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Recruiting NCT05971810

Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly

Trial Parameters

Condition Postoperative Complications
Sponsor Peking Union Medical College Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 592
Sex ALL
Min Age 65 Years
Max Age N/A
Start Date 2023-08-23
Completion 2025-08-01
Interventions
immunonutrition supplement of ORAL IMPACT™oral chlorhexidine decontamination

Brief 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 Criteria

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.

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