NCT02207296已完成3 期
Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery : a Multicentric Prospective Randomized Controlled Study
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- Length of hospital stay after knee or hip arthroplasty
研究概览
简要总结
The purpose of this study is to determine whether an operative hemodynamic optimization using the plethysmographic variability index during orthopedic surgery could decrease the length of hospital stay and the postoperative morbidity.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Indication to a knee or hip arthroplasty under general anesthesia
- •Sinusal rhythm
- •Non Inclusion Criteria:
- •Pregnant women
- •Black skin
- •Cardiac arrythmia
- •Use of another hemodynamic monitoring during surgery
排除标准
- 未提供
研究组 & 干预措施
PVI group
Other
Fluid optimisation using PVI
干预措施: Plethysmographic variability index (Device)
Control group
No Intervention
Standard care using a hemodynamic protocol during general anesthesia
结局指标
主要结局
Length of hospital stay after knee or hip arthroplasty
时间窗: Real length of hospital stay expressed as number of day (maximum 60 days)
Surgeons, blinded to the group allocation, are the postoperative care providers who decide the length of hospital stay.
次要结局
- Creatinine value(Postoperative Day 1 and Day 3)
- Postoperative cardiac complications(Participants will be followed for the duration of hospital stay, an expected average of 1 week, until postoperative day 60)
- Troponin value(Postoperative Day 1 and Day 3)
- Arterial Lactate(1 hour after end of surgery)
- Theorical length of hospital stay after knee or hip arthroplasty(Theorical length of hospital stay expressed as number of day (maximum 60 days))
研究者
研究点 (2)
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