Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery : A Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Incidence of patients presenting at least one complication after colorectal surgery
研究概览
简要总结
The purpose of this study is to determine whether hemodynamic optimization with photoplethysmography (ClearSight, Edwards Lifesciences, Irvine, CA) during colorectal surgery could decrease the incidence of perioperative complications.
详细描述
All patients received the photoplethysmography monitoring, but the monitor was blinded in the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age> 18 years
- •Colorectal surgery
排除标准
- •Pregnant women
- •Black skin
- •Chronic renal insufficiency (MDRD <30 ml/min)
研究组 & 干预措施
Control group
Control group using a hemodynamic standard protocol
Photoplethysmography group
Hemodynamic optimization using Photoplethysmography device (ClearSight, Edwards Lifesciences, Irvine, CA)
干预措施: Photoplethysmography (Device)
结局指标
主要结局
Incidence of patients presenting at least one complication after colorectal surgery
时间窗: Up to 28 days after surgery (length of hospital stay)
Two independent experts defined the presence of complication using an a priori classification.
次要结局
- Perioperative mortality(28 days after surgery)
- Real length of hospital stay(Up to 28 days after surgery (length of hospital stay))
- All complications happening after colorectal surgery(Up to 28 days after surgery (length of hospital stay))