Perioperative Oral Decontamination and ImmunoNuTrition (POINT) on Postoperative Pulmonary Complications in Elderly: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 592
- 试验地点
- 2
- 主要终点
- postoperative pulmonary complications
研究概览
简要总结
The goal of this multicenter randomized controlled trial is to explore the efficacy of perioperative oral decontamination and immunonutrition supplement to prevent postoperative pulmonary complications in elderly patients(≥65 years) receiving elective non-cardiac operations. Participants will be either given immunonutrition supplement versus routine nutrition advice, and oral chlorhexidine decontamination versus routine oral care randomly. The two interventions will be compared with control groups separately regarding postoperative pulmonary complications and other outcomes.
详细描述
This study is a prospective, multicenter, two-by-two factorial randomized controlled trial evaluating the efficacy of immunonutrition supplementation and oral chlorhexidine decontamination. Patients aged 65 years and older who are scheduled for elective non-cardiac surgeries will be recruited. Participants will be excluded if they have contraindication to the intervention. The patients will be randomized into four groups in 1:1:1:1 ratio (oral decontamination vs routine oral care, immunonutrition supplementation vs routine nutrition advice). The primary outcome is the incidence of postoperative pulmonary complications within 7 days after surgery. Secondary outcomes include incidence of pneumonia, infectious complications, comprehensive complication index, postoperative functional recovery, length of hospital stay and hospital expense.
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 major non-cardiac surgery;
- •scheduled for general anesthesia and endotracheal intubation;
- •American Society of Anesthesiologists (ASA) physical status classification I-IV;
- •with intermediate to high risk of respiratory complications assessed by Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score;
- •informed 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 in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. 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: immunonutrition supplement of ORAL IMPACT™ (Dietary Supplement)
Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)
Patients in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. 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 (Other)
Group B (immunonutrition and routine oral care, IN&RC)
Patients in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. For oral health care, they will receive routine oral care which is routine toothbrushing twice daily.
干预措施: immunonutrition supplement of ORAL IMPACT™ (Dietary Supplement)
Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)
Patients in this group 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. They 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 (Other)
Group D (routine nutrition advice and routine oral care, RN&RC)
Patients in this group 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. They will also receive routine oral care which is routine toothbrushing twice daily.
结局指标
主要结局
postoperative pulmonary complications
时间窗: within 7 days after surgery
composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc.
次要结局
- postoperative pneumonia(within 7days and 30 days after surgery)
- postoperative infectious complications(within 7days and 30 days after surgery)
- postoperative recovery(within 7days and 30 days after surgery)
- hospitalization expenses(upon hospital discharge, typically 1-2 weeks)
- postoperative complications(within 7days and 30 days after surgery)
- postoperative pulmonary complications(within 30 days after surgery)
- length of hospital stay(upon hospital discharge，typically 1-2 weeks)