The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia

Northern State Medical University60 enrolled

Overview

Oropharynx is the main source of pathogen microorganisms for the ventilator - associated pneumoniae. As known bacteriophages can eliminate different pathogen microorganisms or reduce a degree of a pathogen's colonization. The research team is considering that oropharyngeal decontamination with bacteriophages can prevent the developing of the ventilator - associated pneumoniae. There will be three groups in this investigation: placebo, antiseptic drug (Octenisept) and bacteriophage (Sexthaphag).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Trauma Injury Brain Injuries Abdominal Sepsis Pancreatitis Meningitis

Interventions

ControlDRUG

Oropharyngeal decontamination with saline will be performing three time a day every 8 hours during mechanical ventilation

Antiseptic SolutionDRUG

Oropharyngeal decontamination with antiseptic solution will be performing three time a day every 8 hours during mechanical ventilation

BacteriophageDRUG

Oropharyngeal decontamination with bacteriophage will be performing three time a day every 8 hours during mechanical ventilation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- invasive mechanical ventilation beyond 48 hours Exclusion Criteria: * hospital - acquired pneumonia * community - acquired pneumoniae * BMI \> 35 kg/cm2 * pregnancy * tracheostomy * reintubation

Outcomes

Primary Outcomes

Incidence of ventilator-associated pneumonia (VAP)

CPIS is using for diagnosis the VAP, if CPIS equal or more 6, the VAP will be confirmed

Time frame: Change from Baseline CPIS at 14 days

Changing of oral and lung microbiomes

Microbiology researching samples from oral cavity and trachea. The Gram positive and Gram negative aerobes and anaerobes will be assessed with observing Colony Form Unit

Time frame: Change from Baseline Microbiology researching at 14 days

Secondary Outcomes

Organ dysfunction

Sequential Organ Function Assessment (SOFA) will be using for assessment organ dysfunction Patient examination with Sequential Organ Function Assessment (SOFA). If Sequential Organ Function Assessment more then 2 points Organ dysfunction is present. The hirher value is equal worse outcome

Time frame: Change from Baseline Sequential Organ Function Assessment at 14 days

Concentration of C - reactive protein (CRP)

Biomarker of the VAP

Time frame: Change from Baseline CRP at 14 days

Concentration of Procalcitonin (PCT)

Biomarker of the VAP

Time frame: Change from Baseline PCT at 14 days

Rate of Mortality

Mortality for 28 days of a hospitalization

Time frame: Change from Baseline PCT at 28 days