Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly

Not Applicable

Recruiting

• Conditions: Pulmonary Complication; Postoperative Complications
• Interventions: Dietary Supplement: immunonutrition supplement of ORAL IMPACT™; Other: oral chlorhexidine decontamination

• Registration Number: NCT05971810
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-07-21
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-02
• Study Start: 2023-08-23
• Status Verified: 2024-07
• Last Update Submitted: 2025-01-25
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-08-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 592

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)	immunonutrition supplement of ORAL IMPACT™	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.
Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)	oral chlorhexidine decontamination	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.
Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)	oral chlorhexidine decontamination	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.
Group B (immunonutrition and routine oral care, IN&RC)	immunonutrition supplement of ORAL IMPACT™	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.

Primary Outcome Measures

Name	Time	Method
postoperative pulmonary complications	within 7 days after surgery	composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Peking Union Medical College Hospital; 🇨🇳 Peking, China

The Second Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China