Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly

Study Overview
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Brief Summary
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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.

Detailed Description
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This study is a prospective, multicenter, two-by-two factorial randomized controlled trial evaluating the efficacy of immunonutrition supplementation and oral chlorhexidine decontamination. Patients aged 65 years and older who are scheduled for elective non-cardiac surgeries will be recruited. Participants will be excluded if they have contraindication to the intervention. The patients will be randomized into four groups in 1:1:1:1 ratio (oral decontamination vs routine oral care, immunonutrition supplementation vs routine nutrition advice). The primary outcome is the incidence of postoperative pulmonary complications within 7 days after surgery. Secondary outcomes include incidence of pneumonia, infectious complications, comprehensive complication index, postoperative functional recovery, length of hospital stay and hospital expense.

Official Title
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Perioperative Oral Decontamination and ImmunoNuTrition (POINT) on Postoperative Pulmonary Complications in Elderly: a Multicenter Randomized Controlled Trial

Conditions
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Postoperative Complications, Pulmonary Complication

Intervention / Treatment
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* Dietary Supplement: immunonutrition supplement of ORAL IMPACT™
* Other: oral chlorhexidine decontamination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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 in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. Patients will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3. | Dietary Supplement: immunonutrition supplement of ORAL IMPACT™<br>* For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery.<br>Other: oral chlorhexidine decontamination<br>* For intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery.<br>|
| Experimental: Group B (immunonutrition and routine oral care, IN&RC)<br>Patients in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. For oral health care, they will receive routine oral care which is routine toothbrushing twice daily. | Dietary Supplement: immunonutrition supplement of ORAL IMPACT™<br>* For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery.<br>|
| Experimental: Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)<br>Patients in this group 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. They will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3. | Other: oral chlorhexidine decontamination<br>* For intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery.<br>|
| No Intervention: Group D (routine nutrition advice and routine oral care, RN&RC)<br>Patients in this group 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. They will also receive routine oral care which is routine toothbrushing twice daily. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pulmonary complications | composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc. | 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 7days and 30 days after surgery | 
| postoperative pulmonary complications | composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc. | within 30 days after surgery | 
| postoperative infectious complications | composite outcome including surgical site infection, respiratory infection, urinary tract infection, intra-abdominal infection, blood stream infection, etc. | within 7days and 30 days after surgery | 
| postoperative complications | defined using comprehensive complication index | within 7days and 30 days after surgery | 
| postoperative recovery | assessed by 15-item quality of recovery questionnaire and WHO disability assessment schedule 2.0 | within 7days and 30 days after surgery | 
| hospitalization expenses | total expense during the hospital stay | upon hospital discharge, typically 1-2 weeks | 
| length of hospital stay | days of in hospital stay | upon hospital discharge，typically 1-2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunonutrition, oral decontamination, postoperative pulmonary complications