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

NCT05146817 | Unknown

• 1 other identifier: IS-0921
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Microbial growtn

  Oral and tracheal microbial growth/inhibition

  14 days

Study Arms (2)

Traditional oral care in long-term mechanical ventilation ICU patients

ACTIVE COMPARATOR

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

Other: Oral care

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

EXPERIMENTAL

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

Other: Oral care

Interventions

Oral care 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; Traditional oral care in long-term mechanical ventilation ICU patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years or more;
• Mechanical ventilation more than 24 hours;
• Expected length of mechanical ventialtion more than 72 hours;

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Federal North-West Medical Research Centre

Saint Petersburg, 197341, Russia

Location

MeSH Terms

Interventions

Dental Care Team

Intervention Hierarchy (Ancestors)

Patient Care Team; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of 2 patients' groups to assess the efficiency of the method of ventilator-associated infections prevention

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 7, 2021
• Study Start: December 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 7, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)