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

Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications in Patients With Mechanical Ventilation

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.

Study Overview

• Status: Completed
• Conditions: Ventilator Associated Pneumonia; Tracheobronchitis
• Intervention / Treatment: Drug: 0.12% chlorhexidine gluconate; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karabuk
    • Karabük, Karabuk, Turkey, 78050
      • Karabük University Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 0.12% chlorhexidine gluconate	Drug: 0.12% chlorhexidine gluconate; The patients included in the experimental group (0.12% chlorhexidine gluconate) will receive 3 times daily oral care
Placebo Comparator: Placebo group; sodium bicarbonate	Drug: Placebo; The patients included in the placebo group ( sodium bicarbonate) will receive 3 times daily oral care; Other Names: sodium bicarbonate

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karabuk University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): March 3, 2020
• Study Completion (Actual): September 3, 2020

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 2091

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No