About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients who receive mechanical ventilation in the participating intensive care units
Disqualifiers
Does not meet inclusion criteria
Trial design
Sequential
Treatments tested in this trial
Oral hygiene bundle
Other interventionImplementation 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.
Treatment groups
Trial outcomes
Primary outcomes
Ventilator free days
Days alive and free from mechanical ventilation
Secondary outcomes
Intensive Care Unit all cause mortality
All cause mortality during intensive care unit stay
Hospital all cause mortality
All cause mortality during hospital stay
Ventilator associated pneumonia incidence
Defined as the number of ventilator associated pneumonia cases adjusted per ventilated-patients/days
Intensive care unit free days
Days alive and free from intensive care unit
Sponsors and contacts
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Hospital do Coracao
Lead sponsor
Faculdade de Medicina de Ribeirão Preto/USP
Collaborator
This trial is not recruiting at the moment. You can still explore other options: