Efficacy of Nebulized Pulmicort Respules on Post Operation Pulmonary Complication During Pulmonary Single Lobectomy Surgery in Primary Lung Cancer Patients With COPD
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 73
- 主要终点
- The incidence of post-operation pulmonary complication in two arms among primary lung cancer patients with COPD
研究概览
简要总结
To test the hypothesis that nebulized Pulmicort Respules could reduce post operation pulmonary complication incidence in primary lung cancer patients with COPD. Compare post-operation pulmonary complication incidence in two treatment arms among primary lung cancer patients with COPD required single lobectomy from 3days before operation to 7 days after operation.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed or existing COPD defined by GOLD, and FEV1 of<80% predicted and FEV1/FVC<70%
- •Diagnosed as primary lung cancer by China guidelines on diagnosis and treatment of primary lung cancer
- •.Consistent with indication of operation of pulmonary single lobectomy surgery by China guidelines on diagnosis and treatment of primary lung cancer
- •General anesthesia and double cavity intubation was used during operation
- •ASA Classification of Anesthesia Risk is in category 1-3 both in baseline
- •age from 40-80 years old
- •Smoking cessation more than two weeks before operation
- •SP O2>90% before surgery
- •Hemoglobin > 10g/dl
- •Estimated duration of surgery < 4 hours
- •18.5<BMI < 28
排除标准
- •Patients who had taken systemic corticosteroids in the preceding 1month before baseline
- •Patients who had pneumonia in the preceding 1month before baseline
- •Patients with a history of recent myocardial infarction, heart failure, tuberculosis
- •Subject with known or suspected human immunodeficiency virus infection
研究组 & 干预措施
nebulized Budesonide 2mg/4mL
+terbutaline 5mg/2mL,BID+ipratropium 2 puff(40ug)BID
干预措施: Budesonide (Drug)
结局指标
主要结局
The incidence of post-operation pulmonary complication in two arms among primary lung cancer patients with COPD
时间窗: 10 days
Definition of post-operation pulmonary complication: 1. Pneumonia/other pulmonary infections, with X-ray evidence, fever and/or WBC\>15,000mL 2. Sputum retention:classified as purulent and the pour ability grade is 1 or 2 3. Acute respiratory failture or chronic respiratory failture 4. Atelectasis 5. Aerothorax:\>30% by X-ray; pulmonary embolism
次要结局
未报告次要终点
研究者
Xiuyi Zhi
Professor
Xuanwu Hospital, Beijing