NCT02198625Unknown4 期
Influence of Moderate Inspired Oxygen Fraction (FiO2) and Protective Ventilation on Postoperative Pulmonary Complication
Fenmei Shi1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2014年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- a composite of pulmonary and extrapulmonary complications occurring by day 7 after surgery.
研究概览
简要总结
The purpose of this study is to determine the influence of moderate FiO2 and the lung protective ventilation on postoperative pulmonary complications following hepatic resection surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 1~2,Planned intrabdominal hepatic resection surgery;
- •Expected duration 2 hours to 6 hours;
- •Age 40 yr to 70 yr);
- •BMI 18-26.9kg/m2
- •Risk of postoperative pulmonary complications (Arozullah score ≥2);
排除标准
- •Noninvasive ventilation in the last 30 days;
- •Recent history of pneumonia, ALI/ARDS (in the last 30 days);
- •History of pulmonary resection;
- •History of neuromuscular disease;
- •Child-Pugh>A grade；
- •Patient refusal;
结局指标
主要结局
a composite of pulmonary and extrapulmonary complications occurring by day 7 after surgery.
时间窗: during the first seven days after surgery
The primary outcome was a composite of major pulmonary complications (defined as pneumonia or need for invasive or noninvasive ventilation for acute respiratory failure) and extrapulmonary complications (defined as sepsis, septic shock, or death) within the first 7 days after surgery.
次要结局
- incidence of pulmonary complications(within the 30-day follow-up period)
- Oxidative stress markers(2 days)
研究者
Fenmei Shi
resident
First Affiliated Hospital, Sun Yat-Sen University
研究点 (1)
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