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

Recruiting

• Conditions: Gut Microbiota; Postoperative Pulmonary Complications
• Interventions: Procedure: Elective upper abdominal surgery

• Registration Number: NCT06513416
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age: ≥ 65 years old;
2. Surgery: Upper abdominal surgery (expected duration ≥ 2 hours);
3. Anesthesia methods: general anesthesia, tracheal intubation;
4. ASA classification: I-IV levels;
5. Postoperative Pulmonary Complications Risk Score (ARISCAT): Medium to High Risk
6. 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

1. Emergency surgery;
2. This is the second surgery within the past month;
3. Preoperative presence of pulmonary infection or other serious pulmonary complications
4. Patients who have used antibiotics, probiotics, and acid suppressants within one month before surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PPCs+ group	Elective upper abdominal surgery	Patients who experienced postoperative pulmonary complications belong to the PPC positive group
PPCs- group	Elective upper abdominal surgery	Patients who experienced no postoperative pulmonary complications belong to the PPC negative group

Primary Outcome Measures

Name	Time	Method
Number of participants with postoperative pulmonary complications	Within 7 days after surgery	Including pneumonia, atelectasis, and hypoxemia

Secondary Outcome Measures

Name	Time	Method
Number of inflammatory cells in peripheral blood before and after surgery	Before and within 7 days after surgery	Inflammatory cells include white blood cells, neutrophil count, and lymphocyte count
Concentration of inflammatory cytokines in peripheral blood before and after surgery	Before and within 7 days after surgery	Inflammatory factors include high-sensitivity C-reactive protein (CRP) and procalcitonin (PCT)

Trial Locations

Locations (1)

Department of Anesthesiology, Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China