0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia

Overview

Chlorhexidine is a effective strategy in reducing ventilator associated pneumonia. However, it is unclear if prophylactic 0.12% chlorhexidine oral rinse can reduce the risk of non-ventilator hospital-acquired pneumonia among hospitalized patients.

Full Title of Study: “Effect of 0.12% Chlorhexidine Oral Care for the Prevention of Non-ventilator Hospital-acquired Pneumonia Among Hospitalized Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 31, 2020

Detailed Description

Participants will be classified into three groups, applied twice a day by care givers. Oral colonization will be tested in the baseline, day-3, day-7, and at the discharge. Quantitation of colonization of the oral cavity by oral rinses and respiratory pathogens were measured.

Interventions

  • Drug: 0.12% Chlorhexidine Oral Liquid Product
    • The intervention group 1 received 10ml 0.12% chlorhexidine solution for oral rinse twice a day.
  • Drug: Listerine Oral Liquid Product
    • The intervention group 2 received 10ml Listerine solution for oral rinse twice a day.
  • Other: Normal Saline Product
    • The control group received 10ml normal saline for oral rinse twice a day.

Arms, Groups and Cohorts

  • Experimental: 0.12% chlorhexidine
    • Participants will be randomized to Chlorhexidine solution group, applied twice a day by care givers.
  • Sham Comparator: Listerine
    • Participants will be randomized to Listerine solution group, applied twice a day by care givers.
  • Placebo Comparator: Normal saline
    • Participants will be randomized to Normal saline group, applied twice a day by care givers.

Clinical Trial Outcome Measures

Primary Measures

  • oral bacterial colonization status
    • Time Frame: 1 year

Secondary Measures

  • The rate of non-ventilator associated pneumonia
    • Time Frame: 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • Hospitalized patients > 20 years old without ventilator Exclusion Criteria:

  • known hypersensitivity to or intolerance of Chlorhexidine or Listerine

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Cheng-Kung University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chen, Yen-Chin, Vice Head Nurse and Clinical Assistant Professor – National Cheng-Kung University Hospital

References

Sangmuang P, Lucksiri A, Katip W. Factors Associated with Mortality in Immunocompetent Patients with Hospital-acquired Pneumonia. J Glob Infect Dis. 2019 Jan-Mar;11(1):13-18. doi: 10.4103/jgid.jgid_33_18.

Giuliano KK, Baker D, Quinn B. The epidemiology of nonventilator hospital-acquired pneumonia in the United States. Am J Infect Control. 2018 Mar;46(3):322-327. doi: 10.1016/j.ajic.2017.09.005. Epub 2017 Oct 16.

Quinn B, Baker DL, Cohen S, Stewart JL, Lima CA, Parise C. Basic nursing care to prevent nonventilator hospital-acquired pneumonia. J Nurs Scholarsh. 2014 Jan;46(1):11-9. doi: 10.1111/jnu.12050. Epub 2013 Sep 30.

Chou CC, Shen CF, Chen SJ, Chen HM, Wang YC, Chang WS, Chang YT, Chen WY, Huang CY, Kuo CC, Li MC, Lin JF, Lin SP, Ting SW, Weng TC, Wu PS, Wu UI, Lin PC, Lee SS, Chen YS, Liu YC, Chuang YC, Yu CJ, Huang LM, Lin MC; Infectious Diseases Society of Taiwan;; Taiwan Society of Pulmonary and Critical Care Medicine,; Medical Foundation in Memory of Dr. Deh-Lin Cheng;; Foundation of Professor Wei-Chuan Hsieh for Infectious Diseases Research and Education;; CY Lee's Research Foundation for Pediatric Infectious Diseases and Vaccines,; 4th Guidelines Recommendations for Evidence-based Antimicrobial agents use in Taiwan (GREAT) working group. Recommendations and guidelines for the treatment of pneumonia in Taiwan. J Microbiol Immunol Infect. 2019 Feb;52(1):172-199. doi: 10.1016/j.jmii.2018.11.004. Epub 2018 Dec 6.

Zhang J, Ab Malik N, McGrath C, Lam O. The effect of antiseptic oral sprays on dental plaque and gingival inflammation: A systematic review and meta-analysis. Int J Dent Hyg. 2019 Feb;17(1):16-26. doi: 10.1111/idh.12331. Epub 2018 Feb 6.

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