Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID05971810

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

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

Eligible

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
Not Eligible

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

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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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Published Research Related To This Trial

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.

Jiawen Yu, Lu Che, Qianmei Zhu...

https://pubmed.ncbi.nlm.nih.gov/40374210
Perioperative Oral Decontamination and Immunonutrition to Prevent Lung Complications in Elderly Patients Undergoing Elective Non-Cardiac Surgery A Multicenter Randomized Controlled Trial | DecenTrialz