Effect of Different Oxygen Concentration on Postoperative Pulmonary Complications After Pulmonary Reexpansion Following One-lung Ventilation in Thoracic Surgery（DOC-PCT Trial）- A Prospective Randomized Controlled Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The incidence of a composite of postoperative pulmonary complications (PPCs) within the first 7 postoperative days
研究概览
简要总结
To evaluate the effect of 80% inspiratory oxygen fraction (FiO2) and 30% FiO2 on the incidence of pulmonary complications after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative within the first 7 days after thoracic surgery, based on lung protective ventilation strategy.
详细描述
Postoperative pulmonary complications (PPCs) account for the highest proportion (about 84%) among all the factors leading to death in thoracic surgery. High FiO2 was used in perioperative period. However, there is increasing evidence that high FiO2 in non-thoracic surgery can increase respiratory related adverse events and even mortality. The guideline also suggests that low FiO2 (30-50%) during surgery while ensuring moderate level of oxygenation would be more beneficial to the prognosis of patients. Whereas, the selection of oxygen concentration in thoracic surgery is still unclear, especially which oxygen concentration ventilation is more beneficial to reduce PPCs after pulmonary reexpansion. Strict randomized controlled clinical studies are urgently needed to verify the differences in the incidence of PPCs in patients with different oxygen concentration ventilation strategies. The study aim is to evaluate the effect of 80% FiO2 and 30% FiO2 on the incidence of pulmonary complications after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative within the first 7 days after thoracic surgery, based on lung protective ventilation strategy, and to provide clinical basis for optimizing perioperative management of thoracic surgery and effectively reducing the occurrence of perioperative pulmonary complications
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective thoracic surgery: lung surgery, esophageal surgery, mediastinal surgery, etc.;
- •One-lung ventilation: double lumen bronchial cannula or occluder is used for isolation of one lung; 3, American Society of Anesthesiology (ASA) grade I ~ III; 4, 18 years ≤ age < 80 years;
- •Estimated operation time ≥2 hours;
- •Agree to participate and sign the informed consent.
排除标准
- •Severe lung infection occurs within 1 month;
- •Coronary heart disease or heart failure occurs within 2 or 3 months;
- •Preoperative oxygen saturation is less than 94%; 4, Need continuous oxygen therapy; 5, BMI>35 kg/m2;
- •Pregnant women;
- •Preoperative Hb<70g/L or haematocrit<30%.
研究组 & 干预措施
Received low FiO2
Patients undergoing elective thoracic surgery were treated with 30% FiO2 after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative.
干预措施: low FiO2 (Procedure)
Received high FiO2
Patients undergoing elective thoracic surgery were treated with 80% FiO2 after pulmonary reexpansion following one-lung ventilation and 2-hour postoperative.
干预措施: high FiO2 (Procedure)
结局指标
主要结局
The incidence of a composite of postoperative pulmonary complications (PPCs) within the first 7 postoperative days
时间窗: 7 postoperative days
The incidence of a composite of PPCs within the first 7 postoperative days evaluated by established criteria
次要结局
- Oxygenation index(after extubation and 1 day after surgery)
- Length of stay in ICU(immediately after surgery)
- PPCs related mortality(30 postoperative days)
- Secondary diagnosis of PPCs(7 postoperative days)
- Grading of PPCs(7 postoperative days)
- Grading of surgical complications(30 postoperative days)
- Extubation time(immediately after surgery)
- Duration of hospitalization(immediately after admission)
- Incidence of respiratory system related symptoms(30 postoperative days)
- All-cause mortality(30 postoperative days)