Oro-nasal Decontamination to Prevent Ventilator-associated Pneumonia

Ventilator Associated Pneumonia Clinical Trial

Official title:

Effect of Nasal and Oropharyngeal Use of Povidone Iodine and Glycyrrhizin on Ventilator-associated Respiratory Infections: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05895773
• Other study ID #: 4/2023ANET2
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 24, 2023
• Est. completion date: November 24, 2023

Study information

• Verified date: November 2023
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: November 24, 2023
• Est. primary completion date: November 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Drug:
• Povidone-Iodine
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.
• Saline spray
Normal saline 0.9% as a nasal and oropharyngeal spray (Mint flavored) will be applied 4 times per day.

Locations

Country	Name	City	State
Egypt	Menoufia University hospitals	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ventilator-associated pneumonia.	Clinical criteria for VAP include the following: worsened or development of new infiltrates in chest radiographs, body temperature less than 35°C or more than 38.5 °C, the leukocytic count below 4000 /mm3 or more than 11000/ mm3, tracheal aspirate of sputum or purulent discharge, and the demand for a positive end-expiratory pressure by more than 20% to keep oxygen saturation above 92% or the need for an increase in the inspired oxygen fraction. Each parameter is given a score of 0, 1, or 2. A score of 6 or more confirms VAP.	every day for 15 days
Secondary	Beck oral assessment score.	Examination of lips, gingiva, oral mucosa, tongue, teeth, and saliva each given 1 to 4 according to severity. a total score of 5 denotes no dysfunction while a score from 16 to 20 indicates severe dysfunction.	4,8 and 12 hours after oral hygiene.
Secondary	Mechanical ventilation length.	Days spent by the patient on the ventilator.	up to 24 weeks.
Secondary	Mortality	Percentage of patients died from VAP.	up to 6 months.
Secondary	Length of ICU stay.	Number of days patients need to be discharged from ICU.	up to 24 weeks.