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

Ventilator Associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04505202
• Other study ID #: 2091
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: September 3, 2020

Study information

• Verified date: October 2020
• Source: Karabuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 3, 2020
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Tracheobronchitis
• Ventilator Associated Pneumonia

Intervention

Drug:
• 0.12% chlorhexidine gluconate
The patients included in the experimental group (0.12% chlorhexidine gluconate) will receive 3 times daily oral care
• Placebo
The patients included in the placebo group ( sodium bicarbonate) will receive 3 times daily oral care

Locations

Country	Name	City	State
Turkey	Karabük University Training and Research Hospital	Karabük	Karabuk

Sponsors (1)

Lead Sponsor	Collaborator
Karabuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathogen colonization change	We will examine microbiological analyses ( mini-BAL, oropharyngeal and tracheal secretions)	change from baseline pathogen colonization at Day 3
Primary	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
Primary	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
Primary	rate of tracheobronchitis change	Questionary (use the rate of tracheobronchitis categories)	change from baseline the rate of tracheobronchitis at Day 3
Secondary	cost effectiveness	We used the decision tree modelling for estimating the cost-effectiveness of antiseptic solutions.	Day 30
Secondary	Mortality	rate of mortality	Day 7 and Day 28