Supplemental Oxygen and Surgical-site Infections: An Alternating Intervention Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,749
- 试验地点
- 1
- 主要终点
- Number of Participants With One or More Composite Complications
研究概览
简要总结
Our primary objective is to develop a clinical pathway for care of patients having colorectal surgery at the Clinic. In particular, the investigators would like to determine what intraoperative concentration of oxygen is optimal in our patients.
详细描述
The investigators therefore propose to test the primary hypothesis that supplemental oxygen (80% versus 30%) reduces the risk of a composite of surgical sites infection and potentially oxygen-related wound complications. Secondarily, the investigators will assess the incremental cost benefit of 80% versus 30% oxygen. As a safety measure, enough oxygen will always be given to maintain oxygen saturation (as determined by pulse oximetry) ≥95%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult colorectal surgical patients
排除标准
- 未提供
研究组 & 干预措施
30% oxygen
Inspired oxygen will be maintained at 30%.
干预措施: 30% oxygen (Drug)
80% oxygen
Inspired oxygen will be maintained at 80%.
干预措施: 80% oxygen (Drug)
结局指标
主要结局
Number of Participants With One or More Composite Complications
时间窗: Postoperative 30 days
A composite of complications: 1. surgical sites infection (organ space / deep) 2. Anastomotic leak 3. Intra-abdominal abscess 4. Sepsis 5. Wound dehiscence 6. Death
次要结局
- Number of Participants With Superficial SSI (Surgical Site Infection)(Postoperative 30 days)
研究者
Andrea Kurz
Principal Investigator
The Cleveland Clinic