Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients

Study Overview
=================
Brief Summary
-----------------
Elderly patients are vulnerable to postoperative complications. Preoperative malnutrition and poor oral hygiene are risk factors for postoperative complications especially pulmonary complications. This study aims to investigate the feasibility and efficacy of perioperative oral decontamination and immunonutrition supplement on reducing postoperative complications in elderly surgical patients.

Detailed Description
-----------------
This study is a prospective, single center, two-by-two factorial randomized controlled trial to evaluate the feasibility and efficacy of perioperative oral chlorhexidine decontamination and immunonutrition supplementation on postoperative complications in elderly surgical patients. Patients aged 65 years and older who are scheduled for elective non-cardiac surgeries will be recruited and randomized into four groups in 1:1:1:1 ratio (oral decontamination vs routine oral care with/without immunonutrition supplementation).

Official Title
-----------------
Effect of Perioperative Immunonutrition Intervention and Oral Decontamination on Postoperative Complications in Elderly: a Prospective Randomized Controlled Trial

Conditions
-----------------
Postoperative Complications

Intervention / Treatment
-----------------
* Dietary Supplement: immunonutrition
* Behavioral: oral chlorhexidine decontamination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age≥65 years; undergoing non-cardiac surgery (expected duration >2 hours); scheduled for general anesthesia and endotracheal intubation; ASA classification I-IV; with intermediate to high risk of respiratory complications assessed by ARISCAT score (Assess Respiratory Risk in Surgical Patients in Catalonia); inform 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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)<br>Patients will receive immunonutrition supplement of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery and oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3. | Dietary Supplement: immunonutrition<br>* Patients in the intervention group will receive additional immunonutrition supplementation, which is oral intake of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery.<br>Behavioral: oral chlorhexidine decontamination<br>* Patients in the intervention group will receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.<br>|
| Experimental: Group B (immunonutrition and routine oral care, IN&RC)<br>Patients will receive immunonutrition supplement of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery and routine oral care. | Dietary Supplement: immunonutrition<br>* Patients in the intervention group will receive additional immunonutrition supplementation, which is oral intake of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery.<br>|
| Experimental: Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)<br>Patients 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. Patients will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3. | Behavioral: oral chlorhexidine decontamination<br>* Patients in the intervention group will receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.<br>|
| No Intervention: Group D (routine nutrition advice and routine oral care, RN&RC)<br>Patients will be advised to follow a standard nutrition advice and routine oral care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | evaluated by comprehensive complication index (CCI) | within 7 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pneumonia | defined according to the US Centers for Disease Control Definition | within 7 days after surgery | 
| postoperative recovery | evaluated by QoR-15 | within 30 days after surgery |