Oral Care Layered Enhancement for Improved Oral Hygiene in Intensive Care Units (ORACLE)

Hospital do Coracao

Status: Not yet enrolling

Conditions: Infection Prevention; Oral Care; VAP - Ventilator Associated Pneumonia; Oral Hygiene, Oral Health; Mechanical Ventilation

Treatments: Other: Oral hygiene bundle

Study type: Interventional

Funder types: Other

Identifiers

NCT07129733

ip_hcor_oracle

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who receive mechanical ventilation in the participating intensive care units

Exclusion criteria

• Does not meet inclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

4,800 participants in 2 patient groups

Oral hygiene bundle

Experimental group

Description:

This arm will receive the standardized oral hygiene bundle

Treatment:

Other: Oral hygiene bundle

Standard of care

No Intervention group

Description:

Each center will maintain its usual oral care practices.