Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications

Not Applicable

Completed

• Conditions: Ventilator Associated Pneumonia; Tracheobronchitis
• Interventions: Drug: 0.12% chlorhexidine gluconate; Drug: Placebo

• Registration Number: NCT04505202
• Lead Sponsor: Karabuk University

Brief Summary

Ventilator-associated pneumonia and ventilator-associated treakeabronchitis in respiratory tract infections associated with ventilator are common infections in intensive care unit and cause significant morbidity, mortality and health expenditures in nosocomial infections. Adequate and effective oral care by nurses in intensive care patients, possible complications, intensive care unit stay in the intensive care unit and is very important in terms of mortality.

Detailed Description

The aim of this study will (1) evaluate the effect of 0.12% chlorhexidine gluconate on ventilator-associated pneumonia, ventilator-associated treakeabronchitis, (2) determine the effect of preventing microorganism colonization, and (3) assess the mortality rate for each patient and the cost-effectiveness in the health expenditures.

Study Timeline

• Study Start: 2019-04-15
• Primary Completion: 2020-03-03
• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-10
• Study Completion: 2020-09-03
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Age ≥ 18 years
• Admission in critical care with in 24 hours
• Having an endotracheal tube

Exclusion Criteria

• History of chlorhexidine allergy
• Duration of mechanichal ventilation less than 48 h
• Confirmed diagnosis of pneumonitis before admission in the ICU
• Transfer from another ICU
• Receiving chemotherapy or radiotherapy
• Patients with immunodeficiency
• Patients with tracheostomies
• Required specific oral hygiene procedures
• Facio-maxillary or dental trauma/surgery
• Being pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	0.12% chlorhexidine gluconate	0.12% chlorhexidine gluconate
Placebo group	Placebo	sodium bicarbonate

Primary Outcome Measures

Name	Time	Method
Pathogen colonization change	change from baseline pathogen colonization at Day 3	We will examine microbiological analyses ( mini-BAL, oropharyngeal and tracheal secretions)
rate of tracheobronchitis change	change from baseline the rate of tracheobronchitis at Day 3	Questionary (use the rate of tracheobronchitis categories)
Oral assessment guide score change	at the time of admission into the study (day 0), at study day 2 and at day 3	The score ranges from 8 to 24 and higher scores indicating worse oral health
Clinical pulmonary infection score change	at the time of admission into the study (day 0), at study day 2 and at day 3	The score ranges from 0 to 12 (ventilator-associated pneumonia ≥ 6 )

Secondary Outcome Measures

Name	Time	Method
Mortality	Day 7 and Day 28	rate of mortality
cost effectiveness	Day 30	We used the decision tree modelling for estimating the cost-effectiveness of antiseptic solutions.

Trial Locations

Locations (1)

Karabük University Training and Research Hospital; 🇹🇷 Karabük, Karabuk, Turkey