Continuous Invasive Versus 1-min Interval Oscillometric Arterial Pressure Monitoring and Hypotension During Induction of Anesthesia: a Bicenter, Randomized, Noninferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 2
- 主要终点
- MAP integral
研究概览
简要总结
Hypotension is common during surgery and about one-third of hypotension occur during the period from anesthesia induction to skin incision. Therefore, monitoring blood pressure during this period is crucial.
Two methods are used for measuring blood pressure during surgery: the intermittent measurement method (oscillometric method) and the continuous measurement method (arterial catheterization method). The latter is frequently used in surgical patients who require meticulous hemodynamic management, although there is no clearly defined indication for its use. Despite the benefits of arterial catheterization, it is often delayed after induction of general anesthesia, and blood pressure is monitored intermittently using the oscillometric method.
A recent study showed that continuous arterial pressure monitoring using arterial catheterization method during the induction of general anesthesia reduced hypotension significantly compared to 2.5-min interval intermittent arterial pressure monitoring using oscillometric method. The study was conducted on patients scheduled for continuous arterial pressure monitoring during surgery and the group with continuous arterial pressure monitoring showed significantly lower incidence of hypotension during the first 15 minutes of anesthesia induction.
However, measuring blood pressure using the oscillometric method at 1-min interval, rather than 2.5-min interval, may not be significantly inferior to continuous monitoring via arterial catheterization in terms of hypotension occurrence. This study aims to compare hypotension incidence between arterial catheterization method and oscillometric method with 1-min interval during induction of anesthesia in non-cardiac surgery patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 19 or older undergoing scheduled non-cardiac surgery with general anesthesia and continuous invasive arterial blood pressure monitoring via the radial artery
排除标准
- •Arterial access is clinically necessary before induction of anesthesia (e.g., moderate or higher degree of aortic stenosis, moderate or higher degree of heart failure, coronary artery disease requiring revascularization, intracranial aneurysm with a significant risk of rupture, etc.)
- •Emergency surgery
- •American Society of Anesthesiologists (ASA) physical status 5 or 6
- •Arterial access is required in a different artery other than the radial artery (e.g., the femoral artery)
- •Electrocardiogram other than sinus rhythm
- •Refusal to participate in the study
研究组 & 干预措施
1-min interval oscillometric method
1-min interval blood pressure monitoring using oscillometric method during induction of anesthesia
干预措施: 1-min interval oscillometric method (Device)
arterial catheterization method
Continuous blood pressure monitoring through arterial catheter during induction of anesthesia
干预措施: arterial catheterization method (Device)
结局指标
主要结局
MAP integral
时间窗: From the start of anesthesia induction to 15 minutes after
The area under the mean arterial pressure (MAP) of 65 mmHg calculated using the MAP recorded every second
次要结局
- Area under MAP of 60, 50, 40 mmHg (mmHg∙min)(From the start of anesthesia induction to 15 minutes after)
- Crystalloid (ml)(From the start of anesthesia induction to 15 minutes after)
- Duration of MAP <65, <60, <50, <40 mmHg (min)(From the start of anesthesia induction to 15 minutes after)
- Exposure to continuous MAP <65, <60, <50, <40 mmHg for 1 minute or longer (binary)(From the start of anesthesia induction to 15 minutes after)
- Area above MBP of 100, 110, 120, 140 mmHg (mmHg∙min)(From the start of anesthesia induction to 15 minutes after)
- Exposure to MAP <65, <60, <50, and <40 mmHg (binary)(From the start of anesthesia induction to 15 minutes after)
- MAP standard deviation (mmHg)(From the start of anesthesia induction to 15 minutes after)
- Use of vasopressor (dose)(From the start of anesthesia induction to 15 minutes after)
- Use of vasopressor (binary)(From the start of anesthesia induction to 15 minutes after)
研究者
Karam Nam, MD
Clinical Associate Professor
Seoul National University Hospital