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

NCT ID: NCT05146817

Last Updated: 2021-12-07

Basic Information

• 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

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

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

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

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Federal North-West Medical Research Centre

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

IS-0921

Identifier Type: -

Identifier Source: org_study_id