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临床试验/NCT06513416
NCT06513416招募中不适用

Gut Microbiota and Pulmonary Complications After Non Cardiac Elective Surgery in Elderly Patients

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年2月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Huang YuGuang

Chief physician

Peking Union Medical College Hospital

研究点 (1)

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