Original Protocol of Oral Cavity Care During Long-term Mechanical Ventilation

Study Overview
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Brief Summary
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This is a prospective open label randomized controlled trial of the efficacy of original oral care protocol for prevention of ventilator-associated pneumonia (VAP) and ventilator-associated tracheobronchitis (VAT)in adult patients mechanically ventilated for at least 3 days

Detailed Description
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The study aims to clarify the effect of of the original method of oral cavity care in adult patients of intensive care units on long-term mechanical ventilation due to the assessment of the microbiological landscape of the oral cavity, oral plaque, upper and lower respiratory tract, the incidence of ventilator-associated pneumonia (VAP) and ventilator-associated tracheobronchitis (VAT) , depending on the traditional or original protocol of the oral cavity care. Ventilator associated pneumonia is associated with significant morbidity and mortality.Inadequate oral hygiene in intensive care units (ICUs) has been recognized as a critical issue, for it is an important risk factor for ventilator associated pneumonia (VAP). VAP is an aspiration pneumonia that occurs in mechanically ventilated patients, mostly caused by bacteria colonizing the oral cavity and dental plaque. It has been suggested that improvement of oral hygiene in ICU patients could lead to a reduced incidence of VAP. Although diverse oral care measures for ICU patients have been proposed in the literature, there is no evidence that could identify the most efficient ones. Although there are several evidence-based protocols, oral care measures are still performed inconsistently and differ greatly between individual ICUs.The influence of tooth brushing to maintain good oral health in the general population has long been standard practice. However the effect of brushing in the mechanically ventilated and intubated critically ill patients to dislodge organisms from dental plaque remains largely unclear

Official Title
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Original Protocol of Oral Cavity Care During Long-term Mechanical Ventilation : Microbiological and Clinical Effects

Conditions
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Adult Patients of Intensive Care Units on Long-term Lung Mechanical Ventilation

Intervention / Treatment
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* Other: Oral care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 years or more; Mechanical ventilation more than 24 hours; Expected length of mechanical ventialtion more than 72 hours; Exclusion Criteria: Aspiration at the prehospital stage Community-acquired pneumonia COPD or specific lung diseases Сhest Injury Hemo and \or pneumothorax Fat embolism Lung cancer Severe renal and\or hepatic impairment Blood platelets less than 50 000 / μl Pregnancy and the period of breastfeeding; Other circumstances that the researcher considers inappropriate to participate in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison of 2 patients' groups to assess the efficiency of the method of ventilator-associated infections prevention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional oral care in long-term mechanical ventilation ICU patients<br>Control group - traditional protocol of oral care ( traditional tooth brushing 1 time a day + chlorhexidine rinsing | Other: Oral care<br>* Treatment group - original protocol of oral care: special device for tooth brushing 3 times a day with chlorhexidine . Control group - traditional protocol of oral care ( traditional tooth brushing 1 time a day + chlorhexidine rinsing<br>|
| Experimental: Original oral care protocol in long-term mechanical ventilation ICU patients<br>Treatment group - original protocol of oral care: special device for tooth brushing 3 times a day with chlorhexidine . | Other: Oral care<br>* Treatment group - original protocol of oral care: special device for tooth brushing 3 times a day with chlorhexidine . Control group - traditional protocol of oral care ( traditional tooth brushing 1 time a day + chlorhexidine rinsing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial growtn | Oral and tracheal microbial growth/inhibition | 14 days |