跳至主要内容
临床试验/NCT04008420
NCT04008420Unknown不适用

The Association of Intraoperative Oxygen Reserve Index and Postoperative Pulmonary Complications in Robot-assisted Esophagectomy

Yonsei University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年7月31日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
The value of oxygen reserve index during anesthesia

研究概览

简要总结

The World Health Organization (WHO) has proposed the use of 80% high-dose inhalation oxygen (FiO2) during surgery to reduce postoperative infection in adult patients undergoing general anesthesia. However, high-dose inhaled oxygen increases the risk of oxygen toxicity by increasing reactive oxygen species, and according to a recent research, hyperoxia in the ICU is one of the causes of mortality. In patients with general anesthesia requiring intubation, high-dose inhaled oxygen was associated with postoperative pulmonary complications in a dose-proportional manner and was significantly associated with mortality within 30 days after surgery. Therefore, it is necessary to study the optimum oxygen concentration during surgery to reduce postoperative pulmonary complications in general anesthesia patients who require intubation. Esophagectomy for esophageal cancer still has higher morbidity and mortality rates than other common procedures. There are several factors such as aneurysmal leakage, esophageal substitute necrosis, cardiac complications, and pulmonary complications. Pulmonary complications have been reported to be a very important factor. Therefore, various methods have been proposed to reduce pulmonary complications after esophageal cancer surgery. One of them is minimally invasive surgery. However, even in the case of a thoracoscopic operation using a robot, one lung ventilation is inevitable for securing the visual field during surgery, and hypoxia and hyperoxia are known to be associated with postoperative acute lung injury. Therefore, in order to reduce postoperative pulmonary complications in the esophagectomy using robots, it is necessary to study the optimum oxygen concentration during surgery. The recently developed oxygen reserve index (ORI) uses a non-invasive sensor attached to the finger, similar to pulse oximetry, to detect persistent hyperoxia of more than 100 mmHg and less than 200 mmHg. Therefore, if the oxygen reserve index is used for robotic esophagectomy, which requires one lung ventilation, the degree of oxygenation of the patient can be monitored continuously and accurately. The authors will measure the oxygen reserve index in robotic esophagectomy, and analyze the correlation between oxygen reserve index and postoperative pulmonary complications. Furthermore, the cut-off value of the oxygen reserve index, which can reduce pulmonary complications, will be calculated.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults who are scheduled to undergo robotic esophagectomy

排除标准

  • Patients under 20 years old
  • Patients who can not read the consent form or are not fluent in Korean
  • Patients who refused the clinical trial
  • Patients admitted to the intensive care unit with endotracheal tube

结局指标

主要结局

The value of oxygen reserve index during anesthesia

时间窗: Participants will followed until discharge (within about 2 months after surgery).

The investigators will monitor the oxygen reserve index during anesthesia.

次要结局

  • Postoperative pulmonary complications(Participants will followed until discharge (within about 2 months after surgery).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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