Comparison of Supraglottic Airway and Tracheal Intubation on Postoperative Pulmonary Complications Among High-risk Geriatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,210
- 主要终点
- PPC
研究概览
简要总结
Postoperative pulmonary complications are serious threat to surgical patients, especially to high-risk geriatric patients. There is evidence that laryngeal mask airway is associated with postoperative pulmonary complications in comparison with tracheal intubation. However, conclusion may reverse among frail population such as high-risk geriatric patients. Geriatric patients are often associated with loose mask seal due to physiological changes, which may increase chances of aspiration and pose challenges to intraoperative airway maintenance. It was reported that laryngeal mask airway causes more atelectasis among children, but no report among high-risk elderly. The investigators therefore propose this study to verify the non-inferior effect of laryngeal mask airway compared to tracheal intubation on postoperative pulmonary complications among high-risk geriatric patients undergoing elective non-cardiothoracic surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 70 years scheduled for elective non-cardiothoracic surgery with an ARISCAT score > 44 will be included
排除标准
- •Exclusion criteria include emergency surgery; anticipated difficult tracheal intubation; laryngeal pathology that might interfere with supraglottic device insertion; high risk of gastroesophageal reflux; participation in any conflicting trial within the past 3 months; or deemed unsuitable for the trial by investigators.
结局指标
主要结局
PPC
时间窗: 7 days after surgery
The primary outcome is the incidence of a collapsed composite of postoperative pulmonary complications within 7 postoperative days, diagnosed according to Dr Wang's work published on Anesthesiology, 2022 (PMID: 35226725).
次要结局
- extrapulmonary complications(7 days after surgery)
- severity of PPC(7 days after surgery)
- diagnosis of PPC(7 days after surgery)
