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NCT Number: NCT04505202

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

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.

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Key information

Conditions

Ventilator Associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Tracheobronchitis

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karabük University Training and Research Hospital

Karabük, Karabük Province, 78050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.12% chlorhexidine gluconate

Drug

The patients included in the experimental group (0.12% chlorhexidine gluconate) will receive 3 times daily oral care

Placebo

Drug

The patients included in the placebo group ( sodium bicarbonate) will receive 3 times daily oral care

Other names: sodium bicarbonate

Primary outcomes

  1. Pathogen colonization change

    Time frame: change from baseline pathogen colonization at Day 3

    We will examine microbiological analyses ( mini-BAL, oropharyngeal and tracheal secretions)

  2. Oral assessment guide score change

    Time frame: 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

  3. Clinical pulmonary infection score change

    Time frame: 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 )

  4. rate of tracheobronchitis change

    Time frame: change from baseline the rate of tracheobronchitis at Day 3

    Questionary (use the rate of tracheobronchitis categories)

Secondary outcomes

  1. cost effectiveness

    Time frame: Day 30

    We used the decision tree modelling for estimating the cost-effectiveness of antiseptic solutions.

  2. Mortality

    Time frame: Day 7 and Day 28

    rate of mortality

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 10, 2020
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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