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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
592
For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery.
For intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery.
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGPeking Union Medical College Hospital
Beijing, China
RECRUITINGpostoperative pulmonary complications
composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc.
Time frame: within 7 days after surgery
postoperative pneumonia
defined according to the US Centers for Disease Control Definition
Time frame: within 7days and 30 days after surgery
postoperative pulmonary complications
composite outcome of postoperative pulmonary complications, including pneumonia, atelectasis, pneumothorax, bronchospasm, pleural effusion, hypoxemia, acute respiratory failure, prolonged mechanical ventilation, unplanned re-intubation,etc.
Time frame: within 30 days after surgery
postoperative infectious complications
composite outcome including surgical site infection, respiratory infection, urinary tract infection, intra-abdominal infection, blood stream infection, etc.
Time frame: within 7days and 30 days after surgery
postoperative complications
defined using comprehensive complication index
Time frame: within 7days and 30 days after surgery
postoperative recovery
assessed by 15-item quality of recovery questionnaire and WHO disability assessment schedule 2.0
Time frame: within 7days and 30 days after surgery
hospitalization expenses
total expense during the hospital stay
Time frame: upon hospital discharge, typically 1-2 weeks
length of hospital stay
days of in hospital stay
Time frame: upon hospital discharge,typically 1-2 weeks
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