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

NCT ID: NCT05146817

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2022-12-31

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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison of 2 patients' groups to assess the efficiency of the method of ventilator-associated infections prevention
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Traditional oral care in long-term mechanical ventilation ICU patients

Control group - traditional protocol of oral care ( traditional tooth brushing 1 time a day + chlorhexidine rinsing

Group Type ACTIVE_COMPARATOR

Oral care

Intervention Type OTHER

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

Original oral care protocol in long-term mechanical ventilation ICU patients

Treatment group - original protocol of oral care: special device for tooth brushing 3 times a day with chlorhexidine .

Group Type EXPERIMENTAL

Oral care

Intervention Type OTHER

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

Interventions

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Oral care

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age of 18 years or more;
2. Mechanical ventilation more than 24 hours;
3. Expected length of mechanical ventialtion more than 72 hours;

Exclusion Criteria

1. Aspiration at the prehospital stage
2. Community-acquired pneumonia
3. COPD or specific lung diseases
4. Сhest Injury
5. Hemo and \\or pneumothorax
6. Fat embolism
7. Lung cancer
8. Severe renal and\\or hepatic impairment
9. Blood platelets less than 50 000 / μl
10. Pregnancy and the period of breastfeeding;
11. Other circumstances that the researcher considers inappropriate to participate in this study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Federal North-West Medical Research Centre

Saint Petersburg, , Russia

Site Status

Countries

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Russia

Other Identifiers

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IS-0921

Identifier Type: -

Identifier Source: org_study_id