Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery and Its Effects on Postoperative Pulmonary Complications: A Prospective Observational Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,015
- 试验地点
- 12
- 主要终点
- Incidence of postoperative pulmonary complications
研究概览
简要总结
The aim of this study is to assess the incidence of postoperative pulmonary complications in patients undergoing mechanical ventilation during general anesthesia for robotic surgery, to characterize current practices of mechanical ventilation and to evaluate a possible association between ventilatory parameters and postoperative pulmonary complications.
详细描述
Research questions:
- What is the incidence of PPC in patients undergoing mechanical ventilation during general anesthesia for robotic surgery?
- Are the outcomes in patients undergoing robotic surgery dependent on ventilation practice and surgical positioning?
- What is the incidence of patients at high risk for PPC undergoing robotic surgery
Methods:
In this international observational study, consecutive patients undergoing mechanical ventilation for robotic surgery are eligible for participation. Patients in participating centers will be screened on a daily basis. Patients undergoing mechanical ventilation for robotic surgery will be included during a 30-day period. The inclusion period will be flexible for participating centers and determined at a later stage together with the study-coordinator.
Time points of data collection:
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
- •Age ≥ 18 years
- •All surgical procedures performed under general anesthesia for robotic surgery, including head and neck operations, chest, cardiac, and abdominal surgeries
排除标准
- •Any procedure during pregnancy
- •Procedures outside of the operating room
结局指标
主要结局
Incidence of postoperative pulmonary complications
时间窗: Five days or until hospital discharge, whichever occurs first
Composite of five postoperative pulmonary complications
次要结局
- Mechanical ventilation practice(Intraoperatively)
- Mechanical ventilation practice and postoperative pulmonary complications(Five days or until hospital discharge, whichever occurs first)
- Patients at high risk for postoperative pulmonary complications(Pre-operatively)
- Mechanical ventilation practice and intraoperative complications(Intraoperatively)
- Surgical positioning and ventilation(Intraoperatively)
研究者
Ary Serpa Neto
MD, MSc, PhD
Hospital Israelita Albert Einstein