Oscillometric Blood Pressure Measurement At 2.5- Vs. 5-minute Intervals and Hypotension in Patients Having Non-cardiac Surgery: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Time-weighted average mean arterial pressure <65 mmHg
研究概览
简要总结
This is a randomized trial investigating the effect of oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - on intraoperative hypotension. Specifically, the investigators will test the primary hypothesis that oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - reduces the time-weighted average mean arterial pressure below 65 mmHg in patients having non-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
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥45 years
- •scheduled for elective non-cardiac surgery under general anesthesia
- •planned oscillometric blood pressure monitoring with an upper-arm cuff
- •American Society of Anesthesiologists physical status class II or higher
排除标准
- •emergency surgery
- •arm or shoulder surgery
- •pregnancy
- •preoperative blood pressure differences between the right and left arm of more than 20 mmHg
- •intraoperative invasive blood pressure monitoring
- •previous preoperative peripheral nerve injury (such as diabetic neuropathy, carpal tunnel syndrome, or cervical radiculopathy)
- •contraindication for continuous finger-cuff blood pressure monitoring (e.g., Raynaud's disease, arterial-venous shunts, or cardiac assist devices)
研究组 & 干预措施
Oscillometric blood pressure monitoring at 2.5-minute intervals
In patients assigned to oscillometric blood pressure monitoring at 2.5-minute intervals, oscillometric upper-arm cuff blood pressure will be measured and displayed on the patient monitor every 2.5 minutes during surgery.
Blood pressure will additionally measured with BLINDED continuous non-invasive finger-cuff blood pressure monitoring.
干预措施: Oscillometric blood pressure monitoring at 2.5-minute intervals (Other)
Oscillometric blood pressure monitoring at 5-minute intervals
In patients assigned to oscillometric blood pressure monitoring at 5-minute intervals, oscillometric upper-arm cuff blood pressure will be measured and displayed on the patient monitor every 5 minutes during surgery.
Blood pressure will additionally measured with BLINDED continuous non-invasive finger-cuff blood pressure monitoring.
干预措施: Oscillometric blood pressure monitoring at 5-minute intervals (Other)
结局指标
主要结局
Time-weighted average mean arterial pressure <65 mmHg
时间窗: Beginning of surgery until the end of surgery
The primary endpoint will be the time-weighted average mean arterial pressure \<65 mmHg (continuous outcome) - defined as the area under a MAP of 65 mmHg divided by the time of continuous finger-cuff blood pressure monitoring \[mmHg\].
次要结局
- Episodes of a mean arterial pressure <50 mmHg(Beginning of surgery until the end of surgery)
- Norepinephrine dose(Beginning of surgery until the end of surgery)
研究者
Karim Kouz
Dr. Karim Kouz, Principal Investigator
University of Hamburg-Eppendorf