Preventing postoperative complications in elderly patients through oral care and nutrition
Perioperative Oral Decontamination and ImmunoNuTrition (POINT) on Postoperative Pulmonary Complications in Elderly: a Multicenter Randomized Controlled Trial
This study is testing if special oral care and nutrition can help older patients avoid lung problems after they have non-heart surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 592 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 2 sites (Shijiazhuang, Hebei and 1 other locations) |
| Trial ID | NCT05971810 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial aims to evaluate the effectiveness of perioperative oral decontamination and immunonutrition supplementation in preventing postoperative pulmonary complications in elderly patients aged 65 and older undergoing elective non-cardiac surgeries. Participants will be randomly assigned to receive either immunonutrition supplements or routine nutrition advice, and oral chlorhexidine decontamination or routine oral care. The study will compare the incidence of postoperative pulmonary complications and other related outcomes between the intervention and control groups. The primary outcome will be assessed within 7 days post-surgery, with secondary outcomes including pneumonia incidence, functional recovery, and hospital stay duration.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 65 and older who are scheduled for elective non-cardiac surgeries and assessed to be at intermediate to high risk for respiratory complications.
Not a fit: Patients undergoing emergency surgeries or those with pre-existing conditions that contraindicate the interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of postoperative pulmonary complications in elderly patients, improving their recovery and overall health outcomes.
How similar studies have performed: Other studies have shown promising results with similar approaches in reducing postoperative complications, suggesting that this study builds on established concepts.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shijiazhuang, Hebei and 1 other locations
- The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
- Peking Union Medical College Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Yuguang Huang, Dr — Peking Union Medical College Hospital
- Study coordinator: Lu Che, Dr
- 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.