Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly
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 immunonutr
| Condition(s) | Postoperative Complications, Pulmonary Complication |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. age≥65 years; 2. undergoing major non-cardiac surgery; 3. scheduled for general anesthesia and endotracheal intubation; 4. American Society of Anesthesiologists (ASA) physical status classification I-IV; 5. with intermediate to high risk of respiratory complications assessed by Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score; 6. informed consent obtained. Exclusion Criteria: 1. emergency surgery; 2. preoperative pneumonia; 3. allergic to chlorhexidine; 4. severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases, taking immunosuppressant or immunoregulation medications, or with other contraindication to immunonutrition supplementation; 5. expected intervention of immunonutrition\<3 days. |
| Ages | 65 Years |
| Sex | All |
| Lead sponsor | Peking Union Medical College Hospital |
| Locations | Shijiazhuang, Hebei, China; Beijing, China |
| Start date | 2023-08-23 |
| NCT ID | NCT05971810 |
| Official listing | https://clinicaltrials.gov/study/NCT05971810 |