The Impact of Different Intraoperative Supplemental Oxygen Administration on the Pulmonary Function Following Minimally Invasive Esophagectomy: A Prospective Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The change of oxygenation index
研究概览
简要总结
The study hypothesized that a relative low oxygen concentration (40%) supplemental would be advantageous to protect the pulmonary function of patients, comparied with conventional high oxygen concentration (80%). Therefore we raise this prospective randomized controlled research.
详细描述
Patients underwent minimally invasive esophagectomy in Zhongshan Hospital of Fudan University will be enrolled and be randomizedly assigned to low oxygen concentration (40%) supplemental or high oxygen concentration(80%) supplemental group. Intra-operative and post-operative pressure of Oxygen in Arterial Blood will be examined, and the surgical outcome will be recorded in the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy.
- •Patients underwent minimally invasive esophagectomy(Thoracolaparoscopic McKeown procedure).
排除标准
- •Patients with previous thoracic surgery history.
- •Patients with severe Co-morbidity.
- •Pulmonary function is abnormal in the examination before surgery.
研究组 & 干预措施
low supplemental oxygen concentration
The group in which low supplemental oxygen concentration of 40% will be performed during minimally invasive esophagectomy.
干预措施: low supplemental oxygen concentration (Procedure)
high supplemental oxygen concentration (conventional)
The group in which high supplemental oxygen concentration (onventional) of 80% will be performed during minimally invasive esophagectomy.
干预措施: high supplemental oxygen concentration (conventional) (Procedure)
结局指标
主要结局
The change of oxygenation index
时间窗: Change from Baseline at post-operative Day1
The change of oxygenation index is an important index to indicate the pulmonary function of patients.
次要结局
未报告次要终点
研究者
Tan, Lijie
Professor of Surgery; Vice Chief, Division of Thoracic Surgery
Fudan University