Surgical case planned with non invasive blood pressure monitoring according to local clinical practice or policies.
排除标准
- •Missing of preoperative serum creatinine during 30 days prior surgery
- •Preoperative dialysis
- •Chronic kidney disease (eGFR < 60ml/min Cockcroft-Gault equation)
- •Surgical procedure lasting less than 60 min
- •Planned use of permissive hypotension
- •Urological procedures (including nephrectomy and renal transplantation)
- •Refusal to give informed consent
研究组 & 干预措施
cNIBP
Continuous non invasive blood pressure monitor (Volume clamp)
干预措施: Continuous Non Invasive Blood Pressure Monitoring (Device)
iNIBP
Intermittent Non Invasive Blood Pressure (Brachial Cuff)
干预措施: Intermittent Non Invasive Blood Pressure Monitoring (Device)
结局指标
主要结局
Post operative myocardial injury
时间窗: 1 week
The primary outcome will be the proportions of myocardial injury (Definitions: elevation of serum Troponin T (TnT) \>= 30 ng/L in the first post-operative week)
次要结局
- Post operative death(28 day after surgery)
- Events 30d post surgery(30 days after surgery)
- Events 90d post surgery(90 days after surgery)
- Post operative Acute kidney injury(1 week)
研究者
Alberto Noto
Prof.
University of Messina