Oro-nasal Decontamination to Prevent Ventilator-associated Pneumonia

NCT05895773 | Completed Phase 2

• 1 other identifier: 4/2023ANET2
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Beck oral assessment score.

  4,8 and 12 hours after oral hygiene.

• Mechanical ventilation length.

  up to 24 weeks.

• Mortality

  up to 6 months.

• Length of ICU stay.

  up to 24 weeks.

Study Arms (2)

Treatment group

EXPERIMENTAL

Nasal and oropharyngeal Povidone Iodine plus Glycyrrhizin sprays will be applied 4 times daily after tooth cleaning with a brush.

Drug: Povidone-Iodine

Placebo group

PLACEBO COMPARATOR

Nasal and oropharyngeal saline sprays will be applied 4 times daily after teeth cleaning with a brush.

Drug: Saline spray

Interventions

Povidone-Iodine DRUG

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.

Also known as: glycyrrhizic acid

Treatment group

Saline spray DRUG

Normal saline 0.9% as a nasal and oropharyngeal spray (Mint flavored) will be applied 4 times per day.

Also known as: Normal saline

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University hospitals

Shibīn al Kawm, Menoufia, Egypt

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Povidone-Iodine; Glycyrrhizic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Pentacyclic Triterpenes; Triterpenes; Terpenes; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hazem E Elsersy, MD

  Menoufia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the pharmacist is aware of the randomization and preparing the study drugs. The pharmacist will encode the medication bottles and keep the code key confidential until the completion of follow-up of the last patient.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of anesthesia

Model Details: The patients will be randomly allocated using a computer program into two equal groups: the treatment group and the placebo group.

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 9, 2023
• Study Start: June 24, 2023
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• 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

Locations

EG (1)