Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly
Perioperative Oral Decontamination and ImmunoNuTrition (POINT) on Postoperative Pulmonary Complications in Elderly: a Multicenter Randomized Controlled Trial
Peking Union Medical College Hospital
592 participants
Aug 23, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria5
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery.
For intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05971810