An interventional study of Oral hygiene bundle in Mechanical Ventilation, Infection Prevention and Oral Care, sponsored by Hospital do Coracao. Not yet recruiting at 6 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by Hospital do Coracao · Not applicable, Interventional, and Prevention
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.
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.
392 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 81 are open to participants now.
This study's planned enrollment of 4,800 is above the median of 122 across 254 interventional studies indexed under Pneumonia, Ventilator-Associated.
Browse Pneumonia, Ventilator-Associated studies →Hospital do Coracao is the lead sponsor of 66 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This arm will receive the standardized oral hygiene bundle
Other: Oral hygiene bundle
Each center will maintain its usual oral care practices.
Implementation of the standardized oral hygiene bundle, which consists of the following key components: Standardization of materials used during the oral hygiene procedure, standardization of oral hygiene frequency, training of nursing staff involved in patient care on proper oral hygiene practices, discontinuation of routine application of chlorhexidine oral solution, and implementation of a standardized oral hygiene technique.
Ventilator free days
Days alive and free from mechanical ventilation
Time frame: 28 days after enrollment
Intensive Care Unit all cause mortality
All cause mortality during intensive care unit stay
Time frame: 15 months
Hospital all cause mortality
All cause mortality during hospital stay
Time frame: 15 months
Ventilator associated pneumonia incidence
Defined as the number of ventilator associated pneumonia cases adjusted per ventilated-patients/days
Time frame: 15 months
Intensive care unit free days
Days alive and free from intensive care unit
Time frame: 28 days after enrollment
Hospital free days
Days alive and free from hospital
Time frame: 28 days after enrollment
Plan to share: Yes — Individual patient data (IPD) might be shared upon request and approval by the study committee after the study completion.
Supporting information: Study protocol, Sap
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Pneumonia, Ventilator-Associated→
Hospital do Coracao