NCT06513416 Gut Microbiota and Pulmonary Complications After Non Cardiac Elective Surgery in Elderly Patients
| NCT ID | NCT06513416 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Gut Microbiota |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-02-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06513416 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Gut Microbiota. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06513416 currently recruiting?
Yes, NCT06513416 is actively recruiting participants. Contact the research team at zhuqm661@163.com for enrollment information.
Where is the NCT06513416 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06513416 clinical trial?
NCT06513416 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 100 participants.