Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly

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.

Inclusion criteria

• age≥65 years;
• undergoing major non-cardiac surgery;
• scheduled for general anesthesia and endotracheal intubation;
• American Society of Anesthesiologists (ASA) physical status classification I-IV;
• with intermediate to high risk of respiratory complications assessed by Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score;
• informed consent obtained.

Exclusion criteria

• emergency surgery;
• preoperative pneumonia;
• allergic to chlorhexidine;
• severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases, taking immunosuppressant or immunoregulation medications, or with other contraindication to immunonutrition supplementation;
• expected intervention of immunonutrition<3 days.