Gut Microbiota and Pulmonary Complications After Non Cardiac Elective Surgery in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 2
- 主要终点
- Number of participants with postoperative pulmonary complications
研究概览
简要总结
An observational cohort was established using preoperatively collected biospecimens and prospectively ascertained postoperative outcomes. A nested case-control metagenomic analysis was subsequently conducted within the cohort, including participants with grade II or higher PPCs and selected participants without PPCs.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥ 65 years old;
- •Surgery: Major abdominal surgery (expected duration ≥ 2 hours);
- •Anesthesia methods: general anesthesia, tracheal intubation;
- •ASA classification: I-IV levels;
- •Postoperative Pulmonary Complications Risk Score (ARISCAT): Medium to High Risk
- •Patients or their families are able to understand the research protocol and are willing to participate in this study, providing written informed consent
排除标准
- •Emergency surgery;
- •This is the second surgery within the past month;
- •Preoperative presence of pulmonary infection or other serious pulmonary complications
- •Patients who have used antibiotics, probiotics, and acid suppressants within one month before surgery
研究组 & 干预措施
Elderly surgical patients
Adults aged 65 years or older undergoing major non-cardiac surgery of expected duration of at least 2 hours under general anesthesia with tracheal intubation. Participants are followed for postoperative pulmonary complications within 7 days after surgery, and preoperative biospecimens are collected when feasible with participant consent.
干预措施: Elective abdominal surgery (Procedure)
结局指标
主要结局
Number of participants with postoperative pulmonary complications
时间窗: Within 7 days after surgery
The primary outcome is the occurrence of one or more ppcs, including primarily hypoxemia, atelectasis, and pneumonia, etc.
次要结局
- Number of inflammatory cells in peripheral blood before and after surgery(Before and within 7 days after surgery)
- Concentration of inflammatory cytokines in peripheral blood before and after surgery(Before and within 7 days after surgery)
- Preoperative gut microbiome composition(Preoperative, before bowel preparation and prophylactic antibiotics)
研究者
Huang YuGuang
Chief physician
Peking Union Medical College Hospital