Improving recovery in elderly surgical patients with nutrition and oral care
Effect of Perioperative Immunonutrition Intervention and Oral Decontamination on Postoperative Complications in Elderly: a Prospective Randomized Controlled Trial
This study is testing if better nutrition and oral care can help older patients recover more smoothly after surgery and avoid complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 590 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05679661 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of perioperative oral decontamination and immunonutrition supplementation in reducing postoperative complications among elderly patients undergoing elective non-cardiac surgeries. It is a prospective, single-center, randomized controlled trial that will recruit patients aged 65 and older, who will be divided into four groups to receive different combinations of oral care and nutrition interventions. The aim is to assess whether these interventions can improve patient outcomes and reduce the risk of complications related to surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 65 and older scheduled for elective non-cardiac surgeries with a high risk of respiratory complications.
Not a fit: Patients undergoing emergency surgeries or those with severe pre-existing health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications in elderly patients, leading to better recovery and overall health outcomes.
How similar studies have performed: Other studies have shown promising results with similar interventions in improving postoperative outcomes, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Peking Union Medical College Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Yuguang Huang — Peking Union Medical College Hospital (CAMS)
- Study coordinator: Lu Che, MD
- Email: tracymaobao@126.com
- Phone: 69152020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.