Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly

Last updated: January 25, 2025
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

immunonutrition supplement of ORAL IMPACT™

oral chlorhexidine decontamination

Clinical Study ID

NCT05971810
I-23PJ953
  • Ages > 65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 AssessRespiratory Risk in Surgical Patients in Catalonia (ARISCAT) score;

  6. informed consent obtained.

Exclusion

Exclusion Criteria:

  1. emergency surgery;

  2. preoperative pneumonia;

  3. allergic to chlorhexidine;

  4. severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmunediseases, taking immunosuppressant or immunoregulation medications, or with othercontraindication to immunonutrition supplementation;

  5. expected intervention of immunonutrition<3 days.

Study Design

Total Participants: 592
Treatment Group(s): 2
Primary Treatment: immunonutrition supplement of ORAL IMPACT™
Phase:
Study Start date:
August 23, 2023
Estimated Completion Date:
September 01, 2025

Study 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.

Connect with a study center

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Peking,
    China

    Active - Recruiting

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