Postoperative Complications
Conditions
Brief summary
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.
Detailed 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).
Interventions
DIETARY_SUPPLEMENTimmunonutrition
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.
BEHAVIORALoral 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.
Sponsors
Huang YuGuang
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pulmonary complications | within 7 days after surgery | evaluated by trained investigator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pneumonia | within 7 days after surgery | defined according to the US Centers for Disease Control Definition |
| postoperative recovery | within 30 days after surgery | evaluated by QoR-15 and WHODAS2.0 |
| Comprehensive complication index (CCI) | within 30 days after surgery | postoperative complication evaluated using Comprehensive complication index |
| Length of hospital stay | From date of surgery until discharge day, assessed up to 4 weeks | Postoperative length of hospital stay assessed by days |
Countries
China
Contacts
Primary ContactLu Che, MD
Backup ContactJiawen Yu, MD
Outcome results
None listed