Oro-nasal Decontamination to Prevent Ventilator-associated Pneumonia
Condition: Ventilator Associated Pneumonia
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      It has been shown that oral hygiene reduces the incidence of ventilator-associated pneumonia
      (VAP). The nasopharynx is considered to be an important source of contaminated micro
      aspiration to the lung however, the effect of nasopharyngeal decontamination on VAP has not
      been yet investigated. The investigators hypothesized that decontamination of oral and
      nasopharyngeal cavities with combined Povidone Iodine and glycyrrhizin would remarkably
      reduce the incidence of VAP.
    

Detailed description: 
      Infections that occur more than 48 hours after intubation are known as ventilator-associated
      pneumonia (VAP) and ventilator-associated tracheobronchitis (VAT). The incidence of VAP in
      mechanically ventilated patients ranges from 8 to 48% with a mortality rate of 24%-76%.

      These infections are a serious problem that Increases the need for prolonged hospitalization,
      antimicrobial therapy, and rising healthcare expenses. As a result, preventing VAP and VAT is
      critical to improving the quality of life by reducing complications in mechanically
      ventilated patients.

      Intubation is a mechanical procedure that Breaks the natural barrier, allowing bacteria to
      colonize. Microorganisms enter the lungs through the lower respiratory tract from the
      oropharynx, the endotracheal tube cuff leaks, or the biofilm in the endotracheal tube. The
      microbial flora in the oral cavities of hospitalized patients, particularly those
      mechanically ventilated, gradually changes; gram-positive bacteria of low virulence
      predominate at admission (Streptococcus spp., Actinomyces spp.) are gradually replaced by
      more virulent gram-negative, potentially pathogenic microbial flora. This change happens on
      mucosal surfaces as well as in dental plaque, which in the physiological state are populated
      by 200-350 different bacterial species. The nasal-oropharyngeal axis involves nasal
      secretions swept to the oropharynx by mucociliary clearance followed by the aspiration of
      infected fluid into the lower airway. Nasal-oropharyngeal axis with subsequent seeding of the
      lungs leads to respiratory disease. The investigators hypothesized that micro aspirates from
      the nasopharynx and oropharynx are substantially contributing to the development of both VAT
      and VAP and the decontamination of the nasal and oral cavity would greatly help in the
      reduction of VAP and VAT. The purpose of this study is to compare the effect of nasal and
      Oro-pharyngeal use of a combination of Povidone Iodine (PVI) and Glycyrrhizin (GA) [treatment
      group] for oral and nasal decontamination on preventing VAP and VAT with the placebo group.
      Another objective is to compare the effect of treatment used for oral care on oral health and
      the prevention of microbial colonization in the mouth with the placebo group.
    

Intervention name(s): Povidone-Iodine; Saline spray
Intervention type(s): Drug; Drug
Intervention description(s): Povidone Iodine 0.5% plus glycyrrhizin acid 2.5 mg/ml as a nasal and an oropharyngeal spray (mint flavored) will be applied 4 times per day.; Normal saline 0.9% as a nasal and oropharyngeal spray (Mint flavored) will be applied 4 times per day.
Other intervention name(s): glycyrrhizic acid; Normal saline
Intervention MeSH terms: Povidone-Iodine; Glycyrrhizic Acid; Povidone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be randomly allocated using a computer program into two equal groups: the treatment group and the placebo group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention