Effect of Perioperative Immunonutrition Intervention and Oral Decontamination on Postoperative Complications in Elderly: a Prospective Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• age≥65 years;
• undergoing non-cardiac surgery (expected duration \>2 hours);
• scheduled for general anesthesia and endotracheal intubation;
• ASA classification I-IV;
• with intermediate to high risk of respiratory complications assessed by ARISCAT score (Assess Respiratory Risk in Surgical Patients in Catalonia);
• inform consent obtained
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Lu Che, MD
tracymaobao@126.com
69152020
Backup
Jiawen Yu, MD
jiawen_yu@foxmail.com
69152020
Time Frame
Start Date: 2023-02-06
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 590
Treatments
Experimental: Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)
Patients will receive immunonutrition supplement of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery and oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.
Experimental: Group B (immunonutrition and routine oral care, IN&RC)
Patients will receive immunonutrition supplement of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery and routine oral care.
Experimental: Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)
Patients 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. Patients will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.
No_intervention: Group D (routine nutrition advice and routine oral care, RN&RC)
Patients will be advised to follow a standard nutrition advice and routine oral care.
Related Therapeutic Areas
Sponsors
Leads: Huang YuGuang