Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07129733

Oral Care Layered Enhancement for Improved Oral Hygiene in Intensive Care Units

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Casa de Misericordia de Passos, Passos, Minas Gerais, Brazil

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Does not meet inclusion criteria

Treatment and study plan

Oral hygiene bundle

Other

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.

Primary outcomes

  1. Ventilator free days

    Time frame: 28 days after enrollment

    Days alive and free from mechanical ventilation

Secondary outcomes

  1. Intensive Care Unit all cause mortality

    Time frame: 15 months

    All cause mortality during intensive care unit stay

  2. Hospital all cause mortality

    Time frame: 15 months

    All cause mortality during hospital stay

  3. Ventilator associated pneumonia incidence

    Time frame: 15 months

    Defined as the number of ventilator associated pneumonia cases adjusted per ventilated-patients/days

  4. Intensive care unit free days

    Time frame: 28 days after enrollment

    Days alive and free from intensive care unit

  5. Hospital free days

    Time frame: 28 days after enrollment

    Days alive and free from hospital

Study contacts

Contact information is provided by the study sponsor or research team.

Bruno M Tomazini, MD

CONTACT

[email protected]

+5511982839173

Wanessa Belissimo-Rodrigues, PhD

CONTACT

[email protected]

+111699963-8236‬

Sponsors and collaborators

Lead sponsor

Hospital do Coracao

Other

Collaborators

  • Faculdade de Medicina de Ribeirão Preto/USP

Registry information

Official study title

Oral Care Layered Enhancement for Improved Oral Hygiene in Intensive Care Units: A Stepped-Wedge Cluster Randomized Clinical Trial

Acronym: ORACLE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.