Gut Microbiota and Pulmonary Complications After Non Cardiac Elective Surgery in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants with postoperative pulmonary complications
研究概览
简要总结
This study adopts a combination of retrospective and prospective cohort research methods to explore the composition of preoperative oropharyngeal and gut microbiota in elderly patients undergoing elective upper abdominal surgery, aiming to analyze the correlation between preoperative oropharyngeal and intestinal microbiota composition and metabolite levels and the occurrence of postoperative pulmonary complications (PPCs). The research subjects of the retrospective cohort study were participants (ClinicalTrials.gov No. NCT05679661) included in the prospective RCT on the effects of perioperative immune nutrition intervention and oral hygiene on postoperative complications in elderly patients, which was conducted at Peking Union Medical College Hospital from January 2023 to present. The prospective cohort study plans to continue enrolling elderly patients aged ≥ 65 who underwent elective upper abdominal surgery.
This study collects preoperative oropharyngeal and fecal samples, as well as preoperative plasma from patients for microbial sequencing and untargeted metabolomics analysis. The main outcome measurement is PPCs, which include pneumonia, atelectasis, and hypoxemia within 7 days after surgery. Inflammatory cells and cytokines in peripheral blood are secondary outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
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: Upper 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
结局指标
主要结局
Number of participants with postoperative pulmonary complications
时间窗: Within 7 days after surgery
Including pneumonia, atelectasis, and hypoxemia
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)
研究者
Huang YuGuang
Chief physician
Peking Union Medical College Hospital