Perioperative Oral decontamination and ImmunoNuTrition (POINT) to prevent postoperative pulmonary complications in elderly patients scheduled for elective non-cardiac surgeries: protocol for a multicentre, randomised controlled trial
Introduction Elderly patients are known to be vulnerable to postoperative pulmonary complications (PPCs), especially pneumonia. Apart from elder age, preoperative pulmonary diseases, anaemia, malnutrition, dysphagia and frailty may all be contributing factors to PPCs. Poor oral hygiene is a risk fac...
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BMJ Publishing Group
2025-05-01
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| author | Jing Zhang Yuguang Huang Wen Wang Yuelun Zhang Xiaochun Zheng Lu Che Junping Chen Lan Yao Jiawen Yu Lining Huang Qianmei Zhu Lichi Xu Ji Fu Meizheng You Chaolei Liu Guoping Fan |
| author_facet | Jing Zhang Yuguang Huang Wen Wang Yuelun Zhang Xiaochun Zheng Lu Che Junping Chen Lan Yao Jiawen Yu Lining Huang Qianmei Zhu Lichi Xu Ji Fu Meizheng You Chaolei Liu Guoping Fan |
| author_sort | Jing Zhang |
| collection | DOAJ |
| description | Introduction Elderly patients are known to be vulnerable to postoperative pulmonary complications (PPCs), especially pneumonia. Apart from elder age, preoperative pulmonary diseases, anaemia, malnutrition, dysphagia and frailty may all be contributing factors to PPCs. Poor oral hygiene is a risk factor for PPC as well, as oropharyngeal microflora might be introduced to the lower respiratory tract following endotracheal intubation for general anaesthesia during surgery. Immune regulation, nutrition supplementation and improvement of oropharyngeal microflora might regulate immune and stress response and can be beneficial to elderly patients exposed to surgical stress. In this study, we will explore the effects of perioperative oral decontamination and immunonutrition supplementation on the incidence of postoperative pneumonia in high-risk elderly surgical patients.Methods and analysis This study is a multicentre, two-by-two factorial randomised controlled trial evaluating the efficacy of immunonutrition supplementation and oral chlorhexidine decontamination. A total of 592 patients aged 65 years and older who are scheduled for elective non-cardiac surgeries in seven tertiary hospitals in China will be recruited. Patients will be excluded if they have contraindications to the intervention. Patients will be randomised into four groups in a 1:1:1:1 ratio (oral decontamination vs routine oral care, immunonutrition supplementation vs routine nutrition advice). The primary outcome is the incidence of PPCs within 7 days after surgery. The secondary outcomes are the incidence of postoperative pneumonia, infectious complications, Comprehensive Complication Index, postoperative functional recovery, length of hospital stay and hospital expenses. Intention to treat principles will be applied to all outcomes. Descriptive analysis will be used to compare patients’ baseline characteristics. Logistic regression will be used to compare the incidence of PPCs within 7 days after surgery between different groups.Ethics and dissemination The study protocol has been approved by the Research Ethics Committee of Peking Union Medical College Hospital (I-23PJ953). All participants will provide written informed consent. Study results will be published in peer-reviewed journals and presented at academic conferences.Trial registration number NCT05971810. |
| format | Article |
| id | doaj-art-43e80facefdd4ef89c15490134121e7c |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-43e80facefdd4ef89c15490134121e7c2025-08-20T03:49:40ZengBMJ Publishing GroupBMJ Open2044-60552025-05-0115510.1136/bmjopen-2024-092068Perioperative Oral decontamination and ImmunoNuTrition (POINT) to prevent postoperative pulmonary complications in elderly patients scheduled for elective non-cardiac surgeries: protocol for a multicentre, randomised controlled trialJing Zhang0Yuguang Huang1Wen Wang2Yuelun Zhang3Xiaochun Zheng4Lu Che5Junping Chen6Lan Yao7Jiawen Yu8Lining Huang9Qianmei Zhu10Lichi Xu11Ji Fu12Meizheng You13Chaolei Liu14Guoping Fan15Department of Anesthesiology, Shenzhen Qianhai and Shekou Free Trade Zone Hospital, Shenzhen, ChinaDepartment of Anesthesiology, Peking Union Medical College Hospital, Beijing, ChinaDepartment of Anesthesiology, Peking University International Hospital, Beijing, ChinaMedical Research Center, Peking Union Medical College Hospital, Beijing, ChinaDepartment of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, ChinaDepartment of Anesthesiology, Peking Union Medical College Hospital, Beijing, ChinaClinic Center of Anesthesiology and Pain, Ningbo No.2 Hospital, Ningbo, ChinaDepartment of Anesthesiology, Peking University International Hospital, Beijing, ChinaDepartment of Anesthesiology, Peking Union Medical College Hospital, Beijing, ChinaDepartment of Anesthesiology, The Second Hospital of Hebei Medical