Risk Factors for PPCs in Laparoscopic Non-Robotic vs Laparoscopic Robotic Abdominal Surgery (LapRas)- a Patient-Level Analysis of LAS VEGAS and AVATaR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,378
- 主要终点
- Postoperative pulmonary complications
研究概览
简要总结
This secondary analysis aims to identify factors associated with the development of postoperative pulmonary complications (PPCs) in patients undergoing abdominal surgery, pooling and analyzing the data of two worldwide prospective studies, the 'Epidemiology, Practice of Ventilation and Outcome for Patients at Increased Risk of Postoperative Pulmonary Complications' (LAS VEGAS, NCT01601223) and the 'Assessment of Ventilatory management during general AnesThesia for Robotic surgery and its effects on postoperative pulmonary complications' (AVATaR, NCT02989415).
The primary aim is to compare the incidence of PPCs between patients undergoing non-robotic surgery versus patients undergoing robot-assisted surgery. One secondary aim is to determine which factors are associated with the occurrence of PPCs. The investigators hypothesize that differences in the occurrence of PPCs between the two surgery groups are more driven by differences in duration of anesthesia than by the intensity of ventilation.
详细描述
This study involves a preplanned analysis of a merged database comprising individual patient data from two global observational studies on ventilation and postoperative pulmonary complications (PPCs). Both study protocols, the LAS VEGAS and AVATaR were approved by a central Institutional Review Board and local ethics committees, with written informed consent obtained as per local legislation. The pooled database, including modifications for patient categories, does not require additional ethical approval or informed consent. The analysis will adhere to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement.
Patients:
- The LAS VEGAS study includes patients undergoing general anesthesia with invasive ventilation for elective and non-elective surgeries.
- The AVATaR study includes patients aged over 18 undergoing robot-assisted surgery (RAS) for abdominal procedures.
Baseline Patient Characteristics:
- Key variables extracted from LAS VEGAS and AVATaR include demographic data, smoking status, comorbidities (chronic heart disease, obstructed sleep apnea syndrome, anemia, chronic kidney disease), and details about anesthesia and surgery.
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients receiving invasive ventilation (via either an endotracheal tube or supraglottic device) during general anaesthesia for elective or non-elective surgery.
排除标准
- •patients not undergoing laparoscopic surgery in LAS VEGAS, and not undergoing abdominal RAS in AVATaR;
- •patients undergoing combined thoracic-laparoscopic surgery and patients in whom the intervention was converted from laparoscopic or RAS to open surgery are excluded;
- •patients that received recent ventilation before surgery;
- •patients with incomplete ventilation datasets not allowing the computation of intensity of ventilation, and patients with an incomplete follow-up for PPCs are also excluded.
结局指标
主要结局
Postoperative pulmonary complications
时间窗: Postoperative day 5
Composite end-point of post-operative pulmonary complications (new onset of acute respiratory distress syndrome (ARDS), pneumonia, pneumothorax, acute respiratory failure, need of oxygen therapy, need for postoperative invasive or non-invasive mechanical ventilation)
次要结局
- In-hospital mortality(1 year)
- Hospital length of stay(1 year)