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UnknownNCT05146817

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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

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

Conditions

Interventions

TypeNameDescription
OTHEROral careTreatment 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

Timeline

Start date
2021-12-01
Primary completion
2022-09-01
Completion
2022-12-01
First posted
2021-12-07
Last updated
2021-12-07

Locations

1 site across 1 country: Russia

Source: ClinicalTrials.gov record NCT05146817. Inclusion in this directory is not an endorsement.