Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients

Huang YuGuang

Status: Enrolling

Conditions: Postoperative Complications

Treatments: Behavioral: oral chlorhexidine decontamination; Dietary Supplement: immunonutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT05679661

K2870

Details and patient eligibility

About

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.

Full 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).

Enrollment: 590 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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590 participants in 4 patient groups

Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: immunonutrition

Behavioral: oral chlorhexidine decontamination

Group B (immunonutrition and routine oral care, IN&RC)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: immunonutrition

Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)

Experimental group

Description:

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.

Treatment:

Behavioral: oral chlorhexidine decontamination

Group D (routine nutrition advice and routine oral care, RN&RC)

No Intervention group

Description:

Patients will be advised to follow a standard nutrition advice and routine oral care.