Postoperative Complications, Pulmonary Complication
Conditions
Keywords
immunonutrition, oral decontamination, postoperative pulmonary complications
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.
Interventions
DIETARY_SUPPLEMENTimmunonutrition supplement of ORAL IMPACT™
For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery.
For intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery.
Sponsors
Fujian Provincial Hospital
The Second Hospital of Hebei Medical University
Shenzhen Qianhai Shekou Free Trade Zone Hospital
Ningbo No.2 Hospital
Peking University International Hospital
Guizhou Provincial People's Hospital
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 complications | within 7days and 30 days after surgery | defined using comprehensive complication index |
| postoperative pneumonia | within 7days and 30 days after surgery | defined according to the US Centers for Disease Control Definition |
| hospitalization expenses | upon hospital discharge, typically 1-2 weeks | total expense during the hospital stay |
| length of hospital stay | upon hospital discharge，typically 1-2 weeks | days of in hospital stay |
| postoperative recovery | within 7days and 30 days after surgery | assessed by 15-item quality of recovery questionnaire and WHO disability assessment schedule 2.0 |
Countries
China
Contacts
Primary ContactLu Che, Dr
Outcome results
None listed