Gut Microbiota and Pulmonary Complications After Non Cardiac Elective Surgery in Elderly Patients
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Elective upper abdominal surgery.
- Кому может быть актуально
- Состояния в реестре: Gut Microbiota, Postoperative Pulmonary Complications. Базовые параметры: от 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
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.
Вмешательства
- Процедура 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.
Первичные конечные точки
- Number of participants with postoperative pulmonary complications [Срок оценки: Within 7 days after surgery]
Вторичные конечные точки (2)
- Number of inflammatory cells in peripheral blood before and after surgery [Срок оценки: Before and within 7 days after surgery]
- Concentration of inflammatory cytokines in peripheral blood before and after surgery [Срок оценки: Before and within 7 days after surgery]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Китай · 1 центр
- Department of Anesthesiology, Peking Union Medical College Hospital — Пекин
Идентификаторы
NCT: NCT06513416 · K5484