University, Shijiazhuang, ChinaDepartment of Anesthesiology, Peking Union Medical College Hospital, Beijing, ChinaDepartment of Anesthesiology, Peking Union Medical College Hospital, Beijing, ChinaDepartment of Clinical Nutrition, Peking Union Medical College Hospital, Beijing, ChinaDepartment of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, ChinaDepartment of Anesthesiology, The Second Hospital of Hebei Medical University, Shijiazhuang, ChinaClinic Center of Anesthesiology and Pain, Ningbo No.2 Hospital, Ningbo, ChinaIntroduction Elderly patients are known to be vulnerable to postoperative pulmonary complications (PPCs), especially pneumonia. Apart from elder age, preoperative pulmonary diseases, anaemia, malnutrition, dysphagia and frailty may all be contributing factors to PPCs. Poor oral hygiene is a risk factor for PPC as well, as oropharyngeal microflora might be introduced to the lower respiratory tract following endotracheal intubation for general anaesthesia during surgery. Immune regulation, nutrition supplementation and improvement of oropharyngeal microflora might regulate immune and stress response and can be beneficial to elderly patients exposed to surgical stress. In this study, we will explore the effects of perioperative oral decontamination and immunonutrition supplementation on the incidence of postoperative pneumonia in high-risk elderly surgical patients.Methods and analysis This study is a multicentre, two-by-two factorial randomised controlled trial evaluating the efficacy of immunonutrition supplementation and oral chlorhexidine decontamination. A total of 592 patients aged 65 years and older who are scheduled for elective non-cardiac surgeries in seven tertiary hospitals in China will be recruited. Patients will be excluded if they have contraindications to the intervention. Patients will be randomised into four groups in a 1:1:1:1 ratio (oral decontamination vs routine oral care, immunonutrition supplementation vs routine nutrition advice). The primary outcome is the incidence of PPCs within 7 days after surgery. The secondary outcomes are the incidence of postoperative pneumonia, infectious complications, Comprehensive Complication Index, postoperative functional recovery, length of hospital stay and hospital expenses. Intention to treat principles will be applied to all outcomes. Descriptive analysis will be used to compare patients’ baseline characteristics. Logistic regression will be used to compare the incidence of PPCs within 7 days after surgery between different groups.Ethics and dissemination The study protocol has been approved by the Research Ethics Committee of Peking Union Medical College Hospital (I-23PJ953). All participants will provide written informed consent. Study results will be published in peer-reviewed journals and presented at academic conferences.Trial registration number NCT05971810.https://bmjopen.bmj.com/content/15/5/e092068.full |
| spellingShingle | Jing Zhang Yuguang Huang Wen Wang Yuelun Zhang Xiaochun Zheng Lu Che Junping Chen Lan Yao Jiawen Yu Lining Huang Qianmei Zhu Lichi Xu Ji Fu Meizheng You Chaolei Liu Guoping Fan Perioperative Oral decontamination and ImmunoNuTrition (POINT) to prevent postoperative pulmonary complications in elderly patients scheduled for elective non-cardiac surgeries: protocol for a multicentre, randomised controlled trial BMJ Open |
| title | Perioperative Oral decontamination and ImmunoNuTrition (POINT) to prevent postoperative pulmonary complications in elderly patients scheduled for elective non-cardiac surgeries: protocol for a multicentre, randomised controlled trial |
| title_full | Perioperative Oral decontamination and ImmunoNuTrition (POINT) to prevent postoperative pulmonary complications in elderly patients scheduled for elective non-cardiac surgeries: protocol for a multicentre, randomised controlled trial |
| title_fullStr | Perioperative Oral decontamination and ImmunoNuTrition (POINT) to prevent postoperative pulmonary complications in elderly patients scheduled for elective non-cardiac surgeries: protocol for a multicentre, randomised controlled trial |
| title_full_unstemmed | Perioperative Oral decontamination and ImmunoNuTrition (POINT) to prevent postoperative pulmonary complications in elderly patients scheduled for elective non-cardiac surgeries: protocol for a multicentre, randomised controlled trial |
| title_short | Perioperative Oral decontamination and ImmunoNuTrition (POINT) to prevent postoperative pulmonary complications in elderly patients scheduled for elective non-cardiac surgeries: protocol for a multicentre, randomised controlled trial |
| title_sort | perioperative oral decontamination and immunonutrition point to prevent postoperative pulmonary complications in elderly patients scheduled for elective non cardiac surgeries protocol for a multicentre randomised controlled trial |
| url | https://bmjopen.bmj.com/content/15/5/e092068.full |
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