Preoperative Diagnostic Tests for Pulmonary Risk Assessment in Patients With Chronic Obstructive Pulmonary Disease (COPD) Undergoing Major Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 365
- 试验地点
- 1
- 主要终点
- Composite end point of postoperative pulmonary complications (PPC) or all cause in-hospital mortality
研究概览
简要总结
This prospective study intends to investigate the incidence of postoperative pulmonary complications (PPC) or in-hospital mortality in patients with COPD or at risk for COPD undergoing high-risk noncardiac major surgery and to identify relevant risk factors. This study aims to quantify and compare the diagnostic performance of preoperative functional tests, exercise capacity, clinical assessment tests and predictive scoring systems to predict PPC or in-hospital mortality in these patients.
详细描述
COPD is associated with high perioperative morbidity and mortality and PPC frequently occur in these patients. However, concepts for preoperative pulmonary risk assessment and the predictive value of routine preoperative exercise capacity, clinical assessment and pulmonary function tests are still poorly characterized.
Objectives:
- To determine the incidence of the composite end point of PPC or all cause in-hospital mortality in patients with confirmed COPD (spirometry) and patients with clinical risk factors in whom spirometry disproved COPD.
- To determine the predictive value of exercise capacity, clinical assessment tests, pulmonary function tests and predictive scoring systems to predict the composite end point in these patients.
- To identify relevant risk factors and predictors associated with the composite end point.
Methodology:
Prospective single-centre observational study
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •High-risk noncardiac major surgery with an anticipated operation time ≥ 120 minutes and/or planned postoperative intensive care unit admission
- •Typical clinical signs for COPD (dyspnea, chronic cough, chronic sputum production, exposure to risk factors)
- •Confirmed COPD (medical history) or clinical risk factors for COPD
- •Positive COPD Assessment Test (CAT™)
排除标准
- •< 18 Years
- •Pregnancy
- •Lack of cooperation
- •Inability to provide functional tests like spirometry or stairclimbing
结局指标
主要结局
Composite end point of postoperative pulmonary complications (PPC) or all cause in-hospital mortality
时间窗: until hospital discharge up to 6 months after surgery
次要结局
- Frequency of unplanned intensive care unit admission, prolonged oxygen requirement, reintubation, non-invasive ventilation (NIV) or extracorporeal lung assist(until hospital discharge up to 6 months after surgery)
- Carbon dioxide (pCO2) and oxygen (pO2) partial pressures from blood gas analysis(within 1 week after extubation)
- Duration of postoperative respirator support (h)(until hospital discharge up to 6 months after surgery)
- Length of stay in the intensive care unit (days)(until hospital discharge up to 6 months after surgery)
- Duration of hospitalization (days)(until hospital discharge up to 6 months after surgery)
- Forced expiratory volume in one second to forced vital capacity ratio (FEV1/FVC) and FEV1 % predicted(within 1 week after extubation)
- New pulmonary radiological findings (e.g. pneumonia or pneumothorax)(until hospital discharge up to 6 months after surgery)
- Postoperative new respiratory symptoms (e.g. dyspnea or wheezing) or treatment for exacerbation (e.g. new systemic glucocorticosteroids or bronchodilators)(until hospital discharge up to 6 months after surgery)