Gut Microbiota and Pulmonary Complications After Non Cardiac Elective Surgery in Elderly Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Elective upper abdominal surgery.
- Who it may be relevant to
- Registry conditions: Gut Microbiota, Postoperative Pulmonary Complications. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Elective upper abdominal surgery
The included elderly patients are those who are preparing for elective upper abdominal surgery and the surgery time exceeds 2 hours.
Primary outcome measures
- Number of participants with postoperative pulmonary complications [Time frame: Within 7 days after surgery]
Secondary outcome measures (2)
- Number of inflammatory cells in peripheral blood before and after surgery [Time frame: Before and within 7 days after surgery]
- Concentration of inflammatory cytokines in peripheral blood before and after surgery [Time frame: Before and within 7 days after surgery]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Department of Anesthesiology, Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT06513416 · K5484