Clinical trial NCT05895773: Oro-nasal Decontamination to Prevent Ventilator-associated Pneumonia
Official title: Effect of Nasal and Oropharyngeal Use of Povidone Iodine and Glycyrrhizin on Ventilator-associated Respiratory Infections: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ventilator Associated Pneumonia
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be randomly allocated using a computer program into two equal groups: the treatment group and the placebo group.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* on mechanical ventilation less than 24 h after admission and expected to continue mechanical ventilation for more than 72h.

Exclusion Criteria:

* Exclusion criteria include immunosuppression, aspiration pneumonia, all types of pneumonia, sepsis and septic shock, tracheostomy, and pregnancy.

Primary outcomes:
measure: ventilator-associated pneumonia.
timeFrame: every day for 15 days
Secondary outcomes:
measure: Beck oral assessment score.
timeFrame: 4,8 and 12 hours after oral hygiene.
measure: Mechanical ventilation length.
timeFrame: up to 24 weeks.
measure: Mortality
timeFrame: up to 6 months.
measure: Length of ICU stay.
timeFrame: up to 24 weeks.
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University hospitals
state: Menoufia
Study officials:
affiliation: Menoufia University
name: Hazem E Elsersy, MD
role: PRINCIPAL_INVESTIGATOR
References: