PeRioperative OXygen Fraction - Effect on Surgical Site Infection and Pulmonary Complications After Abdominal Surgery (The PROXI-trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,400
- 试验地点
- 14
- 主要终点
- Surgical wound infection
研究概览
简要总结
Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on surgical wound infection and pulmonary complications after abdominal surgery.
Background: Surgical wound infection is a common and serious complication. Tissue oxygen tension is often low after surgery and the resistance against infection depends on this factor through bacterial killing by neutrophils. Oxygen is a substrate in this reaction, and it is hypothesized that by increasing the arterial oxygen tension, the risk of surgical wound infection is reduced. Previous studies to test this hypothesis have shown entirely different results. Hence, the clinical decision between high and normal oxygen concentration is still controversial.
Primary hypothesis of study: Use of 80% oxygen decreases the incidence of surgical wound infection after abdominal surgery.
Secondary objectives: To investigate the effect 80% oxygen on pulmonary complications (atelectasis, pneumonia, respiratory insufficiency), second operation, mortality and length of postoperative hospitalization and admission to intensive care unit after abdominal 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
- Triple (Participant, Investigator, 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 or older.
- •Laparotomy, acute or elective. In case of gynaecological surgery only if malignancy is suspected (defined as risk of ovarian malignancy index >200 or a specimen with atypical or neoplastic cells).
排除标准
- •Other surgery within 30 days (except surgery in local anaesthesia).
- •Chemotherapy within 3 months.
- •Inability to give informed consent.
- •Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry).
研究组 & 干预措施
A
Fraction of inspired oxygen (FiO2) = 0.30
干预措施: Oxygen (Drug)
B
FiO2 = 0.80
干预措施: Oxygen (Drug)
结局指标
主要结局
Surgical wound infection
时间窗: 14 days after surgery
次要结局
- Atelectasis, pneumonia, respiratory insufficiency, second operation, mortality, length of postoperative hospitalization, admission to intensive care unit.(30 days after surgery)