Infection Prevention, Mechanical Ventilation, Oral Care, Oral Hygiene, Oral Health, VAP - Ventilator Associated Pneumonia
Conditions
Keywords
Oral care, Oral hygiene, critically ill, mechanical ventilation
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.
Interventions
OTHEROral hygiene bundle
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.
Sponsors
Faculdade de Medicina de Ribeirão Preto/USP
Hospital do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a stepped wedge cluster randomized clinical trial, with a 11-month transition period between interventions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients who receive mechanical ventilation in the participating intensive care units
Exclusion criteria
* Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator free days | 28 days after enrollment | Days alive and free from mechanical ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Contacts
Primary ContactBruno M Tomazini, MD
Backup ContactWanessa Belissimo-Rodrigues, PhD
Outcome results
None listed