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NCT Number: NCT06513416

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Qianmei Zhu

CONTACT

[email protected]

18810651253

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elective upper abdominal surgery

Procedure

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

Primary outcomes

  1. Number of participants with postoperative pulmonary complications

    Time frame: Within 7 days after surgery

    Including pneumonia, atelectasis, and hypoxemia

Secondary outcomes

  1. Number of inflammatory cells in peripheral blood before and after surgery

    Time frame: Before and within 7 days after surgery

    Inflammatory cells include white blood cells, neutrophil count, and lymphocyte count

  2. Concentration of inflammatory cytokines in peripheral blood before and after surgery

    Time frame: Before and within 7 days after surgery

    Inflammatory factors include high-sensitivity C-reactive protein (CRP) and procalcitonin (PCT)

Study contacts

Contact information is provided by the study sponsor or research team.

Qianmei Zhu

CONTACT

[email protected]

18810651253

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2024
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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