The Association of Different Levels of Physical Activity on Postoperative Pulmonary Complications in Patients Undergoing Thoracoscopic Lung Resection Surgery: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Incidence of pulmonary complications
研究概览
简要总结
This study aimed to predict different physical activity (PA) levels in patients undergoing thoracoscopic lung resection surgery (LRS) using the International Physical Activity Questionnaire (IPAQ) and investigate the association between the PA levels and the incidence of postoperative pulmonary complications (PPCs). The patients were classified into the high-level and low-level PA groups based on the IPAQ scores. The incidence of PPCs within postoperative 5 days, number of PPCs, the incidence of postoperative adverse events (PAEs) within postoperative 5 days, extubation time, length of hospital stay (LOS), unplanned admission to the intensive care unit (ICU), and the mortality 1-month postoperatively were recorded. Arterial blood samples were collected before induction of anesthesia and 1 hour postoperatively, and the supernatants were centrifuged for cytokine analysis. Binomial logistic analysis was performed to determine the relationship between predefined variables and PPCs. Receiver operating characteristic (ROC) curve analysis was performed to identify independent risk factors, and the area under the curve (AUC) was calculated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years and younger than 80 years;
- •Patients scheduled to accept elective thoracic surgery under general anesthesia;
- •Patients of American Society of Anesthesiologists (ASA) Ⅱ～Ⅲ level grade;
- •Patients signed the informed consent form for the clinical study.
排除标准
- •Patients with moderate or severe chronic obstructive pulmonary disease (GOLD Grade III or IV level grade)；
- •Patients with severe or uncontrolled bronchial asthma；
- •Patients with severe neuromuscular disease or thoracic malformation；
- •Patients with severe heart disease (New York Heart Association Class III or IV level grade or acute coronary syndrome or persistent ventricular arrhythmia)；
- •Patients with cognitive dysfunction；
- •Patients who have participated in other clinical trials within the previous 30 days；
- •Patients with coagulation dysfunction；
- •Patients who received radiotherapy or chemotherapy within 2 months before surgery.
结局指标
主要结局
Incidence of pulmonary complications
时间窗: Within five days after surgery
1. Respiratory Infection 2. Respiratory Failure 3. Pleural Effusion 4. Atelectasis 5. Pneumothorax 6. Bronchospasm 7. Aspiration pneumonitis
次要结局
- The number of postoperative pulmonary complications(Within five days after the surgery)
- Extubation time(The time from the end of surgery to the removal of the endotracheal intubation.)
- The arterial levels of inflammatory markers(before induction of anesthesia(T0),1.5 hours after the beginning of surgery(T2),3 hours after the beginning of surgery(T3)and 1 hour after the end of surgery(T4).)
- Mortality 1 month after surgery(Within 1 month of the end of surgery)
- Postoperative length of stay(During the study procedure)
- Incidence of postoperative adverse events(Within five days after operation)
- Unplanned admission to the ICU(Within five days after operation)
研究者
Changping Gu
Professor
Qianfoshan Hospital