Oral Care Layered Enhancement for Improved Oral Hygiene in Intensive Care Units
- Conditions
- Oral Hygiene, Oral HealthVAP - Ventilator Associated PneumoniaMechanical VentilationInfection PreventionOral Care
- Registration Number
- NCT07129733
- Lead Sponsor
- Hospital do Coracao
- Brief Summary
The goal of the ORACLE study is to evaluate the impact of implementing a standardized oral hygiene bundle on outcomes in critically ill, mechanically ventilated patients. The primary objective is to determine whether this bundle can increase the number of ventilator-free days compared to the standard of care.
- Detailed Description
The use of invasive mechanical ventilation (IMV) as an organ support measure is common in intensive care units (ICUs), with its prevalence ranging from 36% to 89%. Lower respiratory tract infections (LRTIs) are known to be the primary site of infection related to sepsis in critically ill patients in Brazilian ICUs and are associated with high morbidity and mortality.
It is well established that the oral cavity is a source of pathogens leading to LRTIs in critically ill patients, with dental plaque serving as an important reservoir of these pathogens. Therefore, oral hygiene in critically ill patients is an essential measure for the prevention of LRTIs, as recommended by both international and national guidelines.
Simple cleaning of the oral cavity using a toothbrush or oral swab, in addition to providing comfort and well-being to the patient, contributes to the prevention of LRTIs and other infections. A recent meta-analysis evaluating the impact of standardized toothbrushing on clinical outcomes showed that this care intervention was associated with a lower incidence of LRTIs and reduced mortality. On the other hand, an international clinical trial demonstrated that the implementation of an oral care bundle combined with the de-implementation of chlorhexidine for oral care was not associated with improved outcomes.
Based on the rationale supporting the benefits of implementing a standardized oral care, findings from previous studies, the conflicting literature regarding the effectiveness of oral care protocols that include the de-implementation of chlorhexidine on clinical outcomes in ICU patients, and the scarcity of data from developing countries such as Brazil, conducting a clinical trial is needed.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 4800
- All patients who receive mechanical ventilation in the participating intensive care units
- Does not meet inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Ventilator free days 28 days after enrollment Days alive and free from mechanical ventilation
- Secondary Outcome Measures
Name Time Method Intensive Care Unit all cause mortality 15 months All cause mortality during intensive care unit stay
Hospital all cause mortality 15 months All cause mortality during hospital stay
Ventilator associated pneumonia incidence 15 months Defined as the number of ventilator associated pneumonia cases adjusted per ventilated-patients/days
Intensive care unit free days 28 days after enrollment Days alive and free from intensive care unit
Hospital free days 28 days after enrollment Days alive and free from hospital
Trial Locations
- Locations (6)
Santa Casa de Misericordia de Passos
🇧🇷Passos, Minas Gerais, Brazil
Hospital Municipal de Maringa
🇧🇷Maringa, Parana, Brazil
Hospital da Restauracao
🇧🇷Recife, Pernambuco, Brazil
Hospital Santa Cruz
🇧🇷Santa Cruz, Rio Grande Do Sul, Brazil
Hospital Nereu Ramos
🇧🇷Florianopolis, Santa Catarina, Brazil
Hospital Leo Orsi
🇧🇷Itapetininga, Sao Paulo, Brazil
Santa Casa de Misericordia de Passos🇧🇷Passos, Minas Gerais, BrazilPriscila GoncalvesContact