Clinical trial NCT06966817: The Effect of Two Different Oral Care Solutions on Ventilator-Associated Pneumonia and Oral Health of Mechanically Ventilated Patients in the Intensive Care Unit
Official title: The Effect of Two Different Oral Care Solutions on Ventilator-Associated Pneumonia and Oral Health of Mechanically Ventilated Patients in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Ventilator-associated Pneumonia and Oral Health
Keywords: ventilator-associated pneumonia , oral health
ventilator-associated pneumonia ,oral health
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Before starting the study, the purpose of this study was explained to all nurses working in the intensive care unit and a 1-hour training was given about the study. The content of this training included theoretical information for nurses and guidance on the correct application of the oral care protocol. After the oral care application protocol in the intensive care unit was effectively implemented by the nurses, the data collection phase of the study was started.

After the compliance of the patients admitted to the intensive care unit with the study inclusion criteria was evaluated, the oral care protocol to be applied to the patients was explained to the relatives of the patients included in the study and written and verbal consents were obtained.
Primary purpose: PREVENTION

Brief summary: The aim of this observational study is to evaluate the effects of two different oral care solutions on ventilator-associated pneumonia and oral health in mechanically ventilated participants in the intensive care unit.

Did oral health improve in participants who used cetylpyridinium chloride? Did pneumonia develop? Did oral health improve in participants who used chlorhexidine chloride? Did pneumonia develop? The results will be evaluated by giving oral care to the participants with these solutions for 5 days with the same protocol.

Detailed description: Ventilator-associated pneumonia (VAP) is defined as pulmonary parenchymal infection in patients exposed to invasive mechanical ventilation for at least 48 hours and is a part of intensive care unit (ICU)-acquired pneumonia. Ventilator-associated pneumonia is the most common intensive care unit (ICU)-acquired infection among patients receiving invasive mechanical ventilation. When the VAP data of surgical and medical ICUs of thirty-six developing countries, including our country, for the years 2013-2018 were evaluated; the average VAP rate was determined as 11.47 per 1000 ventilator days. It contributes to the increase in hospital mortality, MV and ICU hospital stay. Therefore, it worsens the condition of the critically ill patient and increases the total hospitalization cost. It has become mandatory to take preventive measures to ensure control and reduce the incidence of VAP. Preventive strategies to prevent the development of pneumonia in ventilated patients are based on the implementation of infection control, i.e., avoiding prolonged ventilation with adequate sedation and weaning protocols, avoiding biofilm formation on the endotracheal tube and microaspiration of subglottic secretions, avoiding bacterial translocation from the stomach to the upper airway, and avoiding oropharyngeal colonization. Lack of effective oral hygiene results in the development of dental plaque deposits on the teeth within 72 hours, which can be reservoirs for potential respiratory pathogens. Bacteria present in plaque serve as a reservoir for potential pathogens that can enter the respiratory tract. Because of this potential for infection, oral hygiene is important in patients receiving mechanical ventilation. Keeping a patient's mouth clean and disease-free (oral hygiene) can help prevent VAP. Mouthwashes have been recommended as a regular oral care because they can reduce costs and reduce plaque formation. The type, concentration, dose, and frequency of use of the rinse may also affect antibacterial efficacy. There remains uncertainty regarding the most effective protocols, including the types of personnel involved, frequency of oral care, whether antiseptics should be used, and if so, what type of antiseptic to use (e.g., chlorhexidine gluconate, sodium bicarbonate, hydrogen peroxide, cetylpyridinium chloride, povidone-iodine). Currently, the Centers for Disease Control and Prevention (CDC) recommends oral hygiene with 0.12% chlorhexidine (CHX) during the perioperative period of cardiac surgery, but there are no recommendations for its routine use in the prevention of nosocomial pneumonia in critically ill patients. Cetylpyridinium chloride (CPC) is a broad-spectrum antimicrobial agent that has been shown to be effective in reducing dental plaque and preventing gingivitis. Cetylpyridinium chloride 0.05% has been used as an alternative to reduce dental plaque and gingivitis in patients who develop mucosal irritation and stains due to CHX.

In light of all this information, oral care is one of the most important treatments for mechanically ventilated patients in the intensive care unit. It supports the treatment of intensive care patients and can prevent respiratory tract infections. For this reason, it is important to determine the effectiveness of oral care solutions used in patients and their effects on ventilator-associated pneumonia.

The aim of this study is to evaluate the effects of two different oral care solutions on ventilator-associated pneumonia and oral health of patients on mechanical ventilation in the intensive care unit.

H0: There is no difference between the development of VAP and oral health of patients on mechanical ventilation in the intensive care unit where 0.25% chlorhexidine gluconate is used in oral care and the development of VAP and oral health of patients on mechanical ventilation in the intensive care unit where 0.05% cetylpyridinium chloride is used in oral care.

H1: There is a difference between the development of VAP and oral health of patients on mechanical ventilation in the intensive care unit where 0.25% chlorhexidine gluconate is used in oral care and the development of VAP and oral health of patients on VAP and oral health of patients on oral care who 0.05% cetylpyridinium chloride is used in oral care.

Eligibility criteria: Inclusion Criteria:• Being 18 years of age or older

* Requiring mechanical ventilation for at least 48 hours
* Not having a diagnosis of aspiration pneumonia
* Having a Clinical Lung Infection Score (CPIS) \<6 on the first day
* Not having a diagnosis of pneumonia or COVID
* Not having facial or oral trauma
* Being within the first 24 hours of the intubation process
* Not having a medical impediment to elevating the head of the bed 30o

Exclusion Criteria:

* Not accepting to participate in the study
* Termination of MV support for less than 48 hours
* Being allergic to any of the solutions to be used in oral care
* Being diagnosed with immunodeficiency
* Having thrombocytopenia, leukopenia and oral aphthae, stomatitis, candidiasis, gingivitis
* Using immunosuppressive drugs

Primary outcomes:
measure: EFFECTS OF TWO DIFFERENT ORAL CARE SOLUTIONS ON VENTILATOR-ASSOCIATED PNEUMONIA AND ORAL HEALTH OF PATIENTS CONNECTED TO MECHANICAL VENTILATORS IN THE INTENSIVE CARE UNIT
timeFrame: from registration until the end of the 5th day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: bediye öztaş
role: PRINCIPAL_INVESTIGATOR
References: