Gut Microbiota and Pulmonary Complications After Non Cardiac Elective Surgery in Elderly Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorPeking Union Medical College Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age: ≥ 65 years old;
Surgery: Upper abdominal surgery (expected duration ≥ 2 hours);
Anesthesia methods: general anesthesia, tracheal intubation;
ASA classification: I-IV levels;
Disqualifiers
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
Trial population
Elderly patients over 65 years old who plan to undergo elective upper abdominal surgery
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Elective upper abdominal surgery
Procedure/SurgeryThe included elderly patients are those who are preparing for elective upper abdominal surgery and the surgery time exceeds 2 hours.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PPCs+ group1 intervention
Group B: PPCs- group1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with postoperative pulmonary complications
Including pneumonia, atelectasis, and hypoxemia
Time frame
Within 7 days after surgerySecondary outcomes
1
Number of inflammatory cells in peripheral blood before and after surgery
Inflammatory cells include white blood cells, neutrophil count, and lymphocyte count
Time frame
Before and within 7 days after surgery2
Concentration of inflammatory cytokines in peripheral blood before and after surgery
Inflammatory factors include high-sensitivity C-reactive protein (CRP) and procalcitonin (PCT)
Time frame
Before and within 7 days after surgerySponsors and contacts
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Source ClinicalTrials.gov