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| Name | Class |
|---|---|
| Fujian Provincial Hospital | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
| Shenzhen Nanshan District Shekou People's Hospital | OTHER |
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The goal of this multicenter randomized controlled trial is to explore the efficacy of perioperative oral decontamination and immunonutrition supplement to prevent postoperative pulmonary complications in elderly patients(≥65 years) receiving elective non-cardiac operations. Participants will be either given immunonutrition supplement versus routine nutrition advice, and oral chlorhexidine decontamination versus routine oral care randomly. The two interventions will be compared with control groups separately regarding postoperative pulmonary complications and other outcomes.
This study is a prospective, multicenter, two-by-two factorial randomized controlled trial evaluating the efficacy of immunonutrition supplementation and oral chlorhexidine decontamination. Patients aged 65 years and older who are scheduled for elective non-cardiac surgeries will be recruited. Participants will be excluded if they have contraindication to the intervention. The patients will be randomized into four groups in 1:1:1:1 ratio (oral decontamination vs routine oral care, immunonutrition supplementation vs routine nutrition advice). The primary outcome is the incidence of postoperative pulmonary complications within 7 days after surgery. Secondary outcomes include incidence of pneumonia, infectious complications, comprehensive complication index, postoperative functional recovery, length of hospital stay and hospital expense.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD) | Experimental | Patients in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. Patients will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3. |
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| Group B (immunonutrition and routine oral care, IN&RC) | Experimental | Patients in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. For oral health care, they will receive routine oral care which is routine toothbrushing twice daily. |
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| Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD) | Experimental | Patients in this group will be advised to follow a standard nutrition advice with a total intake of 30kcal/kg/d and protein intake of 1.2g/kg/d. They will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3. |
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| Group D (routine nutrition advice and routine oral care, RN&RC) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunonutrition supplement of ORAL IMPACT™ | Dietary Supplement | For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pulmonary complications | composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc. | within 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pneumonia | defined according to the US Centers for Disease Control Definition | within 7days and 30 days after surgery |
| postoperative pulmonary complications | composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Che, Dr | Contact | 69152020 | tracymaobao@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuguang Huang, Dr | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40374210 | Derived | Yu J, Che L, Zhu Q, Xu L, Fu J, Zhang Y, You M, Zheng X, Liu C, Huang L, Wang W, Yao L, Fan G, Chen J, Zhang J, Huang Y. 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. 2025 May 14;15(5):e092068. doi: 10.1136/bmjopen-2024-092068. |
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All data will be available from the corresponding author upon reasonable request.
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6 months after publication of study results.
Data will be available from the corresponding author upon reasonable request.
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Ningbo No.2 Hospital |
| OTHER |
| Peking University International Hospital | OTHER |
| Guizhou Provincial People's Hospital | OTHER |
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Patients in this group will be advised to follow a standard nutrition advice with a total intake of 30kcal/kg/d and protein intake of 1.2g/kg/d. They will also receive routine oral care which is routine toothbrushing twice daily. |
| oral chlorhexidine decontamination | Other | For intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery. |
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| within 30 days after surgery |
| postoperative infectious complications | composite outcome including surgical site infection, respiratory infection, urinary tract infection, intra-abdominal infection, blood stream infection, etc. | within 7days and 30 days after surgery |
| postoperative complications | defined using comprehensive complication index | within 7days and 30 days after surgery |
| postoperative recovery | assessed by 15-item quality of recovery questionnaire and WHO disability assessment schedule 2.0 | within 7days and 30 days after surgery |
| hospitalization expenses | total expense during the hospital stay | upon hospital discharge, typically 1-2 weeks |
| length of hospital stay | days of in hospital stay | upon hospital discharge，typically 1-2 weeks |
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
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