Effect of Perioperative Immunonutrition Intervention and Oral Decontamination on Postoperative Complications in Elderly: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 590
- 试验地点
- 1
- 主要终点
- postoperative pulmonary complications
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •emergency surgery;
- •preoperative pneumonia;
- •allergic to chlorhexidine;
- •severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases, taking immunosuppressant or immunoregulation medications, or with other contraindication to immunonutrition supplementation;
- •expected intervention of immunonutrition<3 days.
研究组 & 干预措施
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.
干预措施: immunonutrition (Dietary Supplement)
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.
干预措施: oral chlorhexidine decontamination (Behavioral)
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.
干预措施: immunonutrition (Dietary Supplement)
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.
干预措施: oral chlorhexidine decontamination (Behavioral)
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.
结局指标
主要结局
postoperative pulmonary complications
时间窗: within 7 days after surgery
evaluated by trained investigator
次要结局
- postoperative pneumonia(within 7 days after surgery)
- Comprehensive complication index (CCI)(within 30 days after surgery)
- postoperative recovery(within 30 days after surgery)
- Length of hospital stay(From date of surgery until discharge day, assessed up to 4 weeks)
研究者
Huang YuGuang
Professor
Peking Union Medical College Hospital