Oro-nasal Decontamination to Prevent Ventilator-associated Pneumonia

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

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.

Study Overview

• Status: Completed
• Conditions: Ventilator Associated Pneumonia
• Intervention / Treatment: Drug: Povidone-Iodine; Drug: Saline spray

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt
      • Menoufia University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Nasal and oropharyngeal Povidone Iodine plus Glycyrrhizin sprays will be applied 4 times daily after tooth cleaning with a brush.	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.; Other Names: glycyrrhizic acid
Placebo Comparator: Placebo group; Nasal and oropharyngeal saline sprays will be applied 4 times daily after teeth cleaning with a brush.	Drug: Saline spray; Normal saline 0.9% as a nasal and oropharyngeal spray (Mint flavored) will be applied 4 times per day.; Other Names: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Mechanical ventilation length.	Days spent by the patient on the ventilator.	up to 24 weeks.
Mortality	Percentage of patients died from VAP.	up to 6 months.
Length of ICU stay.	Number of days patients need to be discharged from ICU.	up to 24 weeks.

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: Hazem E Elsersy, MD, Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2023
• Primary Completion (Actual): November 24, 2023
• Study Completion (Actual): November 24, 2023

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Inflammatory Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone; Glycyrrhizic Acid
• Other Study ID Numbers: 4/2023ANET2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: access criteria will be open for researchers, all data will be released except for personal identification for patients. To request data please contact the principal investigator e-mail. hazelsersy@hotmail.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No