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

NCT ID: NCT06513416

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Gut Microbiota Postoperative Pulmonary Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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PPCs+ group

Patients who experienced postoperative pulmonary complications belong to the PPC positive group

Elective upper abdominal surgery

Intervention Type PROCEDURE

The included elderly patients are those who are preparing for elective upper abdominal surgery and the surgery time exceeds 2 hours.

PPCs- group

Patients who experienced no postoperative pulmonary complications belong to the PPC negative group

Elective upper abdominal surgery

Intervention Type PROCEDURE

The included elderly patients are those who are preparing for elective upper abdominal surgery and the surgery time exceeds 2 hours.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Huang YuGuang

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qianmei Zhu

Role: CONTACT

18810651253

Facility Contacts

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Qianmei Zhu

Role: primary

18810651253

Other Identifiers

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K5484

Identifier Type: -

Identifier Source: org_study_id

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