Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

590 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-06

Study Completion Date

2026-01-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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

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.

Group Type EXPERIMENTAL

immunonutrition

Intervention Type DIETARY_SUPPLEMENT

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.

oral chlorhexidine decontamination

Intervention Type BEHAVIORAL

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.

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

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.

Group Type EXPERIMENTAL

immunonutrition

Intervention Type DIETARY_SUPPLEMENT

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.

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

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.

Group Type EXPERIMENTAL

oral chlorhexidine decontamination

Intervention Type BEHAVIORAL

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.

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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immunonutrition

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.

Intervention Type DIETARY_SUPPLEMENT

oral chlorhexidine decontamination

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No