Postoperative Pulmonary Complications in Major Abdominal Surgery: a Multicenter Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,542
- 试验地点
- 39
- 主要终点
- Postoperative pulmonary complications rate
研究概览
简要总结
Incidence of Postoperative Pulmonary Complications (PPCs) varies from 2% to 19%, according to the population under examination and the criteria used to define pulmonary complications. There is no univocal definition of PPCs. Usually physicians associate atelectasis, respiratory insufficiency, pneumonia, bronchospasm, necessity to reintubate. Moreover the evaluation of risk factors has become difficult.
The endpoint of this study is to determine the actual incidence of respiratory postoperative complications in patients undergoing general anesthesia for major abdominal surgery (general surgery, gynecology, urology).
This is an observational, descriptive, prospective, multicentric study. Investigators are going to enroll all the patients matching the inclusion criteria and follow them until discharge (clinical phase). Then they will be followed up until one year later.
详细描述
INTRODUCTION Pulmonary Postoperative Complications (PPCs) are among the most common causes of adverse events in the perioperative period and can determine a significant increase of mortality risk in hospitalization time.
Incidence of PPCs varies from 2% to 19%, according to the population under examination and the criteria used to define pulmonary complications. There is no univocal definition of PPCs. Usually physicians associate atelectasis, respiratory insufficiency, pneumonia, bronchospasm, necessity of tracheal reintubation. Moreover, the evaluation of risk factors is becoming increasingly difficult. Many aspects linked to the patient's conditions and postoperative anesthesiologic management have been demonstrated to influence the risk of developing PPCs. (with the endorsement of European Society of Anesthesiology) proposed a risk index based on seven perioperative parameters to predict PPCs probability.
Furthermore, patients who survive after pulmonary complications will still suffer from functional reductions and are at risk of having a decrease in medium and long-term survival.
PRIMARY END POINT To determine the actual incidence of respiratory postoperative complications in patients undergoing elective general anesthesia for major abdominal surgery (general surgery, urology, gynecology).
Respiratory complications are: pneumonia, respiratory insufficiency, pleural effusion, pneumothorax, atelectasis, ab ingestis pneumonia, necessity of oxygen supply, non invasive mechanical ventilation (NIMV) or tracheal reintubation.
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
- •Patients ≥ 18 years
- •Ability to provide informed consent
- •Elective surgery
- •Laparotomic or laparoscopic major abdominal surgery
- •Major urological surgery (performed under general anesthesia)
- •Major gynecological surgery (performed under general anesthesia)
排除标准
- •Patients undergoing urgent or emergent surgery
- •Patients undergoing: vascular, thoracic ,cardiac surgery, neurosurgery, obstetrics procedures and transplantation surgery
- •Patients with chronic neuro-muscular junction disorders
- •Immunocompromised or immunodepressed patients
- •Patients with chronic or acute respiratory disease (acute respiratory infection, bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome)
- •Patients with preoperative mechanical ventilation
- •Patients with preoperative SpO2 <90%, PaO2 <60 mmHg (FiO2 0.21), or a PaO2/FiO2 ratio <300, or PaCO2 >45 mmHg.
结局指标
主要结局
Postoperative pulmonary complications rate
时间窗: From surgery to hospital discharge (an average of 10 days)
Complications are: respiratory infection, postoperative respiratory failure, pleural effusion, pneumothorax, atelectasis, aspiration pneumonia, bronchospasm, need of oxygen supplementation or noninvasive ventilatory support or unplanned urgent re-intubation
次要结局
- Intensive care unit length of stay(From surgery to hospital discharge (an average of 10 days))
- Postoperative pulmonary complications rate in general, gynecology and urology(From surgery to hospital discharge (an average of 10 days))
- Mortality rate after surgery(Up to 1 year after surgery)
- Length of hospital stay(From surgery to hospital discharge (an average of 10 days))
- Unplanned postoperative Intensive care unit (ICU) admission(From surgery to hospital discharge (an average of 10 days))
- Postoperative incidence of tracheal re-intubation(From surgery to hospital discharge (an average of 10 days))
- Postoperative incidence of infections(From surgery to hospital discharge (an average of 10 days))
- Postoperative incidence of cardiovascular complications(From surgery to hospital discharge (an average of 10 days))
- Postoperative incidence of PostOperative Residual Curarization (PORC)(Up to 3 hours after extubation)
研究者
Giorgio Della Rocca
MD, Principal Investigator
University of Udine