Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT05971810

Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly

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

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.

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

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

PREVENTION

Number of Arms

4

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Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly | DecenTrialz