Perioperative Oral Decontamination and Immunonutrition to Prevent Lung Complications
in Elderly Patients Undergoing Elective Non-Cardiac Surgery
A Multicenter Randomized Controlled Trial
Led by Peking Union Medical College Hospital · Updated on 2025-01-28
592
Participants Needed
2
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
Official Title
Who Can Participate
AI-Screening
Trial Site Locations
Research Team
How is the study designed?
Frequently Asked Questions
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
F
Fujian Provincial Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of oral decontamination and immunonutrition supplements on preventing lung complications after surgery in elderly patients aged 65 years and older. This multicenter randomized controlled trial focuses on individuals undergoing elective non-cardiac surgeries under general anesthesia. The study aims to compare these two interventions against standard care to see if they reduce postoperative pulmonary complications and other related outcomes.
Participants will be randomly assigned to one of four groups: receiving immunonutrition supplements or routine nutrition advice, and using oral chlorhexidine rinse or routine oral care. The immunonutrition supplement, ORAL IMPACT™, will be taken from recruitment until the day before surgery. The oral chlorhexidine rinse (0.12%) will be used twice daily starting the day before surgery until three days after surgery. The trial will assess each intervention separately regarding their impact on postoperative lung complications.
Throughout the study, participants will be monitored for pulmonary complications within seven days after surgery, including pneumonia and other infections. Researchers will also evaluate overall recovery, hospital stay length, and healthcare costs. The study includes assessments of patient health status before surgery and follow-up during the hospital stay to gather comprehensive data on safety and effectiveness.
CONDITIONS
Official Title
Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly
Who Can Participate
Age: 65Years +
All Genders
Eligibility Criteria
You may qualify if you...
Age 65 years or older
Undergoing major non-cardiac surgery
Scheduled for general anesthesia and endotracheal intubation
American Society of Anesthesiologists (ASA) physical status classification I-IV
Intermediate to high risk of respiratory complications assessed by ARISCAT score
Provided informed consent
You will not qualify if you...
Emergency surgery
Preoperative pneumonia
Allergy to chlorhexidine
Severe liver or kidney dysfunction
Unable to feed orally
Autoimmune diseases
Taking immunosuppressant or immunoregulation medications
Other contraindications to immunonutrition supplementation
Expected immunonutrition intervention less than 3 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 2 locations
1
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
2
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
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Research Team
L
Lu Che, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
4
Frequently Asked Questions
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Perioperative Oral decontamination and ImmunoNuTrition (POINT) to prevent postoperative pulmonary complications in elderly patients scheduled for elective non-cardiac surgeries: protocol for a multicentre, randomised controlled trial.
Perioperative Oral Decontamination and Immunonutrition to Prevent Lung Complications
in Elderly Patients Undergoing Elective Non-Cardiac Surgery
A Multicenter Randomized Controlled Trial | DecenTrialz