Effects of Different Oxygen Concentrations on Pulmonary Complications in Patients Undergoing Radical Resection of Esophageal Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- the occurrence of atelectasis
研究概览
简要总结
Radical operation of esophageal cancer is complicated and traumatic, and ventilation with one lung in lateral position and ventilation with both lungs after supine position requires long-term tracheal intubation and ventilator-assisted ventilation, and the incidence of postoperative pulmonary complications is high.
详细描述
Therefore, we should explore the most appropriate lung protection ventilation strategy to reduce the occurrence of pulmonary complications. The recommended standard of international expert group on lung protective ventilation strategy points out that the lowest concentration of oxygen (≤40%) should be inhaled as much as possible during mechanical ventilation to maintain normal blood oxygen level (SpO2≥94%). If the mixed gas with low inhaled oxygen concentration can achieve ideal oxygen saturation and arterial oxygen partial pressure, it may reduce the postoperative pulmonary complications of the subjects. However, there are few reports on the influence of different oxygen concentrations on pulmonary complications in patients undergoing radical resection of esophageal cancer. This study intends to explore the influence of different oxygen concentrations on pulmonary complications in patients undergoing radical resection of esophageal cancer.
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
- Triple (Participant, Investigator, 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
- •American Association of Anesthesiologists (ASA) patients with I-II physical condition;
- •Patients with preoperative partial pressure of blood gas and oxygen greater than 80mmHg who were scheduled for elective esophageal cancer surgery were operated in the right lateral position first and then in the supine position.
排除标准
- •there is a history of acute lung injury with acute respiratory distress syndrome within three months;
- •Heart failure (classified by new york Heart Association) is greater than grade IV,
- •there is a serious liver and kidney dysfunction (children with grade B or C liver failure, glomerular filtration rate < 30 ml/min);
- •Body mass index > 30kg/m2；
- •coagulation dysfunction;
- •Operation time exceeds 10h
- •The amount of bleeding is more than 800ml, and the total fluid volume is more than 3000ml.
研究组 & 干预措施
Experimental: 30% Oxygen
Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 minuets. After successful anesthesia induction, FiO2 will be adjusted to 60% in one lung ventilation and 30% FIO2 in both lungs ventilation, and the total gas flow rate will be set at 2L/min. All patients will be performed via the lung protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cm H2O, RR: 1:2. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation, however when intraoperative oxygen saturation is less than 92% the manual lung recruitment maneuver will be done too. Arterial blood will be collected for blood gas analysis. Patients in both groups will be extubation the operating room and then sent to the PACU. patients should transfer to 60% Oxygen group if intraoperative oxygen saturation less than 85%.
干预措施: 30%Oxygen (Drug)
Experimental: 60% Oxygen
Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 minutes. After successful anesthesia induction, FiO2 will be adjusted to 100% in one lung ventilation and 60% FIO2 in both lungs ventilation, and the total gas flow rate will be set at 2L/min. All patients will be performed via the lung protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cm H2O, RR: 1:2. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation, however when intraoperative oxygen saturation is less than 92% the manual lung recruitment maneuver will be done too. Arterial blood will be collected for blood gas analysis. Patients in both groups will be extubation the operating room and then sent to the PACU.
干预措施: 60%Oxygen (Drug)
结局指标
主要结局
the occurrence of atelectasis
时间窗: On the operating room within 40 minutes after awakening
The primary outcome is the occurrence of atelectasis scanned by computerized tomography in the operating room within 40 minutes after awakening
次要结局
- oxygenation index(On the operating room within 40 minutes after awakening)
研究者
Wenfei Tan
Professor
China Medical University, China