Clinical trial NCT05971810: Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly
Official title: Perioperative Oral Decontamination and ImmunoNuTrition (POINT) on Postoperative Pulmonary Complications in Elderly: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Complications
Pulmonary Complication
Keywords: immunonutrition
oral decontamination
postoperative pulmonary complications
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Fujian Provincial Hospital
name: The Second Hospital of Hebei Medical University
name: Shenzhen Qianhai Shekou Free Trade Zone Hospital
name: Ningbo No.2 Hospital
name: Peking University International Hospital
name: Guizhou Provincial People's Hospital
First posted: 2023-08-02
Enrollment: 592
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: postoperative pulmonary complications
timeFrame: within 7 days after surgery
Secondary outcomes:
measure: postoperative pneumonia
timeFrame: within 7days and 30 days after surgery
measure: postoperative pulmonary complications
timeFrame: within 30 days after surgery
measure: postoperative infectious complications
timeFrame: within 7days and 30 days after surgery
measure: postoperative complications
timeFrame: within 7days and 30 days after surgery
measure: postoperative recovery
timeFrame: within 7days and 30 days after surgery
measure: hospitalization expenses
timeFrame: upon hospital discharge, typically 1-2 weeks
measure: length of hospital stay
timeFrame: upon hospital discharge，typically 1-2 weeks
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Peking
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yuguang Huang, Dr
role: PRINCIPAL_INVESTIGATOR
References: